The Leading Difference

Sanjiv Prabhakaran, CEO of Bytes, and Tim Reynal, founder of Ingenyx, discuss how medtech teams can de-risk development and accelerate FDA readiness. Sanjiv shares how Bytes helps companies solve complex workflow problems, including using AI to cut QA test script creation from weeks to days and speed the path to approval; Tim explains why startups consistently underestimate time, cost, and regulatory rigor, and how early risk identification prevents runaway budgets. Together they unpack practical guardrails for AI in regulated environments: why humans must govern the work, why FDA won’t accept straight AI outputs, and how multilingual device testing raises hidden safety risks, plus leadership lessons on empowerment, integrity, and listening.    Guest links: https://ingenyx.com/ | https://bytesinc.com/  Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 092 - Tim Reynal & Sanjiv Prabhakaran Tim Reynal & Sanjiv Prabhakaran [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am delighted to welcome Tim and Sanjiv to the podcast. Tim is the founder of Ingenyx and the originator of the human-led AI Fit engineering framework, a forward-leaning model that redefines how complex systems are designed, tested, and brought to market. With nearly three decades of experience in enterprise technology and regulated environments, he has built his career at the intersection of engineering discipline, operational execution, and emerging AI capability. Sanjiv is the CEO of Bytes. Bytes partners with medical device companies to de-risk development programs, strengthen regulatory readiness, and accelerate the path to m-market. Innovation moves fast, regulatory risk moves faster. Bytes helps medtech companies stay ahead of both. Their consultants combine deep medtech engineering expertise, regulatory and compliance experience, and system-level thinking across hardware, software, and clinical workflows. All right, Sanjiv and Tim, thank you so much for being here today. I'm really excited to speak with both of you. [00:01:54] Sanjiv Prabhakaran: Thank you. Yeah. Thanks for hosting us. [00:01:57] Lindsey Dinneen: Of course. Well, I would love to start by finding out a little bit more about each of you. So we'll start with Sanjiv, but I would love to learn sort of who you are, what your background is, and what led you to medtech. [00:02:14] Sanjiv Prabhakaran: Good questions. So, well, basically I'm an, you know, by trade, I'm an engineer and an entrepreneur at heart. So I have kind of spent about 20 years plus at the intersection of like complex operations and software and have been kind of helping a lot of small to mid-size companies in their challenges with operations and workflows and, you know, when it comes to medical devices, you know, what are the processes that are involved in getting to FDA approvals and test materials. So after serving as VP of engineering for an e-business firm, I founded Bytes back in 2002, and since then, the focus, like I said, has been primarily on helping all these small to mid-size companies, especially in medtech and AI. The whole idea is solving their impossible workflow problems. And that's kind of where, you know, we bring in experts like Tim and other engineers who have that. Sp- In addition, I hold nine US patents, which reflects my passion for building things that don't exist yet. So that's, that's the fun part. So that's in a nutshell about what Bytes is all about and how we are excited with this whole medtech industry now. [00:03:44] Lindsey Dinneen: Yeah. Awesome. Okay, I definitely have things I wanna dive into, but Tim, I'm gonna let you introduce yourself first, and then we'll keep the conversation going. [00:03:53] Tim Reynal: Sure. So what got me into medtech? Probably like most people, when I graduated from college, I never in a million years thought this is where m-- I would end up. But through the process of organizational evolution and companies that got acquired and so forth, here I am. What draws me to medtech is very much that medtech has real risk, and companies often underestimate the risk upfront. And my goal, my job as a consultant to these medtech companies, is really to help them identify risk early, de-risk, and help cost containment from going out of control, 'cause that's, that's the, the biggest failure point I think in most medtech. It's not a get-rich-quick industry by any means and people lose a lot of money trying to get their product commercialized. [00:04:48] Lindsey Dinneen: Yeah. Yeah, absolutely. And again, so much to dive into. I love that. So, so Sanjiv, so I'm curious, when you were-- th- and this will go for both of you, honestly, but when you were growing up, did you-- could you have imagined that you'd be where you are now? Have you always been, you know, super curious and wanting to kind of tinker with things and solve problems? Or where did this interest develop from? [00:05:14] Sanjiv Prabhakaran: Yeah, that's a good point. I mean, the-- in my early days itself, I had this whole thing about, you know, breaking things apart. Like the-- my dad would have some equipment at home, I would break it apart and see what's inside. And so, and, you know, I, I, I get those, those early days punishments for that, you know? But, but that's kind of where the whole interest kind of started. And from that, you know, even in school projects, I would, you know, have the opportunity to build this old type of telephone systems that you, you know, you pick up a string and you talk to the other end and get some electronics into it and things like that. So it was those fun days. But that's kind of where it evolved and you know, when I was in the industry heading as VP in R&D, VP of Engineering and R&D, things would pop up that would really you know, have clients you know challenged with certain types of solutions. And you know, my whole goal there was, okay, what kind of things can we do to alleviate the clients' problems? And so it was always that of solving things as, as efficiently as possible and which drove me to kind of eventually start Bytes to handle those kinds of issues that clients face. [00:06:31] Lindsey Dinneen: Yeah. Yeah, absolutely. And so, you know, you, you talked a lot about liking problem-solving and, and designing things or creating things that don't exist, right? And so you're, you're passionate about innovation and where it meets, you know, these engineering solutions to things. And so I'm, I'm wondering if there are any projects that you have undertaken with Bytes that kind of stand out as particularly meaningful or I don't know, revolutionary, something that just kind of stands out as? [00:07:04] Sanjiv Prabhakaran: Yeah, that's a, that's a good good point there. I would say especially in the recent days when we got involved in the medtech industry, one of the biggest challenges of this particular client was facing was getting QA test scripts built as, as quickly and efficiently as possible. So when our consultant got in there, the initial challenges, they were already six months behind because of all the backlog. And and the, you know, when our s- when our consultant started looking at all the pain points and what could be done, the, the best solution was to utilize some of the AI tools that are out there to kind of see how we can streamline and speed the process, speed up the process. And so in the end you know, cutting short the story there, it, you know, what used to take three to four weeks, they were able to bring that down to, like, within a day or two. So the amount of manual labor that could, you know, was able to, you know, that we were able to efficiently reduce, saved a lot of time and speeding up their whole you know, process towards, towards FDA approval. So those kinds of, you know, that was a big, big aha moment kind of thing. Okay, this is really good what we can do to not only save lives, you know, save product development cycles and help teams or even developers understand the power of, you know, ethically and, and correctly using AI so tools. So, so that's, that's kind of the the big moment that, that really started to shape up once, once we got. So that was a good example, a very recent example, I would say. But there are a lot more, you know, from the past which, which are pretty interesting, so. [00:08:47] Lindsey Dinneen: Yeah. [00:08:49] Tim Reynal: Can I piggyback to what Sanjiv was saying about this particular project? Because I think your listeners will be fascinated by one of the biggest challenges in the medtech industry is in today's world and with AI, you've got these medical devices that need to be able to translate, it might be as many as 50 different languages, and they have to be right. Right? You can't, you can't have a mistranslation on a device that's hooked up to a patient. And so one of the most fascinating things, again, that AI is really helping us do and move more quickly on is building the multi-langua- multilingual functions into these devices. And that's one of the things that the project that Sanjiv's talking about had to be conquered, and it was one of the reasons they were running so far behind because again, you've got all these multi languages, but you have to test every single one and every single word that these devices depend on and make sure there's no possibility of mistranslation. [00:09:48] Lindsey Dinneen: Oof, yes. That, yes, and that's... [00:09:50] Sanjiv Prabhakaran: Very good point. Yes. [00:09:53] Lindsey Dinneen: Exactly. I mean, the, some of the things that you-- Well, well that in particular is such a great example of a risk that you might not even consider. Like, you might, it might just be one of those things you go, "Oh, shoot," kind of after the fact. And so, you know, that also brings me to, and I'm curious, from when you were a kid, Tim, were, were you constantly, you know, trying to, like, de-risk situations? [00:10:19] Tim Reynal: Yes. And I just learned something about Sanjiv that we have in common because I was about 12 years old, I took the lawn- the family lawnmower out to the driveway, and I completely tore it apart 'cause I needed to know how it worked. And my father came out and saw the lawnmower in pieces all over the driveway, and he told me, "You have three hours to get that lawnmower back together or you are going to be in your room for weeks." So yes, I, I love technology and I'm the biggest proponent of get the right tool for the job, get the right engineer for the task, do it right the first time and it'll save you a lot of money, but it will also reduce your risk. It's part of the de-risking process, is get the right, the right tools, the right person on the job. [00:11:10] Lindsey Dinneen: Yeah, and that's great because I wanted to ask you about exactly some of the-- maybe some of the common things you see medtech startups struggle with when they are, you know, really early on and perhaps this is their first time trying to bring a device to market, and you're trying-- you're coming in as the expert and saying, "Hey, here's what I'm seeing. Here's how I can help." But what are some of the common things that maybe trip up medtech startups at the beginning? [00:11:37] Tim Reynal: That is a great question, and the-- it, it's 100% across the board. The people that have a startup come in with a vision and a product, and it's usually a great concept, it's usually a great prototype, but they have no idea of how long it's gonna take, how much it's gonna cost, and what kind of risk they're gonna encounter. And then there's the whole regulatory compliance side where they really they just have no idea of how rigorous the FDA process is to get through to your 510 approval so that you can go to market. And so they always underestimate that effort. [00:12:18] Lindsey Dinneen: Hmm. Hmm. Yeah, that's-- Oof. That's, that's-- I'm so glad there are people like you out there helping these, these, you know, companies because, yeah, we want them to succeed. We want those-- that technologies to be brought to market. So yeah, that's, that's wonderful. Now, you know, you mentioned AI. It's obviously a hot topic across all sorts of industries. I'm wondering how-- this is another interesting avenue of de-risking-- how do you balance potentially some of the challenges or potential pitfalls with AI versus obviously it can do an incredible amount of, of good too? So I'm, I'm curious how you kind of balance that. [00:13:01] Tim Reynal: Well, I balance it with a, a, a slogan that I've coined called "Human-led, AI fed." And the idea is that you never wanna turn AI loose in medtech or any other industry and think that it's going to do the complete job without the human intervention. It's the human intellect that ca- that has to govern what AI can do. And the human thought beforehand, if it's well thought out and what you're asking AI to do, you'll get a very good result. If it's poorly thought out and you ask AI to do it, you're gonna have a lot of human interv-intervention afterwards. So the human involvement is all the way through the AI cycle, and a lot of companies don't realize that. They, they have, ... In one of my, my, my day job right now, the amount of AI tools at our disposal, I probably have 20 to 30 different AI engines and agents that I can work with. How do I know which one I should use, right? How do I know which one is the best one? And now there's AI agents that will help you make that decision too. But you know. So I, I joke around with some of my coworkers is "My AI agent is gonna speak to your AI agent." [00:14:20] Lindsey Dinneen: Yeah. Yeah, that's the, the new "My people will call your people" kinda? [00:14:25] Tim Reynal: Exactly. [00:14:28] Sanjiv Prabhakaran: That's right. I know there are, there are boardrooms that now are run by AI agents, right? So it's kind of funny. But yeah, Tim, Tim hit the point right there, Lindsey, is you need that human control, human intervention. Even in our development team that we, you know, we-- the teams use the AI tools to, to create some base found-- baseline coding, but to fine-tune it, you need a real well-trained engineer to really go through that. It will save time, but at the same time, you know, it, it definitely needs that correction where, where it's required, so. [00:15:04] Lindsey Dinneen: Yeah, absolutely. [00:15:06] Tim Reynal: And for the, for FDA, they don't accept a straight AI response. So, they, they have tools that will detect that something was all driven by AI, and so they will only accept a human submittal. So, that's important to know because again, we get back to that risk. It takes a human mind to make sure that we're not gonna kill a patient or a clinician with a product we put out there. [00:15:32] Lindsey Dinneen: Yeah. So having those guardrails in place is really helpful and imperative really. Yeah. Okay. Yeah. Okay, so, you know, both of you have had some really incredible careers so far, and I would love if you would share a little bit about your leadership style and philosophy and, and maybe some lessons learned along the way as you've built companies and, and been in these, these leadership roles. That would be awesome. [00:16:03] Tim Reynal: Sanjiv? [00:16:04] Sanjiv Prabhakaran: Sure. Yeah. Okay. I mean, mine is very simple. You know, leadership, it's, for me, it's the art of empowerment through clarity. That's kinda what we look at. So, you know, it's, it's not about having all the answers, but it's, you know, about providing the vision and the tools that our team feels confident enough to find those answers themselves, right? So, so at Bytes, you know, I, I view my role primarily as, you know, removing that, that friction layer so the team can basically do the best work. And that way it, it, it kind of motivates the team members, it motivates the developers and, and everybody else in the team to kind of put out their best. So, so that's kind of the way I look at, you know, how, how my style would be and, and my style is and what I like to do. [00:16:54] Lindsey Dinneen: Awesome. How about you, Tim? [00:16:59] Tim Reynal: So this is where Sanjiv and I partner very well together. One, we are great collaborators, but I take the approach the older I get, the more I realize people need and want to be heard before they're gonna listen to anything I say. And so I-- in order to solve their problem, I have to hear what their problem is, and I have to hear their perspective on it. So I'm learning to sit back and listen and not feel like I'm the expert that has to speak. And often the more I listen, the more I realize that my initial answer is gonna change based on what I've heard. And I think good leadership, first of all, lead with high integrity and honesty and transparency, but listening is one of the hardest things human beings have to, to learn. [00:17:48] Lindsey Dinneen: Yeah. It is. But it is such a great skill set, and I, I find that it's kind of fun, because the more curious you are, the more you just learn something new every day. And s- people can teach you so much, you know? [00:18:04] Tim Reynal: Yes. [00:18:04] Lindsey Dinneen: Yeah. Yeah. Okay. Yeah. Yeah. So, all right. S- so you, you have these again, really exciting things. I would love to hear more about what excites you about trends in the industry, but also about the company in particular, and just sort of what is, what is driving your next level of, you know, passion for what you're doing? [00:18:30] Sanjiv Prabhakaran: Hmm. [00:18:31] Tim Reynal: Oh, for me it's-- that's an easy question to answer because we are now, with the advent of AI, we are able to solve things we never thought the human being would be able to solve when it comes to DNA chains and proteins and all of that. And so to me, I'm just fascinated by how fast the m- medical device community or industry is moving to, to leverage the power of AI and the stuff that we're seeing, I mean, just even in surgical robots that I've been able to have exposure to and, and work on some of those projects, we're able to do things to the human body we just never even imagined we could do, all with a surgeon that's not even, not even in the same room. They can do it from across the world, and that to me is just-- that's fascinating. Think about what that means for going into outer space and being able to take care of astronauts that are, you know, en-en route to Mars. We think, we think that's an impossibility, right? But we're gonna make it happen. [00:19:34] Lindsey Dinneen: Yeah, there you go. Love it. And how about you, Sanjiv? [00:19:38] Sanjiv Prabhakaran: Yeah. Yeah. No, that's-- Yeah, no, I think Tim covered most of the points there. That's, that's the excitement in the industry. And for us also, you know, we, you know, I deal with not only with medtech, but other enterprise software also. And so what happens is, you know, now with all these AI tools that are out there, you know, you can, you can cut down a lot of the in efficiency in, in operations between different software systems and be able to tie all those together and provide a much cleaner dashboard that automates a lot of the process. Like, for example, one of the clients we are dealing with is you know, they deliver what do you call, lubricants to, to and different types of you know, lubricants that they deliver. But many times, you know, the amount ordered is different from the amount that was delivered. And so now, you know, the piece of paper and basically says, you know, asks this, the client to sign off and say, "Hey, I only got one hundred and fifty instead of five hundred." And that, all that bunch of paper comes back, and now the admin has to go put that, all that into the system in a manual process, right? You read through that. So we are looking at, you know, systems where you can OCR scan that sheet and extract the right number. I mean, it has to obviously read the handwriting and all those things. So it's, it's a, it's a, it's a mundane process, but if you can automate all of those with smart AI tools now, which we are, we, which we are able to do, it, it, it creates a lot of difference in in the, in the overall operation. Yeah. So, so that's, that's kind of where the whole thing is heading. [00:21:11] Lindsey Dinneen: Yeah. That's, that's-- that is so exciting, and I think, I'd love your perspective too. You know, there's, there's both of you 'cause AI is something that you believe so strongly in, and I think it's really incredible to see the innovation and you both sort of alluded to the speed that which, you know, things can get to market faster perhaps, like, we could just m- be more efficient at our jobs and then create more impact hopefully. And so I'm curious what you would say to anyone who's kind of just still nervous perhaps about the use of AI, whether they're nervous about proprietary information or things like that. What are the, what are the best practices so that, you know, somebody who might be a little concerned feels more at ease? [00:21:57] Sanjiv Prabhakaran: Right. Right. Yeah, I think, you know, in that situation, it's always, you know, there is always apprehension about anything new, right? When, when banking systems came and said "you can do online banking," nobody wanted to do that, right? It took, it took some time for people to, you know, scan the check and deposit it through your mobile phone. Nobody would do that, right? So, so, so those are the kinds of changes that will evolve. And people right now, the cha- the, the biggest problem is AI is moving at a much rapid pace. So if you don't train yourself or if you don't take that step, it's going to put you behind and, you know, everybody else will be moving forward, right? So that's, that's a, it's a very, very tough decision for people to make. I know there, there's all this question about privacy, but that's been-- I mean, everybody's privacy is out in the market now. With all the hacks and with all the, you know, things that have happened, there's nothing more to hide, right? So, so how much more can you protect? But at the same time, you do wanna be careful what you put in there and make sure that your account, you have a valid account that is secured and, you know, take the basic protection steps there. Turn off, you know, you can go into the privacy settings, turn off what you don't like, and, and to use it and and take advantage of these tools. That's the only way to take, you know, take one step at a time. Take one tool, do try it out, you know, learn, learn about it and, you know, figure out what it does and very soon you'll get used to it and, and start exploring more. So that's, that's my take. [00:23:30] Lindsey Dinneen: Love it. Tim, anything to add to that? [00:23:33] Tim Reynal: Sure. So for people who have a fear of "AI is gonna take my job away," AI is definitely reducing headcount across all of tech including medtech. What it doesn't take away is the human intellect that keeps pace with AI and that it it-- that people know how to govern AI and put it to good use. So for people who can see how requirements, design, and testing connect and where they disconnect, that's when you become very valuable to companies, especially in a consulting role. So for people coming out of college that are looking, "how do I adapt to this?" Is first of all, understand what AI can do and what it can't do, and then learn how to identify gaps and risks because of AI, and you become very valuable, especially as an engineer. [00:24:26] Lindsey Dinneen: Yeah. Yeah. That's great. Well, okay, so this has been a great conversation so far, and I really appreciate both of your inputs and just advice and all of those good things. I do wanna pivot the conversation a little bit just for fun. So I'll ask you both the same question. You can decide who goes first, but all right, imagine that you were to be offered a million dollars to teach a master class on anything you want. Can be within your industry, but it doesn't have to be. What would you choose to teach? [00:25:00] Tim Reynal: I can go. Yeah, very easily it would be how to fail gracefully. [00:25:05] Lindsey Dinneen: Ah, okay. [00:25:07] Tim Reynal: Because failure is the only way th-that we learn how to do it better, right? So if you're successful at everything you do, and I certainly have not been, but it's the failure that has always helped me grow and has taught me the most. [00:25:22] Lindsey Dinneen: I love that. Great masterclass. [00:25:24] Sanjiv Prabhakaran: Cool. Nice. Yeah. So, for me, I would think, you know, having been running this business for so many years the art of simplifying the complex. That's kinda what I would, I would look at as you know, whether it's explaining a patent pending algorithm or teaching someone how to organize a chaotic business, you know, I love that, that whole translation process. So that's probably what I would teach, how to make any massive, you know, goal or intimidating goal and break it down into logical executable roadmaps. [00:25:58] Lindsey Dinneen: Yeah. Okay. Love it. Great masterclasses. All right, and then how do you wish to be remembered after you leave this world? [00:26:09] Sanjiv Prabhakaran: Ah, Tim, you want to go on that? [00:26:11] Tim Reynal: Sure. I want to be remembered for a person with kindness who helped people feel validated and important. [00:26:23] Lindsey Dinneen: I love that. Awesome. Sanjiv? [00:26:26] Sanjiv Prabhakaran: Okay. For me, I would say someone who built bridges. So, you know, specifically bridges between technology and human needs. That could be one of the topics that I would like to be remembered about [00:26:40] Lindsey Dinneen: Yeah. Excellent. Awesome. Okay, and then final question: What is one thing that makes you smile every time you see or think about it? [00:26:51] Sanjiv Prabhakaran: That, that would be seeing a complex plan finally click. So I like to see the client's reaction to that. That's, that's what I-- we solve a a challenging problem, whether it's an operational headache or, or something that you know, the team is trying to realize within their organization. When you see something working after what we have built, then that aha moment on their face is, is always the best thing that makes me smile. [00:27:23] Lindsey Dinneen: Love it. [00:27:24] Tim Reynal: So Sanjiv is giving you the politically correct answer 'cause it's really his grandkids. [00:27:30] Lindsey Dinneen: Sure. [00:27:32] Sanjiv Prabhakaran: Yeah, that is true. They just made me smile this weekend, so that's never, never a bad thing. [00:27:41] Lindsey Dinneen: Yeah. Awesome. How about you, Tim? [00:27:45] Tim Reynal: So the one thing professionally that makes me smile is seeing anybody that beats the odds, that goes against the odds and, and gets, gets to where they were hoping to go, attains the goal. I think seeing medic- the evolution of medical technology always makes me smile, and being able to be a part of it makes me smile. Now again, that's my politically correct answer, but as Sanjiv knows, I'm an avid gardener. We, we refer to our backyard or our whole yard as the Reynal Botanical Garden because we have just about every kind of hybrid plant, tree, flower in our yard that we can fit. And so what... [00:28:25] Sanjiv Prabhakaran: He's got 6,000 bulbs. [00:28:28] Tim Reynal: Yeah. Bulbs, yep. And when I see something go from a seed to a full-on plant and flower, that makes me smile. [00:28:37] Lindsey Dinneen: Love it. Oh, that's fantastic. Well, this has been a wonderful conversation. Thank you both so much for joining. And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to support and thank you for, like I said, sharing your expertise and your advice and stories with us, and we just wish you the most continued success as you work to change lives for a better world. [00:29:13] Tim Reynal: Thank you for having us. [00:29:14] Sanjiv Prabhakaran: Thank you, Lindsey. Yeah, thanks for having us. It's been fun. [00:29:18] Lindsey Dinneen: I agree. All right, till next time. [00:29:21] Tim Reynal: Take care. [00:29:22] Sanjiv Prabhakaran: Yes. [00:29:23] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Chengetai Nkiwane, founder of Girl in MedTech and a staff supplier quality engineer at a top 10 medtech company, discusses her journey from food manufacturing in Zimbabwe to medtech in Ireland and why she created the global community she wished had existed during her transition. Chengetai shares how transferable quality skills—risk management, QMS, and compliance—helped her move from consumer safety to patient safety, and what her day-to-day looks like supporting suppliers to ensure components meet the highest standards. The conversation covers leadership that makes people feel seen, “done is better than perfect,” authentic networking, and her mission to make room for more women to thrive in medtech.   Guest links: https://www.linkedin.com/in/chengetai-nkiwane | https://girlinmedtech.com/ |  https://girlinmedtech.substack.com/ | https://www.instagram.com/girlinmedtech |  Charity supported: Opportunity International Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 091 - Chengetai Nkiwane [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. /Hello, and welcome to another episode of the Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest Chengetai Nkiwane. Chengetai is the founder of Girl in Medtech, a global community that exists to champion women in the medical technology industry, where girls and women in medtech find their people, their power, and their place. She is also a staff supplier quality engineer at a top 10 medtech company and a strong advocate for women in medtech and STEM. A National University of Science and Technology alumna with a first class honors in applied biology and biochemistry, she transitioned from food manufacturing into medtech after relocating from Zimbabwe to Ireland and built the community she wished had existed when she made that leap. She has 13 years of professional experience in quality. [00:01:37] Lindsey Dinneen: All right. Well, welcome to the show. I am so glad to see you here today. Thank you so much for joining me. [00:01:44] Chengetai Nkiwane: Thank you for having me, Lindsey. [00:01:46] Lindsey Dinneen: Of course. I would love if you would start by sharing just a little bit about yourself, your background, and what led you to medtech. [00:01:55] Chengetai Nkiwane: Yeah, ah, that's a, that's a good one. So I'm Chengetai Nkiwane. I'm working in the medtech industry in Ireland. So a bit of my background. So I growing up, I've always been someone who was excelling. So I'd always be like the straight A student, and everyone expected that I'd be a doctor. So like during, when we had the prize-giving ceremonies typically in high school when you were sitting b- like we'd have certain desk, like a, like a full bench that's assigned to, to like the grade. And then say everyone would then be given a prize based on like a subject, best in maths, best in biology, best in everything else. And year after year, I'd always be the only one sitting on the desk. So to say straight A student, I'd be the only one there. So because of that, I've always excelled, but I didn't get a lot of career guidance or mentorship growing up, so I wasn't very-- I didn't know exactly what it is that I wanted to go into. And then I moved into the food industry after I graduated with my degree in applied biology and biochemistry. This was back in Zimbabwe. Moved into the food industry, went through, I was an intern initially in quality, then moved up into microbiology and then from there, food safety and quality manager. So all that was in the food industry. Then come 2019, moved to Ireland, international move during COVID. That is a story on its own as well there. And then transitioned into medtech, where I started in as a senior quality engineer and then currently I'm a staff supply quality engineer in medtech as well. So that's just a bit of my background, where I've come from and where I am now. Yeah. [00:03:44] Lindsey Dinneen: Amazing. Thank you so much. So I have so many questions for you. I'm really excited to have this conversation, and lots of different things come to mind right away. But one of the things that I would love if you would share about is, you have created this organization called Girl in MedTech, and I would love to hear sort of the origin story behind it. What made you think that this was something that was really needed in the marketplace? I'm a big proponent from the start. I'm really excited about the work you're doing. And of course, I think, of course, we need this in the world. But, you know, I'd love to hear about the experiences that led you to go, "This is really needed, and I, I can do this." [00:04:27] Chengetai Nkiwane: Okay. Yeah, no, thanks for that, Lindsey. So with Girl in Medtech, w- when I transitioned into the medtech space, I didn't really find like, anyone that reflected my experience or even just the community that I needed. So from that, I felt I needed to start and build that community, what I wished had existed when I transitioned. So from there actually, I actually started Girl in Medtech as a new mom, so I started it. I recently had a baby, so I think it just gave me time to then sit with it and realize, okay, "If I'm going to do this, I'm just going to do it." And I, I always go by the motto, "Done is better than perfect." So I don't want to keep procrastinating and saying, "Okay, I'm going to do it, I'm going to do it," but then I just was like, "You know what? It's something that I wished had existed." And after s- talking about it and, like, putting it out there in the world, so many people came back to be like, "You know what? This is me. I so need this, that community in the space." You know, typically women were so underrepresented in these, in the medtech space, in even STEM fields as well, so just having that community of women who comes together with mentorship, being there for each other, and also just even uplifting each other and encouraging each other as we go. So that was a big thing for me to what led me to start the Girl in Medtech. And, like, our mission is where girls and women in medtech find their people, their power, their place. So I think that truly exemplifies what exactly Girl in Medtech is. And yeah, it's, the response to it as well has been very has been phenomenal and amazing as well. Yeah. [00:06:06] Lindsey Dinneen: Excellent. Well, thank you so much for sharing that. And I'd love to learn what the, what the organization does right now. So I know that you have, for instance, mentorship opportunities open both for those who would, you know, be able to share their time as a mentor, and then also the folks that would like to have to be mentored. And so I was wondering, can you share a little bit about that and kind of what you envision that to look like? And then also, what are some of your things that you're excited about as you continue with this organization? [00:06:38] Chengetai Nkiwane: Okay. So with Girl in Medtech, currently we have a mentorship program, so where we're matching mentees with mentors. So it is basically for every woman in medtech, say people wanting to break in, people already in it, people who want to move to the next level within the organization. So it's within their different organizations. So it's for every woman who then wants to thrive in the industry. And also the good part about it, you have like-minded individuals, you have people that you can... i'm a big proponent of, you know, having that exposure to different people that they call it, I think, exposure therapy. The more you have that closeness or relatedness to people who are already in the industry doing the work, you then actually know you can do it. So for example, if someone sees me and they're like, "Oh, you know what? If she can do it, I can actually do it." So we have the mentorship space, and then we're also having the s- space for voices where, say, seasoned women in the industry come with their stories. Say, people who have pivoted in the industry, who have transitioned, say, like myself or people that, that just have unique stories to tell, we'd be good at showcasing that. And then we also have our newsletter as well, where we share medtech insights, events. And then I think f- in the future, we'd be looking to have like in-person events virtual events as well, just to have that community, especially in the medtech space, and just to have everyone represented and feel like they have a place where they belong as well. Yeah. [00:08:10] Lindsey Dinneen: Wonderful. That is very exciting. I'm so glad to see what you're building, and you know, as you mentioned, of course it's resonating with people because we do need that. And so I'm really thankful for you for stepping out and doing it. And I, I wonder so, so these, this mentorship opportunity, is this completely something where people can just apply and it's sort of a free exchange? Or how are you envisioning that to work? [00:08:35] Chengetai Nkiwane: So initi-- now at the beginning we have like our first cohort, we have the founding mentors and then the founding mentees. So as it stands, it's free. So anyone can sign up and then we'll have matching with the different mentors in the space depending on what exactly it is that the mentee is looking for. Then once we have that matching, we'll have the first cohort, and then I think later as the as the organization grows and develops, we'll then move to a membership and then also look to then host events globally. The, the nice part about Giving Medtech, we have a very big global footprint. So we're in 20 plus countries at the moment, and we have an increased number of members that are joining as well from all parts of the world. So, because of how global it is it'll, it's, it's we're definitely going to then have different events in the different yeah, in the different parts of the world as well. So yes, yeah, we're envisioning it to grow bigger and like ultimately just empower all the women, yeah, women in the medtech space as well. Yeah. [00:09:36] Lindsey Dinneen: Amazing. I love it. Okay, so you mentioned a couple of times the transition from going from the food industry to medtech. I know that that is-- can feel like a really steep learning curve, but I also know that you have found so many of the skills that you learned through the food industry and your experience there have actually translated really well to medtech. And I think one of the hesitations that some people might have is feeling like either that learning curve would be too steep or they don't actually have the transferable skills. But you're one of those people, living proof that not only is it possible, but sometimes it's a huge advantage. I would love if you would share just a little bit about your experience and how you feel that skills can translate that way. [00:10:22] Chengetai Nkiwane: Oh, yes. Perfect. So for me, definitely I saw how that worked in my career. The fact that-- so when I, when we moved to Ireland, when I was looking at the quality roles, quality engineering kept coming up even though I was in food industry. Then I was like, "Okay, this looks to be interesting." Then when I was now looking at the job description, I was like, "Okay, risk management, tick; quality management systems, tick; you know, compliance regulations." And then I just realized, "Okay, in as much as it's a different industry, but, like, the core principles are still the same. It's just that there's that move from moving from consumer safety to patient safety." And then after that, then looking more into the industry, seeing how impactful it is. You know, it's one of those industries where you feel like you wake up with a feel-good feeling because you're doing work that makes a difference, and you feel like, you know, you are helping people, people that would have otherwise wouldn't have had a second chance, getting second chances through the work that we do. So because of that, and yeah, it's so purposeful, I felt, "Okay, you know what? I have the transferable skills," and I went for it, applied, and then I actually got the role and I've been in medtech since, and it's, yeah, it's, it's like I feel like this, my story has come full circle because I feel like it's like a perfect fit of a glove when it comes to my career. [00:11:46] Lindsey Dinneen: Y-yeah. So okay, that is, that is perfect. Thank you for sharing that. And so I'm, I'm curious, you know, as you have had various opportunities to grow your own leadership skills, what are some of the things that have stood out to you in terms of good leadership examples? And then what are some pieces of advice perhaps for somebody who is interested in getting into medtech and potentially hoping to grow their career into leadership? So, so kind of on both sides, what are, what are some of traits of really good leaders that you've seen, and then how do you feel that, what is some advice exactly for those who would like to get into the industry? [00:12:28] Chengetai Nkiwane: Oh, okay. Yeah. Yeah, the leadership point is it holds a special place in my heart. So yeah, definitely I could talk about leadership all day. So for me with leadership, I feel it's, it's not about having all the answers. It's people that then come in and show the others, like to show people what exactly it is that they can do and what they can do in the industry. So for example, with the good leaders that I've seen are people that make people feel seen. People that make people feel less alone, feel supported, and know that there is, there's space for them. And I feel for, in my own experience, the leaders that have, like, played a major role in my career and in my transition and in just my whole career journey are people that made me seen. I felt supported. They mentored me. They gave me the support, held my hand, almost like held the door open for me to walk through it, which is ideally what you want in a leader. Then looking at advice that I'd give to someone who'd be wanting to get into medtech or eyeing a leadership role, you should always start before the title. So look to, you know, those stretch opportunities in your organization. Volunteer. Look for a mentor. It doesn't necessarily have to be like a formal mentorship, but it could even be just you shadowing that person, finding out exactly what it is that they do in work, just trying to be close to them or just spending the day and trying to find out exactly what it is that they do. Also even just looking at the relationships as well. I know in, in medtech, people are big proponents of the fact that your network is your net worth, and that's particularly true in this industry. You know, build those relationships before you need them. Get to talk to people, find out exactly what it is that that they do, have that relationship, and then from there I feel like when you have that in place, that makes it easier for you, say, with getting into a leadership role. Yeah. [00:14:33] Lindsey Dinneen: Absolutely. That's great advice. And I also appreciate your insights into leadership. There are so many things that you have said, both in this conversation today, but also we've had the opportunity to meet before this as well, and there's so much synergy all the time, and I was, I was excited to hear your, your enthusiasm for leadership in particular. But, you know, one thing that you said, and I, I'd love to come back to this 'cause this is also one of my favorite quotes, is, "Done is better than perfect." And as somebody who would always err towards perfection and had to learn how not to be like that... [00:15:09] Chengetai Nkiwane: Yeah. [00:15:10] Lindsey Dinneen: I, I would love to hear some of your, you know, why did you choose to adopt this as sort of a, a motto to go by, and then how do you do that in action in a way that still provides excellence? [00:15:23] Chengetai Nkiwane: Okay. Yep. That's one thing as well that I'm very passionate about. And like to your point, the done is better than perfect. It's something that I struggled with quite a lot, wanting to have everything perfect. But I realized behind that perfectionism, I was actually procrastinating or using it as an excuse to not do certain things. So I think just even in terms with like how I started Girl in Medtech, I had the idea for so long, but I kept pushing it back to be like, "Okay, no, I need... The website has to be perfect. The newsletter has to be perfect. I have to have X, Y, Z lined up and everything else." But then I think with life or just in general, you j- I then just decided, "You know what? I'm just gonna do it," and I hit publish. I was like, "Okay, we're going in for it." And then you c- on the excellence part, I feel it, it initially isn't excellent or perfect to begin with, but the more, like, when it's out there in the world, you can iterate, you can come back and fix, you can edit, and you can work on it. But like, if there's nothing to work on from the start because there's nothing there, then there's nothing. Yeah. [00:16:34] Lindsey Dinneen: Exactly. Exactly. Okay. Yes. Could not agree more. I think the way that you outlined that is absolutely perfect. I-- Ha, speaking of perfection. Oh, gosh. [00:16:44] Chengetai Nkiwane: Yeah. [00:16:45] Lindsey Dinneen: So I think that you're absolutely right, and you have to start somewhere. I feel that there's often this hesitation to maybe even put yourself out there, and this is something that I'd love your input on, too, is, one of the things that you talked about was your network is your net worth, and part of that, too, is giving value and, and actually showing up. And I think one of the things that sometimes people struggle with, not just in this industry but in general, is "How do I show up, say, on social media like LinkedIn in a way that's actually adding value?" And I'd, I'd love to hear your thoughts on that in terms of building your network, making your connections, but also giving back in some way. So I'm curious how, how you handled that. [00:17:31] Chengetai Nkiwane: That's a great question, Lindsey. So for me with how I've handled just, I guess, that showing up I think I commented on something you posted recently about how substance over volume. So I know, like, in this world now where we have a lot of, like, I think AI-generated content and lots of information coming at us left, right and center, it's very difficult to show up authentically as yourself. I think for me with the connections and even just on social media, it's about, like, telling your story and then, a, a friend of mine always says "You know, when you-- like, the people that are for you will find you." So in this case that I was feeling like, "Okay, who would want to hear my story or who would resonate with it?" But the more you, I put it out, then I realized, "Okay, there are people that relate or see themselves in this. And then from there I think that it grows in, in that way." And then in terms of the network as well, you know, there are people that you look up to on social media, maybe people in medtech, people who are, like, who are doing like, big, big, big stuff in the medtech space. It's always good then to say if someone is, like, someone you look up to, you can always then reach out and then talk to them and then just build the relationship. I know, like, with one of, I've had that personally with one of the guests that was on your podcast before, so Marissa Fayer. So she's ah, yeah, she's been on the podcast, 25 years of medtech experience; absolutely legend, a legend in the industry. So as, She has the, a book that she wrote her new book "Undervalued to Unavoidable: Women's Health as Infrastructure." So I got the book, read it, gave a review, talked to her about it, tagged her, then just had that connection through that. So sometimes it's not per se having-- like, I know some people would want to do, like, the cold DM and everything else, but I think as you try to just show up authentically and as true to who you are, then the connections will come. So yeah, I'd say don't be afraid to put yourself out there. The right people that relate to your story and that will resonate with it will find you. Yeah, definitely. [00:19:46] Lindsey Dinneen: Excellent. Wonderful. So in your current role, I would love to learn about sort of what is a day in the life of you as this role like? I'm just kind of curious what are some of the things that you get to do on a daily basis that you particularly love. [00:20:01] Chengetai Nkiwane: Okay. Yes. So in, in my day-to-day, day in the life there's a lot of, I'm very outward-focused, so I work with a lot of suppliers-- so we do like we have a lot of different initiatives with the suppliers. So your improvement projects, audits. So essentially we are working, like we're right in the middle between the product and the patient, and we're trying to make sure that all the components that go into the life-saving medical devices, meet the highest quality standards. So that involves a lot of cross-collaboration across different, yeah, different sectors and even departments, and also just working with a lot of suppliers and collaborating with, yeah, collaborating with lots of suppliers and other teams across. But very interesting because it's never the same thing, like it's never the same thing twice. So there's always something new, something different, and you're always learning and growing as well. And yeah, I think because I have learner in my top five Clifton StrengthsFinders, I always find that just how unique and different the different perspectives and issues that we come across, how different they are. I'm always motivated because I'm learning something new every day. No day is the same in medtech, yeah, as I've come to realize. Yeah. [00:21:24] Lindsey Dinneen: Which is one of the reasons I love it. I, I think we have a lot of, like I mentioned, similarities in, in a few different ways, and one of them is just loving this industry and being so passionate about getting to work in a space that truly impacts patient lives, and it's really exciting to see. And even whatever role you're playing, it, it all matters and it's all important, and I think it's a, it's a beautiful thing to be a part of. [00:21:49] Chengetai Nkiwane: Yes definitely. I'd, yeah, definitely second that. Yeah, it's a beautiful thing to be a part of. Yeah. [00:21:54] Lindsey Dinneen: So as you move toward the future of both Girl in MedTech and also your career, what are some trends and things that you are seeing that you're excited about maybe within the industry itself but also just with the work that you want to do and are, are excited about contributing to? [00:22:14] Chengetai Nkiwane: Okay. Yeah, that's a great question, Lindsey. So trends that are upcoming that I'm excited about. I feel there's more representation of women within the space. So we're seeing a lot of women-led organizations. I know we've got wonderful organizations as well, MedtechWOMEN, we've got STRIPES. We've got so many organizations that are coming together to build communities around women in medtech. Yeah, including Girl in Medtech as well. So just people realizing the need and then coming up and showing that, you know, we're better together as women, and when we come together, we can create something truly beautiful. And then looking towards the future, I think just having more women represented in the rooms that we traditionally wouldn't be in. So in those rooms where decisions are being made, where we are... yeah, we are showing up, putting in the work, and then also just having that visibility and bringing our best selves to work every day. So yeah. I'm excited about that as well. Yeah. [00:23:18] Lindsey Dinneen: Yes. Excellent. Love that. Okay. So you are, you are based in Ireland, so I'm gonna ask a specific question about Ireland, if that's okay. So I, I know that Ireland is definitely known as a medtech hub, especially within Europe, and I'm curious about your experience working within the country and I'd love to hear a little bit about ecosystem within Ireland and maybe ways that other people can, should get involved in it. [00:23:46] Chengetai Nkiwane: Oh, okay. Yeah, no, that's a-- Yeah, that's a great question. Ireland is, is lovely. Like it's the... Yeah, I know a lot of people complain about the weather. I think I've moved to that side as well of complaining because of the rain all the time, but "bad the weather." I know a lot of Irish people like to say " bad the weather," like except. So yeah, I'm learning some some Irish lingo in there, yeah. So for me, the Irish medtech system is thriving and it's -- we have, I think nine out of the 10, top 10, the world's top 10 medtech companies have operations in Ireland, so it's a very -- It's like a hub for medtech in the industry. And like all the people that I've come across in the industry, particularly in Ireland, so friendly, so welcoming. People are always willing to help and, you know, give their perspective, show you direction, and just give like advice on what exactly, like if you have any questions around it. And generally there's a lot of like interconnectedness as well. I know we have the lots of events as well, like we have the Medical Technology Ireland. There's a lot of events and conferences and just a lot of a synergy within the medtech ecosystem. So it's very vibrant and like thousands of people are employed in the industry. And the, like it doesn't per se matter which company you're working at, but I think the whole ecosystem just comes together when it comes to events, and industry, yeah, industry-related topics and everything else. So definitely it's a, yeah, thriving and it's a, yeah. I'll, I'll say it the Irish way. "It's a great craic," yeah. [00:25:28] Lindsey Dinneen: Excellent. Excellent. I love that you're picking up on some of that. Oh, fantastic. All right. Well, this has been a fantastic conversation so far, but I would also love to pivot. Imagine that you were able to offer a masterclass on any topic that you want, could be within your industry, doesn't have to be, and you get paid a million dollars to do it. What would you choose to teach? [00:25:52] Chengetai Nkiwane: Huh. Okay. A million bucks is on the line here. Okay. Okay. For me, I think the masterclass, I think nothing beats lived experience in my case. So I think I would call my masterclass, "I Was the Only One in the Room and This Is What I Did About It." [00:26:15] Lindsey Dinneen: Ooh! [00:26:15] Chengetai Nkiwane: So I think it, it will be like an amalgamation of everything that I've gone through. And then just to show people, okay, if you have this, like all the lessons that I've learnt from my career transition, moving from medtech into moving from food, food manufacturing into medtech, just the community building that's happening with Girl in Medtech, the quality and compliance, the leadership as a Black African woman navigating the Irish medtech ecosystem. All that coming together and just showing to say even inasmuch as you could be the only one in the room, but this is what you can do. This is how you can-- I guess maybe change the narrative or use it for the greater good. And in this case, I feel like I actually already am doing that through Girl in Medtech. So, I think I'd then use that million bucks maybe to get the word out more or to have more women see it, more women come in and, you know, just continue to find their place and find yeah, their people, their power and their place. So in essence, I feel like I'm already somewhat teaching it, but yeah, the million dollars would be, would be great to amplify the, the message, you know, overall. Yeah. [00:27:31] Lindsey Dinneen: Yeah. There you go. I love that. And I love the fact that, as you said, you're already, you're already doing this. This is something that you're passionate about, you care a lot about, and so instead of waiting for the right time or the perfect time or whatever that looks like, which doesn't exist by the... [00:27:46] Chengetai Nkiwane: It doesn't exist. Yeah, it doesn't. [00:27:49] Lindsey Dinneen: Just started now with what you have, and I love that. All right. And so how do you wish to be remembered after you leave this world? [00:27:57] Chengetai Nkiwane: Ooh. That is a, yeah, that's a loaded question, Lindsey. [00:28:03] Lindsey Dinneen: I know. [00:28:04] Chengetai Nkiwane: Yeah. Okay. How do I want to be remembered when I leave this world? I want to be remembered as the woman who made room and space for other women to see themselves in this industry and thrive. I want, say a girl in Zimbabwe who can look at, at the industry and be like, "You know what? I can actually see myself in this industry and grow in it." I want to be remembered in the mentor who feels that they have to contribute and mentor someone and advise and support someone in their medtech journey because it's something that they've lived and that they've experienced. And I also want to be remembered, say, in the young woman who then decides, "Okay, you know what? Because I've seen someone who looks like me in this, in this position, in this industry, I can do it, too." And to give people, yeah, particularly women to be, you know what? It's something that's like, as women, we always feel like maybe we're overlooked or we are, we aren't the best to be in certain positions. But not to look at that as a limitation, but rather to look at it as your superpower and know that you can achieve great things. Yeah, that's... Yeah, I think that's, yeah, that's how I'd like to be remembered. [00:29:24] Lindsey Dinneen: That's a beautiful legacy, and I love that you're already living it, clearly, and that's... [00:29:28] Chengetai Nkiwane: No, thank you, Lindsey. [00:29:31] Lindsey Dinneen: ...Something that you're doing and is just gonna continue because, you know, your heart for people being seen and heard and valued is beautiful, and the fact that you are actively doing things to help people feel that way is a huge gift to the world. So thank you for already living your legacy. [00:29:51] Chengetai Nkiwane: Oh, thank you very much. I appreciate that. Yeah. [00:29:54] Lindsey Dinneen: Yeah. And then, okay, final question: What is one thing that makes you smile every time you see or think about it? [00:30:04] Chengetai Nkiwane: Ah, okay. For me, I think the one thing that makes me smile when I see it or think about it is, you heard it here first, Girl in Medtech. Why? Because I feel like it's the most authentically me thing that I've ever built in my life. Why do I say that? Because with Girl in Medtech, it's, it's a space where we're saying we want girls and women to find their people, their power, and their place, and it's the one place where every part of me exists. The little girl who was on the bench on her own because she won all the prizes and was excelling; the supplier quality engineer; the founder, the Zimbabwean woman who is in Ireland; the new mom; the community builder; all of those people belong at the same time. So for me, that's one thing that I-- that really makes me smile when I see, when I think about it or when I see even, say, the logos or the people resonating with the message. When I see, you know, a DM from someone to be like, "Oh my goodness, I so wish this existed. Like, I can't believe I c- I've come across this. This is exactly what I wanted. Like, this is something that I've been looking for, and it's so great to actually find it." So my transition has purpose, and the purpose of that is that it has actually formed the founding story of a global community, and this has connected me with women who have been in the position that I've been in. You know, when you're now trying to build almost credibility from scratch in a new industry-- I know one of your previous previous people on the podcast talked about how the acronyms in medtech, trying to navigate all that and everything else. So yeah, that's one thing that genuinely makes me smile whenever I think about it. Yeah, it might sound like cliche, but it's the honest truth. Girl in Medtech makes me smile whenever I see it or think about it, yeah. [00:32:22] Lindsey Dinneen: I love that so much. I love that for you, but I love that for the world because it's taking, like you said, sort of the whole essence of who you are and putting it into something that, that makes you smile. I mean, how amazing is that? I love it so much. [00:32:38] Chengetai Nkiwane: Yeah. No, thank you, Lindsey. Yeah. [00:32:40] Lindsey Dinneen: Awesome. Well, oh my goodness, this has been an amazing conversation. I am so thankful for all the work you're doing in medtech and beyond. Thank you for being brave and bold and putting yourself out into the world. Thank you for giving back. Thank you for also building an organization that is-- I mean, this is just the start. I can't wait to see how many lives are impacted by it, so. [00:33:04] Chengetai Nkiwane: Thank you so much. Yeah. [00:33:05] Lindsey Dinneen: Yeah, really grateful for you, really grateful for everything you bring to the industry. We are honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which designs, delivers, and skills innovative financial solutions that help families living in extreme poverty build sustainable livelihoods and access quality education for their children. So, we appreciate you picking that organization to support and we just wish you the most continued success as you work to change lives for a better world. [00:33:37] Chengetai Nkiwane: Thank you so much, Lindsey, and thank you for having me. It's been an absolute pleasure and yeah I can't wait to see what the future holds. And yeah, thank you so much for just this opportunity and yeah, thank you for everything. Yeah. [00:33:52] Lindsey Dinneen: Of course. Of course. And thank you to all of our listeners for tuning in, and go check out Girl in MedTech for sure. [00:34:01] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Kirk Petyo, Executive Vice President at the Mullings Group, shares how more than 20 years in medtech recruiting has shaped his purpose of helping people join companies and technologies that save and improve lives. Kirk explains why relationships and mentorship create opportunity, what a day in the life of a recruiter looks like, and how he stays current across diverse medtech areas while supporting single hires and multi-role team builds. He also offers practical guidance for candidates, from defining your “why” and career path to optimizing resumes and LinkedIn for how recruiters actually search and decide. Kirk reflects on lessons learned hiring for subcultures within organizations, the importance of legacy, and the joy he finds in family.    Guest links: https://www.linkedin.com/in/kirkpetyo/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 090 - Kirk Petyo Kirk Petyo [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Kirk Petyo. Kirk is an Executive Vice President at the Mullings Group with 20-plus years of experience in medtech talent, specializing in regulatory, clinical, quality, engineering, and commercial functions. His work spans both critical individual placements and strategic multi-role team builds across emerging technology companies, mid-cap organizations and strategics, turning organizational strategy into executable hiring outcomes. The Mullings Group has completed over 9,000 hires across 900-plus companies globally, playing a key role in building many of the most innovative medtech organizations in the market today. All right, Kirk, welcome to the show. I'm so glad that you are here today. Thanks for being here. [00:01:38] Kirk Petyo: Yeah, absolutely. Really excited. Thank you. [00:01:40] Lindsey Dinneen: Of course. I'd love if you would start off by sharing a little bit about yourself, your background, and what led you to medtech. [00:01:48] Kirk Petyo: Sure. Well, well, first of all, thanks again for, for having me. It's, it's great to have connections and how this circle of medtech kind of brings us together. And I'll probably get to that a little bit later in the show as we just talk about, you know, our connections and, and the relationships that we have. But, you know, I'm really lucky. I've, I've had the opportunity of spending roughly 22 years in recruiting with most of that being in the medtech space. And I started my career early working for one of the largest recruiting companies in the country, and that really r- set my roots into the foundation of the fundamentals, the character, the values that, that come from recruiting and really understanding the relationships that need to be built in order to be successful. And, and after going through that, I'm, I, I was part of a startup organization where I was a part owner, started up a medtech division of that, and there were some successes, there was definitely some failures, and some things that you learned along the way. And as we were kind of going through that, you know, I had the opportunity of meeting with Etienne Nichols. I worked with a company that that he had worked with. We were, we were given referrals and, and we were talking one day, and he's like, "You know, you, you gotta meet this guy, Joe Mullings, and e- everything that you're doing within medtech is exactly what they're doing and with five to 10 years in advance of, of where you're at. And I think it'd be just a great opportunity for you to, to spend some time with him." So I, I, I just feel really lucky and blessed that, you know, I get a chance to, to change people's lives, to put them in the opportunity and into the technologies that are, that are saving people's lives from startups to strategics and emerging technologies. And I, I couldn't be more excited about spending the next 20-plus years doing this. [00:03:32] Lindsey Dinneen: Oh, I love that. I love when somebody is passionate about what they're doing and clearly just feels like they are in the right place. So that's, that's wonderful to hear. Okay. So I'm curious, backing up a little bit, what got you into recruiting in the first place? Like, what interests and set of skills and things did you have where you were just like, "You know what? I think this all pieces together really well here"? [00:03:53] Kirk Petyo: Yeah, you'll, you'll probably hear this if you talk to a lot of recruiters that nobody ever says that "I'm going to get into recruiting." But I think that there's, I think that there's something there that it's, it's your, your ability to wanna, wanna do something and, and build relationships. And it's funny, i-if you look at my love languages I, I love a-acts of, acts of service, and I love helping people. If you talk to any of my friends, I'm the guy that's always, you know, trying to coordinate and, and get the guys together and, and I just love being able to, to impact people's lives in big or small ways. And I, I met somebody at a job fair randomly walked up and said, "I'm nervous. I don't know what I'm doing. I just wanna have a conversation. Do you mind talking?" And Marty Shager was the, was a gentleman, introduced me to a number of different people where I spent 17 years of the, of my the beginning of my career. And, and I think that was really the foundation of, I saw somebody that I could look up to, that I could admire, and when I started to meet the people that were here, I, I looked at, wow, all these people are motivated. They wanna make impacts. And I followed the leaders that, you know, I think eventually were just the, the, the groundwork for my career and my life. [00:05:11] Lindsey Dinneen: Yeah, so I'm sure we're gonna dive into this a lot because this is such a core thing about, you know, your job, but also who you are and how you kind of show up in the medtech space and beyond. And so relationship building is so critical, I think, to success in a lot of different areas of life. But I wonder if we could talk a little bit about the kinds of relationships that lead to opportunities, whether those are mentorships or things like that, but also-- we had a little bit of this conversation at MD&M West at a, at a dinner the night before with Etienne. And part of the topic that came up which was so interesting was this idea of surrounding yourself with good people, having really good conversations that go kind of beyond the surface level. And so I was wondering, really long-winded way of asking, could you share about your philosophy behind the importance of relationships, both personal and professional, to move the needle forward? [00:06:09] Kirk Petyo: Yeah, absolutely. Well, you know, you, you bring up a really great point, and I don't think that anyone has gotten to where they're at if they haven't had a group of individuals that was around them that was helping and supporting them. It's just you, you can't do it. And and I, I think that there's a great opportunity when you look at the relationships and the people that you spend time with, and does that really... how, how does that, how does that expand in your ecosystem? What are you utilizing from those individuals? And how are, how are you taking that information and making yourself a better person? And so when I, when I was working with someone like Etienne, I saw the value of his knowledge and experience, his, his, his tenure in medtech, his connection with, like, quality and QMS systems, and maybe an area where maybe I didn't have a lot of expertise or, or focus in understanding a third-party QMS system within medtech for maybe smaller... or I'm kind of giving a little plug here. Obviously that's not the point. But the, the, the point is, is that when you surround yourself with individuals, with relationships in, in areas that maybe you're an expert or try to be an expert in or to surround yourself with individuals that you can connect and connect the dots within the marketplace, I think that can be so powerful. [00:07:25] Lindsey Dinneen: Absolutely. Yeah, so okay. So I'd love to talk a little bit more about, okay, so what you do now and sort of, what is like a day in the life of Kirk like? [00:07:38] Kirk Petyo: So a day in the life of, of Kirk and a recruiter. Well, the day in the life of Kirk probably starts around 5:00. You know, it's a, it's a, it's a busy day, but it's, it's, it's full and impactful of, of a lot of things. You know, I I didn't get a chance to talk about it at the beginning, but I got two kids. They're 10 and 12. They're into sports. They, they love baseball, they love basketball, and they're in, they're in travel baseball right now. So it is, it is constant between them and games and things like that. But what you, what you bring into the, the workplace is there's, there's stuff going on every day, and your to-do list is never gonna get accomplished if you're really trying to make the impacts that you wanna make. What I, what I think is great about this job and, and what I do is I get an opportunity to find people roles in, in, in the opportunities that they really wanna get into and expand their lives. And we talking about becoming the person that you are and who do you wanna become. And so I get to have conversations daily with individuals that are trying to move their career in that out, in, in, in that retrospect. And so, I can be engaged in anywhere between 10 to 15 different projects. Could be single or multi-team builds. Could be in the cardiovascular neuromodulation, robotics, infusion pumps, CRM technology. It's, it's a wide, it's a wide range. So what I think is really fun but also challenging is that when I came here, I really had to focus on not just being a subject matter expert in maybe one or two buckets, maybe combination products or infusion pumps or Class 2 medical devices, is that you really have to be a subject matter expert in all aspects of medtech. And so one to two hours a day is just getting information and learning so that you can provide the best value to your clients. [00:09:26] Lindsey Dinneen: Wow. Yeah, that is quite the learning curve. And I, I would be curious to know, when you started going into medtech specifically, did you-- it sounds like you had, a-again, kind of a learning curve there. So what was that pathway like to, to really go, "Okay, I feel like I am in my happy place here," you know? Like, "I, I know recruiting's right for me, but, but here's this, this actual niche that's even maybe more right." [00:09:55] Kirk Petyo: Right. Yeah. Well, you know, I think there's a couple of things. The, the feeling that you get out of placing somebody is, is, is different than anything else in any other industry. And so people that aren't in recruiting just don't get it, sometimes. You know, w- and the fact of medtech is, you know, I'm placing people into companies that are really changing someone's life and impacting someone's life from dialysis to infusion to blood glucose monitoring systems. I mean, there's so many things that are involved in medtech that you're impacting somebody. But when you get, when you get into it and having the opportunity is, you know, it's, it's... In 2009, there was an opportunity that, that set to shift into more of an embedded hardware software systems focus. And that, I think, was the root of where my career started to shift and go into a little bit of aerospace, but really spending a lot of time in medtech because everything was transforming. Everything was becoming IoT connected. It had Bluetooth connectivity, and electronics were getting more and more popular. And I knew then that everything was gonna be connected in some aspects. And now you look at it and you think about AI, you think about digitization, there's so much that has gone on, I think that was definitely a right call. But you know, when I, when I think about medtech, I mean, if you think about recruiting in general, the, the industry has changed and the way you reach out to people has changed. The impact, how you treat an individual, and the journey that you take them on has changed. Because 20 years ago it was, "Why do you want this job? Tell me, tell me how much you need to make in order to take this job." And now there's more of a journey around that because we all have access to talent. [00:11:36] Lindsey Dinneen: Hmm. Yeah. Well, a- and that's great 'cause that segues really nicely into my next question, which is going to be about what are some of the lessons that you learned along the way? Perhaps things that went really well and you went, "Oh, wow, this is great," and things that maybe you thought, "Oh, well, maybe we're gonna, we're gonna, we're gonna take a different approach next time." I'll put it that way. [00:11:58] Kirk Petyo: Yeah. Well, y-you know, it's when you're building, when you're building teams, there's, there's gonna be a lot of mistakes along the way. And they could be small, hopefully not large mistakes. But if I, if I go back on my career, I can probably pinpoint, you know, 20, 30, 40 different mistakes that I've, that I've made that I think were, were, were challenges that eventually we overcame, but I think, you know, had a, had a, a, a good output at, at the end. One, one in particular was, we were, we were navigating an engagement with a, with a larger customer. This is, this is many years ago, and 50% of the company's population was over the age of 50. And so if you think about that in regards to the engineering team and the amount of IP and information that's gonna be going out of the organization, we needed to build out a team of individuals that was gonna be able to take that information, be able to learn from those leaders, and then be the future leaders of that company. Well, there's a lot of challenges that go in on that. And the, the success was that, you know, we ended up building out, you know, a team of 30 or 40 different folks that were, you know, in that tier one, tier two kinda level maybe four to five years out of college to, to really impact the organization. But the, the hard challenge on the front was really understanding what good looks like. Because for every manager, if you think about... I talk about this a lot, is you think about all of the subcultures within a culture within an organization, and they're massive. And so each group, each team is gonna identify things that are important to them that are different from what other people might be. And one of the mistakes that I learned along the way that I think has, has helped me later on in my career is that I looked at and I treat each role, each manager, and each subset as their own subculture. And so while a manager, you know, John, Doe, or Mary, might have one culture or one aspect of what they're looking for, that team that I'm hiring for might be unique in its own way, and I need to hire for that particular team and not be broad as if I'm, as if I'm hiring for the organization. So big, big learning moments in, in, in my career. [00:14:10] Lindsey Dinneen: Yeah. Okay. And, and I'm curious, do you have some particular advice for somebody who is interested in working with a recruiter but maybe hasn't before, maybe is a little nervous about that whole approach? What kinds of things are helpful for people to understand about the process? [00:14:32] Kirk Petyo: Well, y-you know, I think it depends on the, the recruiting firm that you go with and what that engagement looks like. I can give a big plug to the Mullings Group and what we're doing and how I think that we're the best in the market. But I, I think as you, as you go out there, there's a lot of different firms that you can engage with and, and I think you, you have to go into the situation understanding what you wanna get out of it, but you also wanna go into it understanding the why. So many times I talk to people about what it is that they wanna do and why they wanna do that, and typically there's a barrier there or there's a challenge there or there's a... There's something that is preventing them from really moving to the next step is because they don't know. And they'll say, "Well, I'm really open," or "I'm interested in a lot of different opportunities. I'm not really stuck on that one thing." Well, for me, I'm a recruiter talking to 100 to 150 people a week and navigating hundreds or thousands of resumes a week. Why am I gonna call you and what am I gonna call you about if I don't know what you want? And as simple as that is, is you have a purpose, and that purpose needs to be defined. And so my, my advice is for somebody that wants to work with a recruiter is to really sit down and understand, "What are the motivating factors that are important and critical for me as I move my career forward that are must-haves as I look at an opportunity? And then what is it that I want this recruiter to be able to do for me or with me as a partner to get access to the best roles in the industry?" [00:16:04] Lindsey Dinneen: So is it helpful to develop a purpose statement of sorts of just this kind of idea of "who I am at the core and what I want to do?" Or how--what would you recommend people do to approach that? [00:16:21] Kirk Petyo: Yeah. You know what? I think it's a really good question. We talk about it at the Mullings Group is, who do you wanna become? And it's interesting because while that wasn't my statement over the last, like, 20-plus years before I joined here, it was on the tip of my tongue of exactly feeling those same emotions. And so when I came here, I really believed in that. And so what I, what I think is I, I, I can break that down into a couple of different pieces. One is I think you really need to understand the person that you wanna become and where you are now, and what is your journey to potentially get there. I talked to someone the other day, and they're like, "I'm, I'm a VP of operations. I wanna move into a general manager role to move into a COO to eventually become a CEO." And they had their journey path pathed out. And then there's others that I talk to, and they're reacting based on the situation that the market is putting them in. Those people, while sometimes get impacted by layoffs or cutbacks or RIFs, that happens. However, how are you looking at your future? Which is probably one of the most important things that you do in your life is your career. You spend more time in your job than sometimes you do with your family. So one, you need to love it. You know, two, you need to have a purpose of where you want this to go and what does that path look like. Because when the market or something puts you in a situation, are you making the decision based on the, the, the where you're put at, or are you making the decision based on, you're in control and you're deciding the outcomes that you wanna have? Big, big difference, and I see a lot of people struggle with that. [00:18:04] Lindsey Dinneen: Yeah. Okay. Well, first of all, I love the concept of who do you wanna become, because I think part of ,part of what I love about it is there's so much built-in hope and optimism that not only is change possible, but you get to help decide the change. You get to decide who you wanna become. A- and so I have... i'm curious, you know, you mentioned it was sort of always on the tip of your tongue, so it, this had been, like, something that you've been mulling around for a while. Ha, no pun intended, but kind of. That was... [00:18:34] Kirk Petyo: Ha. That's good. [00:18:36] Lindsey Dinneen: And so I'm just... I, I'm curious, for you personally, do you have a purpose statement that you're kind of willing to share, even if it's maybe not... like, you seem extremely happy in your job and, and your career path, but just, I'm just curious. [00:18:54] Kirk Petyo: Yeah. You know, that's a, it's a, it's a really good --I think it's a really good question, and I think it really comes down to what was at my core. And when I was talking to Etienne and he said, "You have to meet with Joe Mullins," he was actually on the podcast the next day. And, and, and so I, I pinged Joe and, and we were having a conversation, and I told him that I was really interested in the opportunity. My big thing is I wanted to be a part of an organization that everybody was rowing in the same direction, who wanted to make an impact on medtech and wanted to be leaders in the industry. I wanted to, I wanted to partner with subject matter experts who were just as passionate about medtech as I was and really wanted to leave a legacy, which for me, legacy, I think is the most important thing in everything when you think about leadership, opportunity, growth, the person that you wanna become is really the, the legacy that you leave behind, both personally and professionally. And so, it was, it was all rowing in the same direction and making sure that I was with a team that wanted to make the same amount of impact that I did. [00:20:00] Lindsey Dinneen: Nice. I love that. And I, and I love that that's what you found. That is always a, an amazing thing. Okay, so, so another area that I'm, I am curious about is when you-- I, I'm sure you're seeing, you know, hundreds, thousands of resumes and LinkedIn profiles and whatnot on, on a daily basis, basically. But what are some tips that you might have for personal versus professional branding? I think that's a-- it's-- that's something that a, a lot of people have on their minds, especially with LinkedIn, where, you know, there's such a combination of both, you know, very sort of professional observations and commentary, and then there's, there's a trend towards e- being a little bit more personal and sort of raw and real about your life and things like that, and I'm curious what you see as being important and potentially, on the opposite side, not the best approach when you're evaluating candidates for that branding conundrum. [00:21:02] Kirk Petyo: Yeah. Well, you know, you can, you can probably break that up into two pieces. You can break it up into the resume standpoint and look at resumes first, and then you can look at LinkedIn. If I'm looking at resumes, typically that's a, a very professional type of setting. The, the thing that I think people need to remember is that a recruiter is looking at your resume within 13 seconds or less, is, is deciding whether or not they're going to spend time and whether their time is worth calling you or messaging you. That, that seems harsh in a lot of different aspects because you might have somebody that has 10, 20, 30, 40 years of experience, but we have to be able to identify whether or not it's worth our time to call you. And so making sure that it's... that you're using tools and AI and a lot of different information to best position yourself of who you are, what you've done, things that are important in that industry. And then for me-- this is maybe a quick tip for people-- is what are the buzzwords that someone is going to search or AI is going to use as a tool in order to look at your background to pull you to the top of the list? I can probably talk about that for an hour plus just in that specific topic, but, you know, I'll, I'll shift to the other aspect which you talked about LinkedIn. You know, I... This is my opinion and this is just my opinion from somebody who's been doing this for 20 years, and I may or may not have the, the answer that most people want, is LinkedIn is a representation of, of your professional career with a glimpse of your personal, your personal life. And I do think that it is important to show your authentic self. If, if you meet, if you meet me in person, I'm extremely outgoing. I'm very energetic. I'm bouncing off the walls, and that's who I am. I love spending time with my family. My family is the most important thing for me and spending time with my kids, going to every single baseball game, going to Purdue games. So you'll see that content. But you'll also see a lot of thought leadership about the market, the industry, where we're going, why we're going there. And there's people that post, I believe, on, you know, the, the, the, the basic fundamental topics that are out there, and then the ones that are really leading are the ones that are thinking about where are we going, how are we getting there, and what does the future look like? There's a big difference in that from... Yeah. So I'll, I'll, I'll leave it at that. And I, I... What I, what I think is a ba- maybe not a bad approach, but maybe a, a something just to think about is when you look at your LinkedIn page, does it reflect who you are, and does it reflect someone that is gonna wanna spend time with you on an opportunity to call you about a role within an organization? And you have to really look at it, not just as a personal thing, but as a business. [00:23:46] Lindsey Dinneen: Mm. So, okay. So thank you. That's great advice. I appreciate that. I, I-- it makes me think that it would be always helpful to have then your trusted mentor or frie- friend, but somebody who's gonna, you know, tell it to you straight. Like, "Hey, evaluate my LinkedIn. Do I come across the right way?" [00:24:04] Kirk Petyo: Nice. [00:24:06] Lindsey Dinneen: Yeah. That's awesome. [00:24:07] Kirk Petyo: Yeah, abs-absolutely [00:24:09] Lindsey Dinneen: Hey, s- this just circles right back. Relationships matter, and they can help in all sorts of ways. That's awesome. Okay. So, you know, I know you, you really felt like you, you found a lot of purpose in recruiting in medtech specifically, and you are impacting lives, and I'm wondering if there's any moments that stand out to you as really just affirming, "Wow, I am in the right place, in the right industry at the right time." [00:24:36] Kirk Petyo: Yeah. You know, it's, I, I, I'll tell you that getting some of the messages from people that say, "Kirk, this was the best experience that I've ever had," is, is really impactful. And I'm words of affirmation, kinda going back to the love languages. So, that's, that's my second piece is I'm, I'm a words of affirmation guy. So being able to hear from the marketplace that I've impacted their lives in a way that is more than just money, but about the purpose that is driven in them, segue back into the what is your why, right? So if I know your why, I know what to impact you on, I know what calling you about the right opportunities is. And it's, it's interesting because when I talk to a lot of people, when I was in recruiting 10, 15 years ago, it was kinda like if you had an opportunity, you're like, "Why, wh-why are you interviewing somewhere else? Like, what, what, why are you going after that role?" For me, I would love for you to have five or 10 different interviews. And you know why? Because it is my job to make sure that that why is hit, that that purpose is hit. And so that when an opportunity does come up, and I do find you that role, and you interview, and you get that job, and you take that job versus the four others, that's when I know that I did my job correctly, and that, for me, is a lot of the gratification that I need. I love hearing shout-outs from clients. I love hearing shout-outs from, from individuals that we impact in their lives. But I don't think there's any particular moment. But I, I, I will say that the, the last 20-plus years in doing this, hiring over 1,000, maybe 1,500 people in my lifetime I cannot thank enough of, of, of the individuals that I've had a chance to be a part of their journey. [00:26:18] Lindsey Dinneen: That's awesome. That's super cool. What a, what a gift. So not only are you in the right place at the right time, but you're also getting to help your clients do the same. That is, that is, oh, that is cool. Yeah. [00:26:32] Kirk Petyo: Thank you. [00:26:33] Lindsey Dinneen: Yeah. Okay. Well, this has been a fantastic conversation, but I also would love to pivot it just for a moment for fun. So. [00:26:43] Kirk Petyo: Okay. [00:26:44] Lindsey Dinneen: All right, imagine that you were to be offered a million dollars to teach a master class on anything you want. Could be within your industry, but it doesn't have to be. What would you choose to teach? [00:26:56] Kirk Petyo: Anything in my industry or anything in my personal life that I would wanna teach. You know, it's The, the first thing that probably comes to mind is, is maybe baseball or maybe golf or fishing. Love to take my kids fishing and, and spend time with them. You know what? It's... I-if I had an opportunity to do something like that, I, I would... I think I would really wanna do something that I've never really done before, and just spend a ton of time just learning and digesting as much as I could to, to, to try to give a presentation on a topic. It's, it's... I had a friend that and, and a CEO of a, of a pretty big recruitment firm that was recently on a TED Talk, and the amount of time and effort it put for him to put into that--just learning so much and spending so much time, I think that would be so much fun to do something like that. And I was in a heavy metal band. I was lead singer, so I love being up on stage. And so I think if I had an opportunity, I would just love to invest time and effort and to do something like that one day. [00:27:55] Lindsey Dinneen: That's awesome. Oh, I'm-- [00:27:57] Kirk Petyo: Now that's another topic for another show. Karaoke, heavy metal, being on stage. Yeah, that's, that's a different, that's a different podcast, but, you know, we can pick that up another time. [00:28:07] Lindsey Dinneen: I, you know, I, I actually have that other podcast. It's, it's currently on hiatus, but it's called Artfully Told, and it's about people sharing their experiences with art. So we'll have to reconnect about that. [00:28:17] Kirk Petyo: Right, there we go. Art-- music is art. Yeah, I love it. [00:28:20] Lindsey Dinneen: Oh my gosh. Okay. And how do you wish to be remembered after you leave this world? [00:28:27] Kirk Petyo: Yeah, I mean, that's easy. It's, it's, it's for me, it's all about legacy. I, and I, I break it into two pieces. It's, it's, for me, it's a legacy of my family and my, you know, my kids and, you know, what my parents and my dad and his dad have left left for me and, and the legacy that I wanna have for, for, for my family in the future. I think that's, I think that's what it's all about. I talk a lot about legacy, so for me that's an easy answer. And then in the professional life is, you know, just the impacts and the people that I get a chance to meet with and, you know, having leaders that have impacted me and made me the person that I am today, and if it wasn't for them to say something when they needed to say something or pull me in when they needed to pull me in, I, I wouldn't be here and I wouldn't have this opportunity. And so it's my job to continue to pay that forward, and I wanna be known for that guy that's, that has that gratitude and will continue to pay it forward no matter what. [00:29:19] Lindsey Dinneen: Love that. Oh, I love that. Okay, and then final question: what is one, what is one thing that makes you smile every time you see or think about it? [00:29:30] Kirk Petyo: Yeah. It, you know, it has to be my kids. You know, I you know, I'm a, I'm an emotional guy, and so you probably could've got me a little emotional on this, on this conversation. But I, I promise I'll, I'll hold it together. No, I love spending time with my kids. I love watching them play sports, and right now they're in travel and Little League. They play both, and I just won't miss a game. I won't miss a game for golf. I won't miss a game for travel. I will do everything I can in order to be at those games. We have two tonight. I have to separate and figure out which one I gotta go to. But I, I... Every time I see my kids in, in a setting where I see them, it just, it brings a smile to my face [00:30:06] Lindsey Dinneen: Very nice. I love it. Well, Kirk, this has been an amazing conversation. I so appreciate you sharing your experience, your expertise, your advice with us, and just giving us some really practical tips and tricks along the way. So thank you so much for everything that you're doing. And we are honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support. Thank you for being a part of an industry that is, you know, making an impact, and thank you for working hard to change lives for a better world. [00:30:56] Kirk Petyo: Yeah. Thanks for a great interview. This was so much fun. Thank you. [00:30:59] Lindsey Dinneen: Of course. [00:31:01] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Stephanie Rupp (Hoffmann Eitle) and Ryan Phelan (Marshall Gerstein) explore how AI is reshaping medtech innovation and the IP strategies founders need to know. They break down key trends, from traditional model training to today’s generative AI workflows, plus common pitfalls like novelty-destroying disclosures in pitch decks, websites, and investor conversations. Ryan explains why “file early” matters in the U.S. (and how provisional applications can backfire if they’re too thin), while Stephanie shares how Europe’s strict novelty rules and EPO “technical effect” requirements change how AI patents must be drafted. The conversation also covers cross-border collaboration, the Unified Patent Court, and why strong IP can become a startup’s moat for investors and future growth. Guest links: https://www.marshallip.com | https://www.hoffmanneitle.com/ | [email protected] | [email protected]  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 089 - Stephanie Rupp & Ryan Phelan [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.  Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guests Stephanie Rupp and Ryan Phelan. Stephanie's technical expertise stems from working in various fields of electrical engineering and information technology. She is particularly interested and experienced in communication technology, telecommunications engineering, and artificial intelligence due to her time at the university and various projects in the industry. For example, Stephanie gained industry experience with a leading technology company of measurement and high-frequency technology in the field of measurement technology for LTE. Working with a variety of clients from all over the world, Stephanie specializes in prosecution and oppositions at the European Patent Office and German Patent Office, freedom to operate, and patent drafting, in particular in the fields of computer-implemented inventions. Stephanie studied electrical engineering at the Technical University of Munich. She wrote her master thesis at the Chair of Communication Networks in the field of artificial intelligence with a focus on reinforcement learning. Ryan is a registered patent attorney who counsels and works with clients in all areas of intellectual property with a focus on patents. Clients enjoy Ryan's business-focused approach to IP. With an MBA from Northwestern's Kellogg School of Management, Ryan works with clients to achieve their business objectives, including developing and protecting their innovations and businesses with IP. Ryan has been published in several well-known IP publications, including World Intellectual Property Review, Bloomberg Law, and IP Litigator, and has spoken as a panelist at various IP conferences, including for the International Intellectual Property Law Association and for the University of Illinois Chicago Annual IP Conference. Since 2024, Ryan has been selected for inclusion in The Best Lawyers in America list in the practice of patent law. All right, Ryan and Stephanie, welcome to the show. I'm so glad that you are here. Ryan, this is your second time. Delighted to have you return, and Stephanie, I can't wait to learn more about you and all the ways that you both contribute to the industry. So thank you both so much for being here. [00:02:54] Ryan Phelan: Yeah, thank you. Yeah. Glad to be back. [00:02:56] Lindsey Dinneen: Awesome. [00:02:56] Stephanie Rupp: And thank you v- very much for having me. [00:02:58] Lindsey Dinneen: Yes, of course. Well, I would love, if you don't mind, starting off by sharing just a little bit about yourself, your background, and what led you to medtech. [00:03:09] Ryan Phelan: Yeah. So I'll kick it off. My name's Ryan Phelan. I'm a partner at Marshall Gerstein, which is an IP boutique here in Chicago. I have a computer science background, so I see the world through, you know, everything computers and, of course, nowadays that means AI. On the, the medtech side you know, I, I have, experience in robotics and so, a lot of medtech devices are in the robotics field, so it's very natural for me to apply my skill set, to that, area of expertise, one of which is, prosthetics. So you have a robotic, prosthetic medical device, and that lends itself to, you know, some type of computational control. And there's certain, legal issues that usually come up in, the US practice. So I enjoy, applying that skill set, to the, to medtech space. also, you know, family members als- have, you know, ailments and things that, I have, grown up with, you know, as a, you know, young boy and, now I'm very happy to you know, give back in my own way. I'm not a doctor. I'm just a-- I'm a, I'm a humble patent attorney, but, helping the, IP world, and, doctors and physicians, with not only, you know, in the robotic space, but also, software medical inventions as well, and I, enjoy working in this space. [00:04:22] Lindsey Dinneen: Love it. Thank you so much. Stephanie? [00:04:26] Stephanie Rupp: Yes. So as you hear from my accent, I'm from Germany, specifically from Munich, so that's a city in the southern part of Germany, close to the Alps. people might probably know Munich from the Oktoberfest that we have each year. And, so I'm a German and European patent attorney at Hoffmann Etile. I also throw it in as well, I'm also UPC representative, so we have, for three years now, we have the Unified Patent Court, so a really new court in Europe for centralized litigation for infringement and revocation actions. So I can also represent clients there. yeah, Hoffmann Etile is a, also a p- a IP boutique firm. not only in Germany, we also have offices, in other places in, Europe. And, yeah, my technical background is electrical engineering and information technology. And, during my studies, I just didn't work a lot in the medtech space. I was, ... my work concentrated more on the telecommunications side, working in a, bigger f- company that, concentrated on measurement and high-frequency technology. But, my master thesis was already about AI, so it was at the Chair of Communication Networks, and it was about, like, reinforcement learning, virtual network embedding. I won't say too much about that. I think it will bore the listeners. But so I didn't know at that time, but it opened my way to the medtech space afterwards. because when I joined Hoffmann Etile nine years ago with my training, the partners were really happy to hear that I have experience in the AI field and the technical background on that. And, around nine years ago, we saw a lot of patent applications being filed in the AI space, like using AI technology in different technical fields, and especially also in the medtech, field. And, so I had the opportunity to jump in there, like, right away when I started and was really happy to do that and also, like, still very glad to have that opportunity to work with the medtech, companies and to get the best patents for them in that, especially in that field. [00:06:26] Lindsey Dinneen: Awesome. Thank you so much. Yeah, thank you both. So, all right. I have so many questions, but I will start here. I'll just, 'cause I'm curious. So how, how did you two meet? Do the firms come together and, and, collaborate? [00:06:38] Ryan Phelan: Yeah, absolutely. so Marshall, Gerstein and Hoffmann, Eitel had a relationship prior with, attorneys, that go back a generation or two, before Stephanie and I met. And so, their-- one firm would send attorneys to the other and vice versa. And then, after a while, given that Stephanie and I have similar backgrounds, it was very, simple just to connect us. And then we've worked together on matters, before and have similar backgrounds like Stephanie mentioned. She has electrical background, but has done a lot of stuff with AI. And so whenever you're doing, matters across the pond, as they say, you need expertise, in the EPO and the US and the laws are different, so you have to collaborate. And it's great to have, have people that you can collaborate and work with. [00:07:21] Stephanie Rupp: Yeah, and a lot of clients, they're not only interested in getting an EP patent, but they also want to get a US patent. And, I'm not a US patent attorney, so, usually tell them, "Oh, yeah, I know a really good patent attorney in the US." And, thank you ... so I will, like, hand over the work to him and then the other way around if they have, like, clients that they want to get a EP patent, and that's how we work together and, also dis-discuss these cases together. And, so yeah, I'm currently in Chicago for a week, also to meet Ryan in person again. I do that, usually once a year. And, yeah, just have time to discuss some cases more regularly. [00:07:55] Lindsey Dinneen: I love that. That's cool. [00:07:56] Ryan Phelan: Yeah, I was in, And I was in beautiful Munich last year, so it was, it was great. [00:08:00] Lindsey Dinneen: Very nice. That's wonderful. Okay. So again, so many things to talk about, but I, I, I'm curious in your interpretation of how AI has affected, especially the legal components of, say, filing a patent or IP protection or all of those things. When it comes to medtech founders, what are you seeing the trends to be, and also, what are some of the pitfalls to avoid? [00:08:29] Ryan Phelan: Yeah. So I've seen AI affect everything from filing strategy or information, gathering, like on the pre-stage of a patent, and then also, the invention itself, has also included AI. I think about it as like AI 1.0 and 2.0. before, 1.0 AI is, a lot of software inventions would train their own models with their own data. Maybe you have a, a cardio, application or something like that, that would use existing, information from patients and, that information, would be used to train a model, and that model would be able to output some type of response for a future patient. Maybe that model was inside of a device that was, implanted or, put on top of, a patient where that sensor data would be collected.  Nowadays, in, in tho-those inventions, usually incorporated some type of trained model. Nowadays, you have a lot of generative AI, where newer inventions are using out-of-the-box models from OpenAI, ChatGPT models, or Anthropic's Claude models. And, a lot of the same issues are still being addressed, where data will, will come from various sources, whether it's a patient's data or clinician's, or maybe it's, a diagnostics or maybe it is more in the robotic space for, prosthetics. But that data is now, instead of being pushed into more traditional models that would be trained, is now being used by these generative, LLMs. And then you can have combinations of the two. So it's, become an explosive field in AI at least from what I have seen. People are getting excited that you have these large treasure troves of data that you can synthesize, the information inside of it and then get some type of, useful output, and then you also have inventors that are seeking solutions, asking, LLMs to help find a particular solution, and they'll add to it. And our invention disclosures that we get, I, I typically joke and say, "Used to, it was hard to get an invention disclosure from an inventor." They would send you, like, a paragraph or two of the invention, and you'd be, "Well, is there anything else?" And now it's, they'll send you 100 pages of stuff. And like, "Well, let's, well, let's talk about what's relevant. Let's find the needle in the haystack here." So AI is, is influencing all sides of the invention from when it's coming in the door and then how, how, what the invention makeup is itself and how that's gonna be protected in the future. I, I see a lot-- In, in the future, I, I can predict or hopefully predict, there's gonna be, a lot of litigation or a lot of, like, questions about who owned what in the future for patents. So that's, that'll be interesting to see, too. [00:11:06] Lindsey Dinneen: Yeah. Absolutely. [00:11:07] Stephanie Rupp: Yeah- I think what I just want to add is, that it also changes how we work. I think in the past it was, so we had, like, these different departments. We had mechanics, e-tech, biotech, chemistry, and it was, like, very clear when you get a new patent, like an invention disclosure in which department you will push it and, like, who will work on that. But now we have, like, more these interdisciplinary inventions especially, like, in medtech, pharmaceutical companies that are using AI and, and that also changes how we work, that we are trying to then find a interdisciplinary team as well, having, like, patent attorneys from different technical backgrounds, because I'm looking at a invention disclosure differently than a patent attorney with a chemistry background. And, so that makes very interesting for us as well, 'cause we have to work together and, that's why sometime I get a call from the biotech department saying, "Oh, we have a invention disclosure with a lot of AI in there. Could you maybe help us out?" And, so that, yeah, it, like, changes our way of working in there as well. That makes it very interesting. [00:12:12] Lindsey Dinneen: Yeah. That's very interesting, and I actually love that. It seems like a lot of, ability to learn from each other in that way, and so yeah, I love that exposure. So, okay, when it comes to filing patents, and protecting your IP in general, I'm, I'm curious what your advice is for, for founders that maybe have, like, basically timeline, when should they be thinking about engaging with you all, and h- how do they go about that? Just what is, especially for these younger startup founders, what's some advice that you just, you go, "Okay, now's the time. Here's what we need," and, and whatnot? [00:12:51] Ryan Phelan: Yeah, I always advise as early as possible. Okay. usually it's-- usually most founders or startups are not thinking about patents in the beginning. But, you know, I always like to, to tell them when, when I'm speaking to a founder of a startup, think about it as insurance or similar to insurance, because at the end of the day, if you become very successful with your, medtech product, whatever it may be, people are gonna wanna copy you. [00:13:13] Lindsey Dinneen: Yeah. [00:13:13] Ryan Phelan: And, that, that's probably not only important to you, but also to your investors, if you have them. If, like, you're seeking money from others, whether it be seed money, angel money, or series A, series B the, these people are probably gonna ask you what's your moat, what's your, what's your barrier to entry for others, so if your product, takes off, because they're thinking in terms of, "How much money will I get back if I invest?" It's gonna be s- 20x. And so, it-- they know, and the startup founders should also be aware that if somebody else comes into the market, especially a big player, and they, replicate your product or your software, then that could take market share from you. And so having a patent or building that patent portfolio at the same time, it protects you, from that. It also, of course, there's times, timing, that you have to be mindful of. As soon as you disclose something in the US, it kicks off a, a one-year clock... [00:14:04] Lindsey Dinneen: Hmm ... [00:14:04] Ryan Phelan: ...for you to file something. Just to get an invention in the US, and Stephanie, can let you know about, you know, elsewhere- Mm-hmm ... and in the EU, I understand that there's an absolute bar. Yeah. But for that reasons, for that timing purpose of when someone discloses your invention, and that can be a part of a pitch deck to a set of in- investors, if you don't have a non-disclosure a- agreement, an NDA, then that could also start that clock ticking. So you wanna be mindful. Do this in parallel at the same time, seeking to get your, patent, at least a provisional patent, on file before you go forward. [00:14:37] Stephanie Rupp: Okay. Yeah, as Ryan said, at the, in Europe, we don't have this kind of this year to file a application. Once you publish something, then it's out on, out there in the world and, endangers your own patent application. Because if you want to get a patent the claimed subject matter needs to be novel and inventive. And if you have, like, published this before, then that's prior art with respect to your own patent application. So you always have to keep that in mind and, that's why it's so important to file the patent application first before you use that information for advertisement, for example. And I, we see that often, with startups, and I complete- completely understand. They're super excited with regard to their, like, great idea, and they want to shout it out to the world. But once it's out there that hinders you to get a patent. so- As Ryan said, it's good to think about patents from the beginning and also, the market you're interested in, maybe about competitors and where they're in, which countries they're involved, and then you could also think about, okay, maybe, that is a market of your interest, and then also get advice from patent attorneys in that country because it's different from which d- like, from jurisdiction to jurisdiction how to get a patent, and you want to get the broadest patent as possible. And, especially with AI inventions, where they're the requirements are so different in the different countries, it's, good to have the advice from the beginning on so the patent application is written in the right way. Because once the patent application is filed, we cannot add anything anymore, or we cannot change it. That's why it's, like, good to have really a, like, a well-written patent application also for the jurisdiction you want to go in. [00:16:25] Lindsey Dinneen: Okay. Yeah. Thank you both. That was really insightful. I'm, I'm curious about the patent application itself. Is there-- Well, two questions, I suppose. Is there also a kind of provisional patent opportunity outside of the US, just out of curiosity, as, as well as in the US? And then also, you know, you mentioned being very careful and cognizant about the way that it is written, which of course now you two being experts in this, you know, back, you know, like the back of your hand. But I wonder, if people try to do it themselves. I would love just to hear some advice about that as well. [00:17:06] Ryan Phelan: Yes. Stephanie, do you wanna talk about the provisional outside the US and- [00:17:09] Stephanie Rupp: Yeah. So in Europe, we don't have that provisional applications or non-provisional applications. what you have though is the priority year. So you can, like file an application, for example, first in Europe, and then you have a year to decide which other countries you want to go to, and then claim priority from that European patent application. So, I file a EP application, then after a year I think, okay, I want to go in other countries, I want to maybe file it, one in the US, then you can claim the priority from there. And the previous patent application that you filed will not endanger the other patent application. So that's one way of doing it, to buying yourself a little bit of time. Also, sometimes clients when they're like very cost sensitive, especially for startups, would first think, okay, we file a patent application first to Europe, and you get a, a search report within the priority year from the EPO. And then you already know the prior art that is out there, and you can assess how strong your patent application is, and then you can still decide, how to proceed from there. So there are like some ways of how you could do that. [00:18:19] Lindsey Dinneen: Awesome. Thank you. [00:18:22] Ryan Phelan: Yeah. In the US, of course, we have provisional applications. It, it causes a great, amount of confusion, though, the provisional applications. A lot of startup companies will think that they can file a provisional application and it'll be, you know, a page or two in length, and then they can wait a year and inflate that to 20 pages or, or something like this. And of course, the, the trap for the unwary is, of course, if the claims, when you draft those for the non-provisional or the conversion application, if they are not grounded in that first provisional application, if one element of one of the independent claims, for example, is, s- solely supported by the new material added in the, the new, you know, 20 pages or whatever it may be, then the support gets you the date of your non-provisional conversion filing and not of the provisional. So, usually for startup clients, I have to-- we ta- we have this conversation called the delta. What's the delta between your provisional and your non-provisional? If there's a lot of it, then, that could be a problem because if your claims aren't supported by the text of that provisional application, you're not gonna get that original date. And so, usually that kicks off a conversation of how much of a provisional that you want, or do you just wanna go all non-provisional. Now, I do litigation as well, and I can tell you, the, the, the pitfall is if you file that provisional and you file a non-provisional later and you end up getting that later date, if there is intervening prior art in between, the provisional date and the non-provisional date, that comes before your non-provisional date, that could invalidate your patent despite your provisional. And there's, parties debate this. They, excuse me, fight about this in court all the time. Now, did you have sufficient written description and enablement in your provisional application in order to substantiate your claims later? And if they can find intervening prior art between that year or whatever the time may be, that can be a real problem. So, I, I always c- I always tell clients, like, the, the more you can file up front, the better, because you're gonna get more support or more, possibility to have that support earlier in time. Of course, it takes more work. Most startups don't like to hear that, but it is, but it is the truth, and it does, it does protect them against that insurance policy. You, you add it up front. Like Stephanie said, you wanna, put that information, on file before you go out and do your advertising and marketing. That's also true in the US. Just filing a provisional application, does not in and of itself somehow protect you if, if you don't, if you don't say what it is that you're trying to protect. [00:20:48] Lindsey Dinneen: Yeah. Okay. That makes a lot of sense, and thank you so much for that insight. So you mentioned a couple of times that sort of disclosure component, and so just to d- just be very specific about that whole thing you mentioned that could be-- that could look like even just a, a pitch deck where you think it's potentially within a, a private setting thing. Of course, I would imagine that also extends to talking about it on social media or a website or something like that. So I'm just curious what are some of the things that you see besides maybe perhaps the broader, more obvious, like a website, what are some of those things that you see that people don't think to, be aware of, I guess? [00:21:34] Ryan Phelan: Yeah. I've seen websites. It's super easy to create a website nowadays. You can ask ChatGPT or Claude to generate a website, and if you're putting your invention out in a website form before you file a patent, that could be a novelty-destroying disclosure. if you have a detailed pitch deck that you give to, potential investors without some type of control, like an NDA, that could also be a novelty form of disclosure. Like in the US, for litigation, I, I can tell you one of the questions that always gets asked in discovery is, "Did you disclose this prior to the, the filing date?" And, if that person, that person will be required to answer under oath, and if they're, "Yes, I had a website," or, "I, I gave this pitch deck to 50 people for investing," usually that's a problem because that--the opposing side that's defending against that patent will do a, a deep analysis and, and look-- and try to find when that was disclosed, and does it map up to the claims, and that could, create a problem with, validity in the US. [00:22:31] Lindsey Dinneen: Oof. That's no fun. That's why they should talk- Yeah ... to you early and often. [00:22:37] Ryan Phelan: Yeah. Yes. Again, another example of filing early, you know, eliminates some of those issues. i-in fact, I tell a lot of the startup companies or any, any client, like, before you go out there and, you know, have your conference or your, your pitch, then file. Most sophisticated clients know this, but a lot of times startups do not. [00:22:54] Lindsey Dinneen: Sure. Yeah, and if you're a first-time founder or something like that, you wouldn't-- you don't know what you don't know for many different categories, so I can see why that is so critical. Yeah. Okay. So, I was wondering if both of you could talk a little bit about maybe, maybe a moment that has stood out to you as, as you've worked, especially with-within medtech and, and working with some of these founders. Are there any moments that really stand out as just affirming that, "Wow, I, I am doing the right thing in the right industry at the right time"? [00:23:28] Stephanie Rupp: Shall I start? Yeah. yes, I, I've-- So for me it was, like, never the plan to become a patent attorney and, and, like, never had that in mind. And, so it was more of a coincidence that I stumbled upon that and did the training and became a patent attorney and... But I still remember my first day in the office and having the feeling of, "Yes, I think that's what I want to do for the rest of my life." Like, continue learning, like, having, like, this incredible opportunity to speak with so many great inventors. Having, like, I don't know, it's always amazing, to see how their mind works and that they're, like, finding solutions for s- like, very complex problems. And, so that, like, from the day, first day on, I had, like, the feeling, okay, I think I can really help here and, protect their asset the best way possible. And then especially within the medtech field, I think what Ryan also said in the beginning, there's like, it's also for me, sometimes it's a kind of s- scary part thinking about, okay, what if you get sick at one point, or like from closer family that got really sick, and, having like this helpless feeling like that you maybe can't change anything here. And then when you work with the medtech industry and you see that they are working on that problem and have these great idea- to help people to like, that there's also k- some kind of involvem- like involvement in this technology. And, so for example, I, there's like one of my clients, they are, working on histological images and analyzing them also with respect to cancer types, and how AI can be such a great help there. And of course, there are like a lot of these discussions about, how we should be careful with the new technology and how we could re- regulate that and stuff like that, but there's also like so much good in there that can really help people's lives. And I think that's like for me, always very nice that yes, Ryan said we're no doctors. So like, we're just like patent attorneys, but still we could contribute a little bit to that too. Yeah. [00:25:34] Lindsey Dinneen: Love it. [00:25:35] Ryan Phelan: Yeah. I would just, I would just echo everything that Stephanie said. That certainly is why I enjoy working in this space too, is, you, you feel like you have a, a little bit of contribution that you make. [00:25:44] Lindsey Dinneen: Yeah. Absolutely. I, I couldn't agree more. I think, to your point, Stephanie, it's, it's so inspiring to see the innovation that's coming out, and it makes you feel like, especially when there's difficult world news, it makes you think, "Okay, but at least there are still these change makers who are really trying to make the world a better place and, and improve patient lives." And I think that's just a, a wonderful thing to get to witness and be a, a part of. It helps the soul. So, I'm always curious about the personal side of things as well. So just what are, what are some of the things that you all en- enjoy doing, say, outside of work? maybe some hobbies or volunteering or interests and things like that. What are... Let's, let's talk about the people as well behind these amazing patent attorneys. [00:26:36] Ryan Phelan: Yeah. everybody has a hobby, so I, I was, I like to run. I was running since high school, so I like to do that. And then, in the winter I like to ski. and then I'm, recently getting my scuba cert, with my daughter. So we're having a good time doing that this summer. So just trying to stay busy and active. I like to learn always, and so I, I, I love learning, I guess. and one of the reason why medtech is interesting to me 'cause I like to apply that, computer science skill to, the medtech field and continuously learn, in that space and also give back, like we talked about before. So, yeah, I guess I would lump in learning as one of my hobbies as well. I like... I, I'll say, and I, I'm not sure if we'll get into this later I think you had a question about, poss- if we, if we could teach one class or- No, we'll get into that ... [00:27:20] Lindsey Dinneen: Something like that. Yeah. [00:27:22] Ryan Phelan: Yeah, okay. I'll, I'll save that for a later time. So. [00:27:23] Lindsey Dinneen: Okay. Yes. Excellent. Stephanie? [00:27:28] Stephanie Rupp: Yeah, I think that's, one common thing that we have, Ryan and I. It's, skiing. That's also what I enjoy a lot. so as I said, I'm from Munich, and it's very close to the Alps, so it takes us only, like, about, like, two hours to go to Austria. and so, but I really enjoy going there for the weekend, clearing my mind. Yeah, especially when the week was very busy with work. so it's like, thinking about something else. And, besides that, yeah, spending time outside, going hiking at the weekend, like when it's... there's no snow. Also, I picked up some hobbies that I had when I was younger. So for example, I had, piano classes for, like, when I was five years old, and then once I had, like, the training and everything else going on, paused that because, like, so much else going on. But then last few years I, taught myself, "Oh yeah, it would be such a waste not to do that anymore." And, so I'm, like, started playing piano again. I'm not good in it. It's more really as a hobby. And, but yeah doing something else in the evening and clearing my mind. So that's what I usually like to do as well. [00:28:35] Lindsey Dinneen: I love that. That's wonderful. I, yes, I, I understand that sometimes picking up a hobby that you sort of set aside for a while is really fun as an adult, 'cause you have a different way of interpreting that learning, back to your point, Ryan, of how it, it it changes. And I, I actually really enjoy that, of, of revisiting something where I might have thought g- especially growing up. Like for instance, I remember thinking I just could not paint for the life of me, like it was never gonna happen. And then as an adult, with a, an instructor who was... maybe s- spoke a slightly different, in a different way, and then getting to like go, "Oh, maybe I can" is always a nice thing to learn too. But anyway. [00:29:17] Stephanie Rupp: And also taking, taking the pressure out of it. Yes. So it's like, as I said, like piano class is just a hobby. I don't have to be good in it. It's just should give me some joy in it. And so yeah. [00:29:27] Lindsey Dinneen: Love that. Yeah. Yeah, okay. So now you've both been in positions of leadership, and I'm curious, and, and I know it's hard to boil it down to maybe one thing, but what is one or two, three things that you would say is your top leadership advice, especially for those who maybe are more in, middle management trying to continue to build their leadership skills? And what, what makes a good leader, in your mind, and then maybe what's one or two pieces of advice? [00:30:02] Ryan Phelan: Yeah. What makes a good leader in my mind is something that somebody that can lead by example, I guess. On like a first project or a new client or a new matter, I like to do it, do it myself once so I can go through it and, get the feeling for the new technology, that may be at play or the new matter, maybe the client's preferences whether it's a startup or a large company. And then once I have that kind of lead from the front, then I like to do, I guess, a military word, dis- decentralized command, which is get people that I trust and who I have a great assistant. I have attorneys that I work with European attorneys such as Stephanie, and then give them work with them and give them free reign and control, whether it's a colleague like Stephanie or a associate here at Marshall Gerstein to, work with the client or have agency over, what they do, 'cause I think it can also teach in that capacity, like things that I learned from the lead from the front can flow, down or through or out and then, that person can also learn on the job doing it themselves. I believe that, people doing, instead of just listening is the, a best way to learn for them and then also get better. And so I, I tend to approach, leadership, from that perspective. [00:31:12] Lindsey Dinneen: Love that. Yeah. Stephanie? [00:31:15] Stephanie Rupp: Yes. I see myself like still more at the beginning of my career, so I can, talk a little bit more of how I, see or like, yeah, see leadership or like, how I experience it. Yeah. it's more also I... like everything what Ryan said, I completely agree. And also like seeing the person behind that. It's like everyone is like very busy, especially when you're in leadership positions and, very busy schedules and, But also seeing the person as a whole- Mm ... and how could you like support them to be better, to grow and, how to also, yeah- lead them or like, yeah, lead them in the way they w- where they want to be at some point. And, I think that's, yeah, what you should not forget e- especially when you have a really busy schedule. That's it. [00:32:11] Lindsey Dinneen: Yeah. The, the person behind... Yeah. That, that's an interesting theme that continues to come up, time and time again, is, you know, if one of the tricks to being a good leader is to care. It seems so straightforward, but it's if you care about the person and you, you want the best for them, you are going to naturally be a better leader because you're investing in them and, and in their success and goals, and, it's, it's just cool to see. Okay, and then, all right, I'm just going to pivot the conversation a little bit for fun, and this is where exactly what you were referring to earlier, Ryan. So if you were to be offered a million dollars to teach a master class on anything you want, could be in your industry, but doesn't have to be, what would you choose to teach? [00:32:58] Ryan Phelan: I would teach a class called Patenting Software Inventions and, I'm actually currently teaching that class. Oh. they're not-- I'm not getting paid a million dollars to do it, unfortunately. [00:33:07] Lindsey Dinneen: Dang. [00:33:07] Ryan Phelan: But, but it is a, a, a passion and a love. I teach it at, Northwestern Law, where I went to law school. I-- it's, it's my pleasure and joy every year to go back. I teach a power course there every year, I think for the past eight years on, teaching students how to patent software inventions in the US, and I think, elsewhere there's a, you know, there has become, by at least some people, the belief that you can't patent software, you know, which of course is, not true. And so, you know, I teach methodologies in my class about how to, patent software inventions in the US using you know, guidance from the courts, from the Supreme Court, from the Federal Circuit, from the district courts here, in the US. A lot of it covers, things such as Section 101 you know, that changed, in 2014, from the Supreme Court's decision in Alice v. CLS, and how to address, issues, about what the, the court said there. And then also what later courts, the Federal Circuit, said that they wanted to see in order to overcome, Section 101 issues, in the US. A lot of times, too, it's interesting, we have, like, a small slide like that, that deals with EPO-- which Stephanie's much more adept than, than I am-- but what we tell our students is, and maybe Stephanie can address this, is that, you know, there seems to be a convergence, between Section 101 law and, something called a technical effect, an EPO, where it seems like both jurisdictions are wanting to see more of a technical disclosure incorporated into the application rather than just kind of claiming functionally or a high level language. So you need to be very careful in crafting these applications so there's-- they're successful when you're in front of the the patent office in the US. And if you, you do it right, you can, create, you know, not only a US-centric application, but one that might, withstand, the strictures of the EPO. In my opinion, I think that the EPO can sometimes-- and maybe this is just me being a US practitioner-- but the EPO can be somewhat more difficult, to get a patent, application. Maybe Stephanie would disagree and say it's the other way around, but but it's always good, and clients usually, even if they're not thinking about it, to have an application that could survive both places 'cause they tend to be, I think, the, the two more, more difficult, if not most difficult jurisdictions in the world to get a patent application. And if you go into it knowing and how to craft a patent application and you're ready, and you put into that application the right, material, then you can be successful. [00:35:40] Lindsey Dinneen: Awesome. Stephanie, what would you teach? [00:35:44] Stephanie Rupp: Yeah, maybe we, Ryan and I, could do a master class together then because he said, like, then we could explain the similarities or the differences between, US patent law and European patent law, and can also maybe, also add something about the UPC that we have now, the U- Unified Patent Court, and have a, maybe a lively discussion about all of that and, how to get the strongest and broadest, patent in the different jurisdictions. And as Ryan said, there are, like, some similarities, and I also have the feeling when I discuss with Ryan that, when we have a patent application where we struggle to get a patent on, then we usually also struggle with that in the US- Mm-hmm ... or the other way around. And, but of course, there are, like, differences in how the EPO and how the USPTO, like examine these AI inventions and, in the US you have these 101 objections that you usually get. In, Europe it's, they apply the so-called two hurdle approach where they, especially the second hurdle is usually harder to overcome. Mm. And that's also what, Ryan mentioned, is that you have to show the EPO that your AI invention or your AI steps contribute to the technical character of the invention. And that's, often, and I totally understand that, hard to grasp for an inventor because they think we have all these technical means here. We have a server, we have a processor, we have a memory, we have sensors getting data. Do you tell me now that that's not technical? [00:37:18] Lindsey Dinneen: Mm. [00:37:19] Stephanie Rupp: And, but that's not how the EPO thinks. It's, for them, they say, "What is your motivation for that invention?" Or, or in other, more their words, "What kind of technical problem you try to solve?" [00:37:32] Lindsey Dinneen: Mm. [00:37:34] Stephanie Rupp: And that is, what we also usually ask the inventors in our f- like, first meetings with them, "What is the technical problem you're trying to solve with that, and how does the, your AI steps, your method steps contribute to that?" Because that's, if you cannot show that to the EPO, then it's very hard to get a patent on. so maybe my combined master class- yeah ... where we show that and- It, [00:37:59] Ryan Phelan: It would- ... [00:38:00] Stephanie Rupp: Explain that, yeah. So ... [00:38:01] Ryan Phelan: Definitely it would, it would help out my meager EPO slide, any additional information on this, especially the, the UPC, which I'm glad you mentioned. But, maybe, we could take a minute to talk about the UPC and in, in the European area since that's like a new, newer, from what I understand, a newer avenue, the era approach in Europe. [00:38:20] Stephanie Rupp: Yeah. Yeah. It's, so as I said, we have, like, for now three years now, the, Unified Patent Court. And, before that we also had European patents, but once it was granted, was divided into national patents. So if you wanted to, file an infringement action or a nullity action, you had to do that in each specific country. And that made it very complicated because I, I'm a German patent attorney. I don't know anything about Italian law, so you would then need an Italian patent attorney or French and so on. So it was, like, very complicated. And, so what we now have, and that is, like, very exciting to live at that time now, is, the Unified Patent Court, where it's, like, now centralized and you can attack patents at the, like, Unified Patent Court, like, for the whole patent, and you don't have to go to these before the national courts anymore. And, so that's, like, very exciting for us as well because case law is evolving now and, there's, yeah, you can see how, like, how it changes and how the judges are handling these cases and it's, like, also very, like, for us, a lot of new things to learn. [00:39:32] Lindsey Dinneen: Yeah. [00:39:32] Stephanie Rupp: Yeah. [00:39:33] Ryan Phelan: Yeah, I was gonna say, I, I also heard, and, Stephanie can certainly chime on this, that certain cities in Europe, like Paris, or Munich, may have different judges that specialize in different arts or disciplines. I think, was it, w- what Munich was, I can't remember, is that the mechanical or- Yeah. [00:39:49] Stephanie Rupp: Yeah. So that's, like, for the central division, but we also have then local divisions- Mm-hmm ... as well. So we have, four local divisions in Germany, but also in other countries. And that also, changes, of course, a little bit of how they handle the cases because the judges, they often came from the, like, the national courts. So they, like, when you're in Germany, of course, they still have little bit, little bit more of the German thinking in them. When you're going to a Dutch, local division, then they have a little bit of, like, another, like, view on that. And I think over time it will, like, unify a little bit. but these are, like, also differences that, makes it very interesting, to see. [00:40:27] Lindsey Dinneen: All right. Okay, so next question is, how do you wish to be remembered after you leave this world? [00:40:35] Ryan Phelan: I hope that people remember me as, somebody that was fun, like to, you know, either work or hang out with that regardless of whether we're working hard or, you know, playing hard, that, that it was just fun. So that, that's my only wish. So or, or main wish. [00:40:50] Lindsey Dinneen: Love it. Steph? [00:40:52] Stephanie Rupp: Yeah, I think for me that I was maybe, like, a fair and trustworthy person. I think it sounds a little bit boring, but, more when people work with me and they, like, say, "Oh, when she gave me advice, I knew that she had, like, my best interest in mind as well, and not only, like, filling her own pockets or, like, trying to, like, improve it for herself, but having like..." Yeah, when they remember me of a person that you could trust with the advice, I think that would be, like nice to know for me. Yeah. [00:41:26] Lindsey Dinneen: Yeah, for sure. All right. Excellent. And then final question. What is one thing that makes you smile every time you see or think about it? [00:41:37] Ryan Phelan: I guess just sticking with our current theme, if in a work capacity, when a client gets a victory of some type certainly makes me smile. A lot of clients are happy when they get their patents allowed, or if you win that litigation case or you, you do things, a lot of times in the US we'll, we'll have these decisions or these patents, and it it, it, it makes me smile to think that, you know, I helped their business in that way to protect their, their IP and just going forward. I, I imagine it's a pretty standard answer, but, you know, certainly in the context of this podcast, that's absolutely one thing that makes me happy. [00:42:10] Stephanie Rupp: Mm. Yeah. I'm a person, I get excited very quickly or, like, really small things make me smile already. So I arrived on Saturday in Chicago, and I, for example, didn't expect to have a gym in the hotel, and then suddenly I discovered that and was really happy about that. So these are these small things that other people say, "Oh, yeah, whatever." but I think what makes me smile the most is, like, knowing that I have a weekend ahead of me with, like, my family and my partner, and we go ski. And I say that now we have, like, summer outs and, like, very warm temperature here in Chicago. I think it's about 80 degrees, and I'm already thinking about skiing and snow, but it's, more of... [00:42:52] Ryan Phelan: It's never too early. [00:42:53] Stephanie Rupp: Yeah. But more of, like, not the skiing per se, but just having time with family and- yeah ... clearing my mind and stuff like that. So, yeah. [00:43:02] Lindsey Dinneen: Excellent. Excellent. Well, thank you both so much for being here. I've so enjoyed the conversation, and you gave so much amazing advice and guidance, so thank you so very, very much for all of that. If folks who should be looking out for services such as yourselves, how do they get in touch with you? [00:43:25] Stephanie Rupp: I think like through the website, that, I think will be- mm-hmm published, with the, podcast. And, also my email address as well. You can find me on the website, or we can also add it to the, to the podcast info. yeah. [00:43:38] Ryan Phelan: What is your... [00:43:38] Stephanie Rupp: It's the easiest ... [00:43:38] Ryan Phelan: What is your email address, Stephanie? [00:43:41] Stephanie Rupp: It... Hopefully I say it correct now. It's, S for Stephanie, S Rupp, my, last name, @hoffmanneitle.com, so very easy. Yeah. [00:43:53] Ryan Phelan: Perfect. Excellent. Yeah, same thing for me. I believe the contact information will be at the with the podcast, but I can be reached at RPhelan R-P-H-E-L-A-N @marshallip.com, and welcome any questions or comments. [00:44:08] Lindsey Dinneen: Awesome. Well, thank you both so much again for your time today. We really appreciate it. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. Love learning about you, about your areas of expertise, and just really appreciate you, being willing to share with us. So thanks again, and, I suppose until next time. [00:44:51] Ryan Phelan: Thank you. Love to come back. [00:44:53] Stephanie Rupp: Thank you. Awesome. Yeah. Thank you so much. [00:44:55] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Dr. Andrew Holman is a rheumatologist and the CEO of Seattle-based Inmedix, which recently received FDA clearance for the first cloud-based heart rate variability (HRV) diagnostic platform. Dr. Holman shares how a “detective” mindset led him from early interests in orthopedics and cardiology into rheumatology, fibromyalgia research, and ultimately entrepreneurship. He explains how chronic stress, the autonomic nervous system, and conditions like sleep apnea and restless leg syndrome can influence cardiovascular risk and autoimmune disease outcomes, and why measuring stress biology with medical-grade precision matters. Dr. Holman also offers hard-earned advice for physician-innovators, reflects on pivotal study results, and shares what he hopes to be remembered for: never dismissing patients in distress.  Guest links: https://www.inmedix.com | https://www.linkedin.com/company/inmedix-inc Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 088 - Andrew Holman [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to be welcoming as my guest Dr. Andrew Holman. Dr. Holman is a rheumatologist and the CEO of Inmedix, a Seattle-based medical diagnostics company that recently received FDA clearance for the first cloud-based heart rate variability diagnostic platform. He has 25 years of clinical experience with 16 peer-reviewed papers and clinical trials demonstrating that measuring stress biology with medical grade precision can improve success rates in autoimmune diseases. All right. Andrew, welcome to the show. I'm so glad you're here today. [00:01:30] Andrew Holman: Yes, happy to be here. Thank you for inviting me. [00:01:33] Lindsey Dinneen: Course, of course. Well, I would love, if you wouldn't mind starting out telling us a little bit about who you are, what your background is, and what led you to medtech. [00:01:44] Andrew Holman: Sure. Well, I'm a, a guy from Seattle, Washington. Grew up here, but trained everywhere else, became a rheumatologist. We study autoimmune diseases, lupus, rheumatoid arthritis. I also was very interested in fibromyalgia and pain. We're the immunologists of medicine. So, I started my practice, golly, a while ago. 1992, I finished my prac- my training, and I was the main rheumatologist at a large suburban hospital at the southern end of Seattle. So hometown, circle back to the hometown. I went into rheumatology because you have many choices when you do internal medicine. You can go be a specialist in many things. But I like the puzzles. The immunology has grown and it's a, it's a particularly sort of detective-oriented specialty. So, I didn't set out to be an entrepreneur. That came 25 years later. I was an in-the-trenches doc trying to help the person in front of me with these devastating diseases that are crippling diseases, usually of young women mostly. [00:02:45] Lindsey Dinneen: Yeah. Okay, and I'm sure there's, there's much more we're gonna dive into, but one thing that really stood out really fast was you, you kind of called yourself a detective, which I really love that term. And so I'm curious, is that something that you always thought you wanted to specialize in, in medicine, or was this, you know, detectiving to come later? Was this something that, you know, you ended up learning more about while in med school and thought, "Oh, this sounds really cool. I could put really two interesting passions together"? [00:03:19] Andrew Holman: Yeah, it was-- you know, things just sort of come into play sometime. For those who are not in medicine, they may not realize it takes about ten years to go to college, med school, re- internship, residency, fellowship, you know, and then you, then you finally get to go be a doctor, and you have to go learn how to be a doctor s- a little more. The patients teach you a lot more than people realize. So I was gonna be an orthopedist. I liked orthopedics. I liked architecture, bones, joints. I thought it was a lot of fun. I just had very little aptitude for what they do. I, I don't-- I, I'm not very g- a good carpenter. I just, you know, I didn't-- just wasn't gonna be a great orthopedist. So then I thought, "I really love cardiology." Rhythm disturbances, all kinds of things. In the 1980s, when I was in medical school , all the new stents and procedures and non- less invasive things than bypass surgery were all coming up. Joint valve replacement. You know, it's really exciting. But I never... and I never took a, a f- a course in rheumatology until I was actually an intern in internal medicine program in Denver, all set to be a cardiologist. And there were 12 of us in the, in the program per year, and s- five of us became rheumatologists because of this one doctor who took us out, a guy named Daryl McCarter. Prob- maybe people who know him, he's retired recently. He would bring us in the office, and we'd see every other patient with him because in between the patients, he would give us an X-ray, say, "I want you to look at this. There's a clue here. See if you can find it." Or, "I want you to look at this pathology slide," or something. "There's a secret, you know, to figure this one out." And I go, "Wow, this is really fun stuff." And once you figured it out, we weren't as good at treating it yet, but we were getting better. We were getting better. So it was the cutting edge and very fertile ground for discovery. So, rheumatologists are called the consult of last resort for a reason. There aren't very many of us. You've usually seen everybody else first, and by the time they-- you see us, we're pretty good at figuring out the rare diseases that are not in other people's board exam. But we're also pretty good at figuring out the common disease that presents in a very strange way, you know? And, and that's what our strength is. So we may... Everybody who sees us who gets diagnosed may not have a rheumatology answer, but we try to get them an answer. And now we're really in the golden age of rheumatology in the last 20 years of really making a difference for so many people. The downside, we don't make a difference for enough people, you know? We, we... That's the problem. So we've got these very motivated doctors out there, eager, and we just need, you know, more. And that's why I became an entrepreneur, because I learned more neurology than I was supposed to know and more sleep physiology than I was supposed to know. You just follow the breadcrumbs, you know? [00:06:17] Lindsey Dinneen: Yeah. Okay, so I know you didn't start out wanting to, or maybe even being interested in being an entrepreneur, but that is the path that you chose, and I would love to hear about that, the company, and what you're all doing. And then also would love to hear about your journey into deciding that this is the next right step for me. [00:06:38] Andrew Holman: Yeah. Well, thanks for asking it. It is a little unusual. So I was actually studying and trying to help patients with fibromyalgia about 30 years ago. And fibromyalgia patients terribly dismissed till they're all making this up. There's not 10 million people that can make anything up and be consistent. I mean, they all say the same thing. So I thought that was nonsense, and I was really thrown into the crowd of, you know, "You're, you're crazy too." And I go, "Well, I'm board certified in crazy." So I w- I was interested in it, and I was irritated that these people were dismissed. And I was around other doctors in Seattle who were similarly that way, which was very, very unusual. It's unusual to find people in the '90s who had an avid interest in that disorder. And so I started doing what rheumatologists are good at, incrementally advancing ideas and therapeutics very carefully, very cautiously. We do a lot of things off-label. When I was-- finished my fellowship in 1992, half the diseases on our board exam had no FDA-approved treatment. We had to do something, right? You couldn't just say, "Well, come back when there's a couple of articles in the New England Journal of Medicine." You, you can't do that, right? People are depending on you. So rheumatologists are particularly good at that, and that's not something most doctors want to do. Most doctors find that very uncomfortable. They're very, very careful people. And, and rheumatologists are careful too, but we take this mission seriously that we need to do something for you. So basically, I was looking at off-label ideas and work on fibromyalgia, and I'll share this with your audience. I was actually pulled up-- pulled in by some senior doctors who said, "We wanna talk with you." And I'd been there about three years as a new doctor. Oh, you know, seem to be doing a good job. Maybe they wanna pat me on the back or something. No, not that. It was actually an intervention, which I had never... I mean, I had no familiarity with what an intervention was. And they said, "Look, we like you. You're a great doc, but you're gonna ruin your reputation if you believe all these people, mostly women And you really need to not take it so seriously or write prescriptions for this c-- this and that." I said, "Well, thank you very much." That's polite. That's not what I was thinking. And I, I... But it prompted me to pull all the charts and say, "You know, I think I'm making some progress here with some ideas here, and let me see if I'm getting fooled and just seeing the people who get better to come back. Let me really honestly look at my performance." And so I pulled about 200 charts. It was my first abstract at the national meeting. And you know what? We were making progress. That had morphed into more progress, following the breadcrumbs, looking at neurology, looking at the autonomic nervous system. So that was about a five-year process. Y-you know, I didn't lose my reputation, obviously. I lecture around the world now. But it led to being very careful about getting clinical evidence if I had a hypothesis. And so we were using the office, and we actually finally did a double-blind prospective study where I bought all the drug myself, had it reformulated, little capsules that, you know, and, and worked with the FDA to get permission to do the study. And that study in fibromyalgia to this day has the highest response rate of any fibromyalgia study for pain that's ever been done. Now, we don't use that treatment anymore. It's 20 years later, we have other things to do. But it did prompt Pharmacia, got bought by Pfizer, I believe, and Boehringer Ingelheim, which co-marketed the drug I was using and reporting on, to pay me $10 million for the patents that I had filed, utility patents. I didn't own the drug. I didn't use it for Parkinson's disease, but I thought there was use in fibromyalgia. So before I told the world, I filed utility patents, and they wanted to exploit that discovery. So did two other pharmaceutical companies, and they had to pay for the privilege of doing it. So at 46, I retired. So I didn't intend to do that, but I do come from a family of lawyers and judges, and so the idea of having a utility patent on a n- a new innovative idea was not a foreign concept to me. [00:10:40] Lindsey Dinneen: Yeah. [00:10:41] Andrew Holman: That is something I teach all young doctors. [00:10:46] Lindsey Dinneen: That is awesome, and I, I was thinking, okay, this is a great segue because first of all, that's an incredible story. Secondly, I, I would be very curious to know exactly that, what is your advice for some of these incredible physicians, great ideas, that are potentially going to end up becoming an entrepreneur just because that's the path that, that is sort of presented to them? What is some of your advice for that? 'Cause that can't just be... you, you had the privilege at least of, of, of knowing and having some background in that, the legal aspects of IP protection and whatnot, but what are some of the things that you tell people? [00:11:22] Andrew Holman: Well, a couple things I would say and I have these conversations often 'cause I really like the younger people coming along. I say, first of all, don't define yourself as an ent- as being an entrepreneur. Make sure you have other things in your life that are more important to you. Now, the investors are not gonna like to hear that. They, they want you to live and die on your, on your company, right? But I'm saying, you know, you don't have to tell the VCs, but have other things that matter more in your life. You still gotta work really hard because you may, you may find that it's really a slog, and it's very long, and it's very hard. But, you know, make sure that, that, that what you-- though is important, your family, you know, your integrity the scientific problem at hand, the patients, you know, they're number one. Make sure we don't lose sight of all that, and do a few things. Go for a walk. Do something for yourself. Something. I do this twenty-four seven for the last 10 years, you know, every day 'cause I love doing it. It does wear you out, though. Even if you make-- even if you're successful with milestones, it does wear you out. But that's what I tell them. I say, "You know, make sure that you take care of yourself a little bit, too." It's kinda like a analogy. What do you do for a pregnant woman who has a, who has a, a lupus? Lupus is terribly dangerous for the fetus and for the mom. Though the worst thing you do to-- for the baby is not take care of the mom. Take care of mom, [00:12:44] Lindsey Dinneen: Mm-hmm. [00:12:45] Andrew Holman: then get the baby delivered. So, you know, everybody's talking about the baby, but take care of mom. That's the most important thing you do for that baby. So that's kinda what I would say. [00:12:54] Lindsey Dinneen: Yeah. Yeah, that's great. I appreciate that. Yeah, that, that makes a lot of sense too. We've been talking, actually it's been a, a bit of a theme too lately in some of the conversations that I've been having with folks, especially leaders, to talk about that identity component and, and be aware that your job isn't the only thing that defines you or needs to. There's a lot more to your life. There's a lot more to who you are. And so also, you know, our identities change over time and how you refer to yourself and th- those are, those are good things. That's growth, that's movement. So, being comfortable with who you are outside of your career. Yeah. [00:13:33] Andrew Holman: The other thing too is, you know, people used to joke 20 years ago that participation mem- medals were like a farce and what. That's the l- that's the last thing I would say to anybody. Give yourself a pat on the back for going out there trying to attack the castle, you know. Give yourself some credit there because a lot of people just wouldn't do it. My middle daughter was a hundred-meter hurdler at Boise State. She's a Division I athlete. There's a lot of sprinters out there that don't wanna get anywhere near that hurdle 'cause it really hurts when you hit it, right? And so half of that was not-- was being brave. So be brave, be brave, you know. My other daughter was a Division I athlete at Rice. She was a h- she was a volleyball player. Yeah. So, yeah. So I, I, I, I watch other people, see how they persevere and, you know, okay, gotta pick yourself up. Gotta go. Gotta get up this morning. Gotta go. [00:14:23] Lindsey Dinneen: That's right. That-- Yeah. [00:14:25] Andrew Holman: Then remember, people are depending on you, not just your investors. I take that so seriously. But the s- the people who have decided that they're gonna hook their wagon to you. [00:14:34] Lindsey Dinneen: Yeah. [00:14:35] Andrew Holman: You know, that's a lot of responsibility. [00:14:37] Lindsey Dinneen: It is. Yeah. [00:14:38] Andrew Holman: Give yourself a little credit that you're stepping up. [00:14:41] Lindsey Dinneen: Yes. Great advice. Yeah. Okay, so all right. So let's talk about your company now. So now you're an entrepreneur, in addition to obviously the rest of who, what makes you, you. But and I know that you're also a clinical professor, and I would love to hear about both of those things if you don't mind sharing. [00:14:59] Andrew Holman: Yeah, sure. So, technically I'm an associate clinical professor at the University of Washington. A, a lot of private docs do, and they participate in helping teach the y-young residents and fellows and so forth. So it's a joy to me. I, I think my job is a job of teaching. I'm constantly talk... I'm not-- I don't see patients anymore, although I do maintain my license in malpractice 'cause I get, I get contacted for the fibromyalgia work I did. So it's, my email's on the papers, right? So I, I don't wanna let that go. People need help. But basically, we're constantly teaching patients, you know. Now, we're listening, hopefully do better and better at that, but then I have to make a case. You know, I'd, the-- I'd like you to try this or that. Why do I wanna do that and so forth. We're constantly, you know... We don't-- It, it sounds too trite to call it selling something. We're not doing that. We're in there with you. We're collaborating. But I have to be, I have to have a reason and be persuasive and all that, so that, that academic teaching part's kind of fun. Now, sometimes I go into the lion's den. I will tell you, it's a little nerve-wracking to give rheumatology grand rounds at Harvard. Yeah, yeah, okay. You know, and the University of Washington, they're a little friendlier. It's my hometown. But Guy's Hospital in London and the Hospital for Special Surgeries, I... My first rheumatology grand rounds came at the HSS in 2009. I get there, I completely bomb. All these famous people are in the front row. I'm... They're, they're just not buying any of this thing we call immunoautonomics and how stress affects the immune system. I'm quoting the NIH. I'm doing everything I... I know how to do it, right? Pathology slides, I'm there. Then I find out the way they pick the speakers is the fellows get to find something interesting, and they pick the speakers, not the not the high mucky-mucks. So the only reason I was there is because the fellows, the young folks, thought, "This is an interesting topic. We'd like to hear more." And it turns out they were 15 years ahead of the rest of the world, because this is the most fascinating topic of how the immune system affects the autonomic nervous system affects the immune system, so it inflames it. [00:17:03] Lindsey Dinneen: Yeah. Oh my gosh. Actually, that is one thing I wanted to talk about, 'cause I, I noticed on your LinkedIn profile there was, you know, a reference to how much stress affects cardiovascular health maybe particularly chronic stress. And I would just love to hear more about that and, and maybe some ways... I know there's like, y- of course you always get your standard, "Here are some things that you could do to lower your stress." But, but from your perspective as a physician who's studied this, I'd love to hear more from you about, okay, how does this affect health, especially cardiovascular health, and then really what are some practical things that we can do? [00:17:39] Andrew Holman: Yeah, let me see what I can do. Now I wish I could fast-forward because we will have some magnificent things in the next five to 10 years based on what's being discovered now. But the bottom line is, stress and pain are awful things, but they have a purpose in the near term. So pain is good because it'll keep you from putting your hand back in the fire, right? Just don't do that again. But chronic pain is terrible and not productive. Stress is the same thing. You wanna get away from the lion. You, you, you need to perform. If your child needs you, whatever, you, you need to perform on it instant. But chronic stress is not productive. The problem with the stress response is it's controlled in the brain by the autonomic nervous system, which is called the ANS, and it's divided into two components, the sympathetic fight or flight, which we all know what that feels like. You know, ooh, scary. And the other is the parasympathetic, which is getting more talk now, which is the opposite, which is related to rest, restorative, sleep, recovery, growth hormone, all these things. And both of these systems are on simultaneously all the time, but they jockey for predominance depending on what the demands are around you, right? So turns out the sympathetic part has a significant negative impact on cardiovascular health, as you might expect, right? If you're driving your car at five thousand RPMs-- now, nobody has a stick shift anymore-- but if you're driving at five thousand RPMs, you're gonna wear down your engine, even if you go at the same speed as someone who has a two thousand RPMs, right? It, it's, it's what's going on inside the hood there is really important. So stress responses chronically do have measurable, tangible, well-published effects on cardiovascular mortality in long prospective studies. So if we had a magic something, we would do something to lower that epinephrine adrenaline response. Unless, of course, you're in the military, where someone's-- you need every heightened, m-- you know, response that you can get to survive. But for the rest of us, it's better that that system does not ramp up and activate. And we all have a different propensity to how powerful it is and how much it turns on, and also how poorly it turns off. So the stress response, we think of it like epinephrine, adrenaline. That's the easiest way to do it. So what you'd wanna do is to make sure this magnificent part of your brain that is your-- does all your housekeeping functions, this autonomic nervous system, the command and control center that you just wanna work, you don't wanna think about it, is not on a turbocharged, right? And there are people I take care of that they were just born that way. A lot of them, by the way. So things like all the wellness opportunities you can think of are, are targeted just to simply calm the autonomic nervous system. Tai chi, meditation, diet, exercise, all these things have been around for thousands of years because of that. That's what they do. And the practitioners will share that with you. I mean, the there are monks that can lower their heart rate, you know, to like, you know, what would seem lethal to the rest of us, right? That's the parasympathetic drive that lowers heart rate, lowers blood pressure. So those wellness opportunities are real. It will be important that you can manage whether the-- what you're doing is working or not. [00:21:04] Lindsey Dinneen: Mm-hmm. [00:21:04] Andrew Holman: Right? And that's where my company comes in. But the other is things like obstructive sleep apnea. You might think heavy guys... See, someone's gonna send me for a sleep study for sure, but they're not gonna send you. Big mistake, because it turns out that fifty-three percent of Japanese women with rheumatoid arthritis have unexpected obstructive sleep apnea. Oops. And, and we were just taught that we wouldn't even check those people. Well, turns out sleep apnea untreated is a major cardiovascular risk factor equal to cigarette smoking, according to the Sleep Heart Health Study in 2004. That's a big deal. And also, we learned in rheumatoid arthritis, getting back to my work, world, that patients with rheumatoid arthritis don't die from joint disease, they die from premature heart disease. They can also get cancers. So why is that? Well, there's been a lot of effort to try to figure that out in the last twenty-five years, and their risk factors for cardiovascular disease are not explained by the Framingham risk factor of hypertension, cholesterol, smoking, and all the things we, we look, see. But nobody looked at sleep apnea. [00:22:15] Lindsey Dinneen: Mm-hmm. [00:22:17] Andrew Holman: The other reason it's so relevant, though, is sleep apnea is a potent sympathetic arousal. It, it-- You struggle to breathe, right? You kind of obstruct. And what part of your brain tells you to breathe? Your autonomic nervous system. Breathe, right? And it stimulates this adrenaline response over and over and over, and it pounds your heart over the years, and it can lead to sudden death and arrhythmias. So there's a, there's a link there. Never miss sleep apnea. The other one is we found in our office and published about restless leg syndrome. You know, people tap their toes in the airport or they kick the covers around at night. It's pretty benign for most people, but it looks like it very well might be a sympathetic arousal, and there may be relevance there. The therapies for that may have relevance to what we're talking about. Again, very off-label. We're not talking about FDA-approved here. But it-- You ask what can you do? The other one that's coming is vagus nerve stimulation. That is FDA-approved now for rheumatoid arthritis, and they're going to other opportunities to, again, to, to increase the parasympathetic and to lower the sympathetic, right? So that background activity doesn't harm you. The autonomic nervous system may be the primary reason that two patients respond differently to the same treatment. What you bring to the table. It's no different than if I have two people coming to me for a back problem. One is five foot three and one is seven foot three. The way their spine is designed makes it a whole lot harder to treat the seven-foot back, right? I'm not surprising anybody here. So there are things that the patients can bring to the table that matter. Here's the irony. Ninety-seven percent of patients with rheumatoid arthritis in a survey in England said that stress affected their disease activity. It's no surprise to them. And sixty-five percent said they thought it predated getting the disease, that it actually contributed to getting it in the first place. And now there's evidence to suggest that may be true. [00:24:17] Lindsey Dinneen: Oh, boy. [00:24:19] Andrew Holman: So we can't miss sleep apnea just out there. We can't miss restless leg. We can't miss Ehlers-Danlos type three hypermobility type where people can... you can't see me here, but my fingers can bend backwards. But it's, it basically it's very, very common, and those people tend to have increased sympathetic activity naturally. [00:24:39] Lindsey Dinneen: Fascinating. [00:24:39] Andrew Holman: So yeah, so we're, we're waking up a little bit to some very important features here of individuals that may help us do better with the diseases they also come in. [00:24:50] Lindsey Dinneen: Yeah. Wow. [00:24:52] Andrew Holman: Sorry, long answer. Sorry, but there's a lot. [00:24:54] Lindsey Dinneen: No, that's great. I appreciate it, and yeah, well, then there you go. Managing stress is critical to, to your health. It's not just a nice to have, like yeah, yeah, kind of thing. Okay. Whew. [00:25:07] Andrew Holman: Good learning. [00:25:08] Lindsey Dinneen: Okay, awesome. Yeah, so, I'm curious... Okay, so, so again, I like, I like looking at guests' LinkedIn profiles and, and learning more about, you know, what makes you tick outside of your career as well, and I noticed some very fun things that you have listed. So we've got creative writing, horsemanship, golf, and vintage passenger rail cars. I feel like this warrants... [00:25:33] Andrew Holman: Yeah, it's called... Yeah, the American Association of Private Railcar Owners. Yeah. I get ribbed a lot for that, but they're a great bunch. There are about --I don't know if I know all the numbers now, but about 75 to 80 vintage cars from the '20s, '30s, '40s, '50s, who tag on the back of Amtrak, and Amtrak drags them around, and you can actually go rent them, stay in them, whatever. And they have a a annual meeting where they just get on a private train, and they go on tracks that you wouldn't go on naturally, like private rails in the, you know, middle of nowhere. So that's what they like to do. And it's just a lot of fun, especially the dome cars. [00:26:12] Lindsey Dinneen: Okay. That's so cool. [00:26:14] Andrew Holman: I've been a handful of times. I've got a lot of friends there. I don't own a car, but boy, I'd sure like to have one. [00:26:19] Lindsey Dinneen: Yeah. Okay. That is so cool. And then how about horsemanship? How did you... Have you been riding horses your whole life, or how did that come about? [00:26:29] Andrew Holman: So I went to a high school called Thatcher School in Ojai, California, where there are 50 in a class, and there was a requirement, this is over 100 years old, this school, that you had to have a horse. And they would say s- that something about the "outside of a horse is good for the inside of a boy," right? I was the last all-male class in 1977. Now young women get to go there too. It's of note that I have 15 people from Thatcher investing as family and friends in, Inmedix. So, th-they that, that's pretty special. But it's a boarding school. I was there for four years. My dad had gone there, so I'd heard of it. But I got a tremendous education. Th-there aren't a lot of prep schools on the West Coast, but there are some. And, and that's where I learned how to ride a horse like riding a bicycle. My sister is a thoroughbred horse trainer for 40 years. She's retired. She had three or four or five horses, a har-- not the fancy kind of stuff at the Derby. But they, you know, get up at 4:00 a.m. and ride, you know, that kind of... Tough life, but she loved horses. So yeah, I, I'm as, I'm more comfortable on a horse than I am around anything, probably. [00:27:34] Lindsey Dinneen: That's so cool. Okay. Well, this has been really fun to, to get to hear your incredible life story so far, and I'm excited to see where the company continues to advance medical technology. So, you know, I really appreciate everything you're doing. But I do want to ask, is there a moment that stands out to you along your career path so far where you just thought, "Wow, I am in the right industry at the right time"? [00:28:02] Andrew Holman: Yeah, I'd, I'd say there probably was. When we unblinded the prospective double-blind study that we did looking at this five-minute next generation heart rate variability, this HRV we got through the FDA last year. When we unblinded the study, and although that's not part of the FDA clearance, it was a very important moment for me because it showed that it predicted a year in advance who would respond to treatment of rheumatoid arthritis with ninety percent sensitivity, ninety-five percent specificity. So I wanna emphasize that is not what it's cleared for. It's cleared as an HRV tool that doctors can use at their discretion. But that study is what you asked me to answer. And when you unlock a study and you see the results, two things happen. One is we were happy that I was on the right track. That was nice. You know, positive study. Your hypothesis is valid. But it completely changed the view of immunology, [00:28:58] Lindsey Dinneen: Hmm. [00:28:59] Andrew Holman: Because we would have a test now that could measure the autonomic nervous system with exquisite precision. Nobody cared except me. About 10 years ago, we were waiting for better biologics, the things on TV, right? They asked, "Ask your doctor if it's good for you." Nobody realizes that they work about twenty-five percent of the time in terms of disease control. That's a big gap, but it looks like it's the brain that monitors inflammation. The inflammation the immune system is not firewalled against everything. The brain c-controls it, and it's not the endocrine so much with cortisol, it's the autonomic that works in milliseconds that, that epinephrine response. So that's a... You know, you're pretty nervous when you un-- when you-- someone tells you, "Okay, here is the results." [00:29:48] Lindsey Dinneen: Yeah. Wow. [00:29:50] Andrew Holman: And, and, and that was it. And then it turned out in 2015, the other moment was when I was going through the airport at Seattle and I saw the cover of of Scientific American, Bioelectric Medicine, Setpoint Medical's vagus nerve stimulation, hacking the the vagus nerve to fix the autonomic nervous system to reduce the burden of rheumatoid arthritis. I go, "Okay, now it's time." We had the patent on it. Okay. Ten years forward, we're where we are now. We're launching in June, and we have a software juggernaut here and a literally a vital sign. So, th-the doctors decide what to do with this, but we've put it in their hands, and it's paid for by insurance. So yeah. [00:30:34] Lindsey Dinneen: Amazing. Well, that's, that's so cool. Congratulations on that. That's fantastic. Okay, so to pivot the conversation a little bit just for fun, [00:30:43] Andrew Holman: Hmm? [00:30:43] Lindsey Dinneen: imagine that you were to be offered a million dollars to teach a master class on anything you want. What would you choose to teach? [00:30:53] Andrew Holman: Well, I, I learned that you've all had professors that didn't probably know as much as they should about a subject, but they thought it was just fun. I would probably stick with what I know. So I would do a master class on fibromyalgia because you can actually treat it. And there's published data, but it's very-- it's not widely known. We will be using Inmedix and autonomic testing to do research to validate and get that problem finally solved and put to bed. And then the other is this thing called immunoautonomics. It, the term-- I made up the term 15 years ago. It's in the medical literature. So that's what I would teach. Teach what I know. [00:31:27] Lindsey Dinneen: I love that. Okay, excellent. And how do you wish to be remembered after you leave this world? [00:31:34] Andrew Holman: Well, I, you know, it all come... I define myself by what the patients, how they do and what they say. It's not about five stars and all that, you know, you know, there's plenty of those. But it's, it's... I made a, a commitment if somebody says anything about me, I made a commitment when I was a rheumatologist with all these mostly young women upset, that I would never leave the room with them crying. Didn't matter how far behind I was, didn't matter. We went through a lot of Kleenex. There's a l- it's devastating to get these diseases when you're a young woman. And they can put that on my tombstone, not to dismiss people. We had a saying in the office, "It's gotta be something." You know? It's, it's always something. Drives me crazy when doctors will say, "Oh, that's nothing." Well, well, first of all, we know it's not nothing. It, it is always something, and there's something that defines your success, and there has to be things that define your failure. So let's figure out what the something is, but let's not argue that there's nothing there. So let's not dismiss people who are frightened and worried, and maybe they don't tell the story as clearly as we'd hope. But you know what? It's not, it's not their fault. They're in distress. It's amazing what people are like after you help them with their chronic pain. [00:32:45] Lindsey Dinneen: Yeah. Yeah. That is really cool and makes so much sense. Yeah. Thank you. Okay, and then final question: what is one thing that makes you smile every time you see or think about it? [00:32:59] Andrew Holman: It's making me smile right now. When I talk to the young fellows that are in their training and they're finishing up, so they've done three years or four years of medicine, three years of internal medicine after that, and then they do three or two, three, four years of rheumatology, and then they're gonna go out, I tell them how jealous I am of what they're gonna see. The, the last, the last 40 years we had these young men mostly coming in with terrible weight loss and immune systems, falling apart, and these strange tumors, and they're dying of, of infections like yeast and candida that, you know, everybody did fine with, and it was HIV, right? It had to be figured out. Now HIV is a chronic disease. It's like diabetes. We had so many people die in the '80s. Hepatitis C was... You'd have liver enzymes up, and it wasn't hepatitis A 'cause we could test for that, and it wasn't hepatitis B 'cause we could test for that. So we just called it non-A, non-B. Literally, that's what we called it. And then that got to be called hepatitis C, right? 'Cause it was too embarrassing to call it n- what it wasn't. And now hepatitis C is curable with antiviral agents in, like, three weeks. I mean... And then the biologics showed up. They're not perfect, but they were a big step. And then this immunoautonomics and, and understanding how pain and sleep and the autonomic nervous system work. I'm just really jealous of what those young clinicians are gonna get to see. [00:34:27] Lindsey Dinneen: Yeah. Yeah, that's really... Yeah, I can see why. But it sounds like you are, you know, keeping, keeping your what, what would they say? Like, toe in the water or something so that you're able to, to watch some of this as well and be a part of that next [00:34:40] Andrew Holman: I feel like I'm a ne- I feel like I'm neck deep and I'm just hoping I don't go down any lower. [00:34:47] Lindsey Dinneen: Fair enough. [00:34:48] Andrew Holman: 'Cause I have to find a way to pay for it. [00:34:50] Lindsey Dinneen: Oh, yeah, yeah, yeah. The details, you know. Yeah, yeah. [00:34:53] Andrew Holman: You got those details, yeah. [00:34:54] Lindsey Dinneen: Yeah. Oh my gosh. Well, this has been an incredible conversation. I really appreciate your time today and sharing your insights and, and stories and, yeah, I'm so excited to see the future of medicine, and I appreciate perspectives of, like yours, where you just, you share a lot of hope and optimism, and you're actively working to change lives for a better world. So, thank you. [00:35:16] Andrew Holman: Yeah, I, I irritate a lot of people with that optimism, but I'm sorry, it's just there. I can't fix it. [00:35:22] Lindsey Dinneen: Brilliant. Well, I love it. It makes my heart happy, so thank you so much again, and I hope you have the best rest of your day. [00:35:31] Andrew Holman: Thank you so much. Thanks for having me. [00:35:32] Lindsey Dinneen: Of course. [00:35:34] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Ofer Shalev, co-founder and CEO of New Phase, shares his journey from leadership roles across high-tech, biotech, banking, and even serving as a fighter pilot, to pioneering a nanotechnology-based hyperthermia treatment aimed at transforming stage four cancer care. Ofer explains how the company’s mission focuses on prolonging life while preserving quality of life through a systemic approach designed for metastatic disease. He discusses New Phase’s progress, including treating 33 stage four patients (including at Mayo Clinic), achieving stable disease in over 60% of cases after one month follow-up, securing FDA medical device designation and IDE approval, and building a science-driven team supported by patents and peer-reviewed publications. Guest links: https://newphase.co.il/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 087 - Ofer Shalev [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Ofer Shalev. Ofer is the co-founder and CEO of New Phase. With more than twenty-five years of management experience in the high-tech and biotech industries, Ofer leads New Phase operations and is pioneering a breakthrough nanotechnology-based treatment to transform the management of stage four cancer. Ofer combines deep technological insight with strategic business acumen. He previously served as CEO of several technology companies, including ReDent Nova, which led innovation in dental medical devices alongside his co-founder, Dr. Rafael Hof. Earlier in his career, he held senior leadership roles in the banking sector, including serving as VP of Operations, which strengthened his foundation in large-scale operational excellence. He holds an MBA from the University of Edinburgh and is recognized for guiding multidisciplinary teams, driving complex R&D initiatives, and scaling companies from concept to global market presence. At the core of his work is a clear mission: to redefine the future of cancer care by offering patients a safer, more targeted, and more effective treatment, one that not only attacks tumors but also preserves the quality of life. All right. Well, welcome to the show. I am so thankful you're here today. [00:02:09] Ofer Shalev: Thank you, Lindsey. Good evening. Very nice to meet you. [00:02:11] Lindsey Dinneen: Very nice to meet you too. So I would love, if you wouldn't mind starting off by just sharing a little bit about yourself, your background, and what led you to medtech? [00:02:25] Ofer Shalev: Well, I would say that during the year, I had extensive managerial experience across many multiple sector, including industry, high-tech, banking, and obvious-obviously life science. I have also to mention that about fifty years ago, in my experience I was a fighter pilot, pilot in the Israeli Air Force. It was, again, about fifty years ago. I would say that it probably significantly shape who am I today. I mean, it's developed my ability to to take a calculated risk, for example, or to act quickly and precisely to plan ahead, to build contingency plans. So all that kind of thing that probably was very relevant to the time I, I w- I used to serve in the Israeli Air Force, but also very relevant to the, to the industry. Okay? And furthermore, I would like to say that probably I am highly motivated by challenge. It, it's make my day. In addition, I am a father to four children and a grandfather of seven grandchildren. And I do hope that at the end, I will have about twelve grandchildren. So, the kids have still to work about it. Yeah. And I would say that you asked about myself, so probably I have a very, very strong belief in the path, in the way that I'm choosing. It's I would say, enabl-enabling to, to overcome about the difficulties, mainly when you're looking for challenge, especially in, in a new and unfamiliar field, like in our case of New Phase And furthermore, I, I, I, I truly believe in the word "never give up." You will find solution to everything. Never give up. I like very much as I mentioned before, to, to meet a challenge and to overcome our challenge many times by breaking some problem into pieces and then to assemble it again. Furthermore, I would say we, we met many, many problems in our life. I, I think that we have to focus about the solution, not about the problems. You cannot change problems. It's happened. But let's try to find and, and to think about how to find the right solution to it. And I would say that I, I f- I feel very, very, very good to to operate or to, to function in a turbulent area. I mean, I like it very much. I, I know that not, not, not anyone like it, but I feel very good in, in this area. [00:04:59] Lindsey Dinneen: Wonderful. Well, thank you for sharing a bit about your background. I have so many questions, but I would love to actually learn about what you're doing right now with New Phase, because I know you're passionate about it. There's, there's a lot that goes into cancer research and treatment, and I know that that's been such a challenge for so many years, and I love the fact that your company is really diving into that challenge and tackling it. And I was just wondering if you could explain where the concept of New Phase came from, and what exactly makes your company so unique in this space? [00:05:39] Ofer Shalev: So the, the idea came that it was 14, 14, 15 years ago, while me and my partner, Dr. Rafael Hof, we were involved with some other company, and after that at that time his mother, her name was Sarah, she wa- she had lung cancer. She passed away. And during that time, we have a very, I mean, many time conversation about the disease. No, no, no, none one, none one of us is, was oncologist, okay, by training. But we have many, many discussion about the treatment what are the relevant treatment that are available, et cetera, et cetera. And after she passed away we, I mean, Rafi, who is a great technology guy, came with this idea of nanoparticles and hyperthermia, and we start to work about it. Again, we have to learn, both of us, we have to learn a new area of technology, of biology, of chemistry, of physics, engineering, regulation, everything. And it was not only that we have read and learn about it, but we decide al-also to, let's say, to, to jump into the pool, into the water. We put each one of them, each one of us put some money. We hire some chemist. We also hire from one of the university in Israel some space. Like you, I mean, usually, I, I believe it's the right way to develop a company. I mean, to start and building it, the company, in the garage, okay? Right. And, and, and sure, you have, you have to-- you cannot just think about it, you have to, to, to do something. And the outcome was actually the proof of concept. We show in the in vitro, under microscope, how some very, very primitive nanoparticles were being irradiate, caused damage to the cancer cells. And that was the time that we founded New Phase. I truly believe that it's the right approach that first you have by yourself to, to deliver, to show the proof of concept, then go to investor and try to convince them to, to invest in your in your company. So that was what we have done. It was a very, very long way. I mean, the company was founded just 13 years ago. The vision didn't change. I mean, from the beginning, the idea was to prolong life of cancer patient, and in order-- and in addition to maintain the quality of life. At that time we used the word of chronic treatment or managing the disease, and many of the people that we met, skeptical one said, "But you, you don't cure the disease." So we explained that as we see in the next twenty years, nobody will cure the disease, but for the meantime, people have to live. [00:08:35] Lindsey Dinneen: Hmm. [00:08:36] Ofer Shalev: Now, the vision is still today. It was implemented into a technology. But yes, the technology was changed several time along the year, but the vision is still here, and that is, that is the, the outcome as of today. We already treated thirty-three patient with stage four, six of them in a Mayo Clinic, very distinguished hospital. I mean, I would say ranked number one worldwide. A great cooperation with them. I would say that till the summertime, we will treat another six patient, and after we move to the feasibility study, where we will have to choose few indication, and we will add another to a US hospital to join to the feasibility study. It become a product. As I mentioned, we treated already thirty-three patient. We have about fourteen patents that already granted. We have about, since we are-- we truly believe that we are in a deep science company, so we truly believe in the, in the scientifics based evidence, and we already publish nine peer review scientific articles. We have done a lot of work and success with FDA. First, and again, it was a breakthrough idea to, to succeed and get designation of medical device. Although we inject infused nanoparticle into the body, but we convinced the FDA that although we infuse nanoparticle, hence our mode of action, primary mode of action is actually engineering one or physical one, and therefore we were, we were designated as a medical device, which again save a lot of budget and, and time while reaching to the clinical study. And then later on, we got the IDE, I mean, the, the approval to start clinical study in the US. So we have done a very, very long way, and I would say that it's very satisfying while seeing today that first of all, we have a product, not only idea, and the vision is still here. I mean, what we can see that we... many of the patient, although it in the early feasibility study, and the main goal is to achieve safety and to show it's non-toxic. So even though we succeeded in more than about sixty percent of the cases we treated in nine different indication of cancer to reach to a stable disease. Let's say after one month of follow-up, the tumor metastasis are the same size, and there were no new lesion during that time. So, yeah, we-- I would say that it start, it start-- it seems that we start to reach to the, to the real game in the feasibility study where we will focus about two to three indication, and the idea is to treat patient for at least, let's say, six months, and to show that we can, we can keep them in a status of stable disease. [00:11:44] Lindsey Dinneen: Yeah. [00:11:45] Ofer Shalev: Further, furthermore, all the patients that we got, all of them are metastatic stage, let's say stage four, which exhausted all other treatment. So many time, you can see that in the retrospective data, before the joining to the study, the tumors or metastases have a progression rate of so and so percent per month, and after our treatment is dramatically reduced or even stopped. So, a lot of enthusiasm with the current status. [00:12:18] Lindsey Dinneen: Yeah, a lot of enthusiasm and a lot of hope. I, I love what you're doing because, yeah, as you said, I mean, at that point, people probably feel so stuck and hopeless. And so to be able to learn that there is technology that is being actively worked on that can... [00:12:36] Ofer Shalev: Yeah. [00:12:36] Lindsey Dinneen: ...really help them [00:12:38] Ofer Shalev: Yeah, yeah. We are-- you also ask what, what we-- what, what is the difference that we bring to the market? [00:12:42] Lindsey Dinneen: Mm-hmm. [00:12:44] Ofer Shalev: So the hyperthermia is well-known for many, many years to be a useful way to treat cancer. Okay? Because cancer don't have resistance to hyperthermia. And let's skip about all the biology factor, but this is a well, well-written evidence in, in the literature. So, but usually all the current hyperthermia methodology is a local treatment, meaning you have to define where the tumor is, CT, MRI, whatever, and to try, try to heat this tumor either by infrared or with-- or inject directly nanoparticles into the tumor, et cetera, et cetera. What we are offering is a totally a new approach of treating systemically in tumors at stage four. Let's say in many cases, you don't know even where the tumors are in the volume of treatment, meaning we treat the torso area. It's not that we are trying to find tumor by tumor. No. We're treating the whole area of the torso, and by that we can destroy the tumor, which in stage four are localized in, in different area in it. So this is one thing. The other thing that I would say that the stage four mainly people that exhausted other treatment is really can be considered as a unmet need. And that's, that's the population that we are focused about. That, that's the population that we are focused about. [00:14:11] Lindsey Dinneen: Yeah. Yeah, that is really incredible to hear. I, I love what you're doing. I'm curious, as you've gone about this process and f- you know, 13 years worth of learnings and growing as a company, what is something that's really surprised you along the way? [00:14:34] Ofer Shalev: Surprise? Well, you know, I said before, when, when you, when you start this this journey with a deep s-- belief in yourself and in your team, you're not really surprised. [00:14:49] Lindsey Dinneen: Hmm. [00:14:50] Ofer Shalev: Yeah, I mean, no, there is a lot of surprise. I mean, we, we went in an area which nobody stepped before in the, in those days. Nobody stepped before. But I would say it was obvious to me at least that okay, we are thinking about the right approach. We are trying to find our way. We invest a lot about trying to read whatever is relevant. We are speaking with oncologists, learn from them in many time about the failure, and try to make sure not to do it. So I'm not surprised. I'm very happy. And again, it's not... It was not by accident. On one hand, a very strong belief, and on the other hand, in-depth learning every piece of knowledge that we were able to collect [00:15:33] Lindsey Dinneen: Yeah. Yeah, that's so important, and I appreciate you saying it that way. I think intentionality is such a key component of leadership, and this is some of the conversations that I'm enjoying having lately is, h- and I'd love to get your input, is how do you go about intentionally creating the right team, the right vision, and the right culture to support the fact that you don't have to be surprised by things? You get to be happy, but you have the right framework in place. [00:16:08] Ofer Shalev: So I would say that in terms of the team, it was changed and replaced along the way. [00:16:15] Lindsey Dinneen: Mm-hmm. [00:16:17] Ofer Shalev: At the beginning... By the way, even today we have we have, we have twenty-four employees. Six of them are PhD Along the way, since we need people that know how to read articles, how to analyze article, et cetera. So I would say that we have in a, in a, in a company of about six, seven employees, three or four of them were PhD. There was a lot of self-learning to do. Later on, we start to make, "Okay, we have to develop. We have to build a product." So obviously, we, we, we mixed this team with people that came f- with some experience from the industry. Furthermore, experience from the medical device industry. Okay? So I would say along the time the, the, the population in New Phase become to be more heterogeneous. [00:17:08] Lindsey Dinneen: Hmm. Mm-hmm. [00:17:10] Ofer Shalev: Because really we-- you-- I mean, currently we have a product, so we need people about regulation, about quality, people that know very well engineering, people that have a idea about operation and not only researcher. But again, at, at the beginning, all, all our employee came from the... I mean, we, we, we, we re recruit about I think three or four PhD at the beginning to start with, and it will change along the way. Yeah. Now about-- you ask about leadership. So, I would say that I ca- I can see the leadership not only about, about leading people, but also about pushing your vision. Okay? Because again at the beginning, an idea of changing the cancer disease into a manageable disease, it was not so well accepted idea. Anyone ask about curing, but we keep saying, "No, there is no, there's no g- currently, there's not a real good chance of curing. Let's focus about prolonging life." Nowadays, it's common language. You can see from any, any drug company discuss the issue of manage- manageable disease. But when we start with this vision, it was very hard to convince people about it, and obviously many of them said in a very skeptical way, "You will not make it." [00:18:29] Lindsey Dinneen: Mm. [00:18:29] Ofer Shalev: So this part of the leadership as well, "Okay, I heard you. Let's, let's meet at the end of the day and we'll see what hap- who, who is the right one." So, yeah. So I would say that in our case, leadership is, is mainly to, to maintain the vision, to push the vision, to develop the vision. Partially it's about, a- about employees, sure, because at the end you have to recruit employees that will implement this vision into a technology, into a product But I would say that in a company like New Phase, the, the leadership is as more than 50% is about the vision. [00:19:11] Lindsey Dinneen: Yeah. Yeah, pushing the vision forward. I, I really appreciate that. I, you know, you had so many things at the beginning that you were talking about that I really appreciated. You talked about never giving up, overcoming difficulties, and loving challenges, and I think all of those are critical, of course, as an entrepreneur. But I'm also particularly curious about your h- you mentioned that you break down challenges into pieces and then rebuild, and I'm curious, where did that philosophy come from and how do you practically implement it? [00:19:48] Ofer Shalev: Frankly speaking, I don't know from where it came. No, I don't know. I mean, you know, with... Du-during the way, I, I, I had many, many chance to, to, to rethinking about some problem that we solved, and I asked myself, "How the hell we know what to do?" I, I don't know, frank- In, in many times, I would say that main-ma-mainly because we try to simplify the problem to pieces, and then we have a breakthrough id-idea about it. It is not-- I mean, the methodology is about breaking the problem into pieces. How to assemble it again, this is a breakthrough. I don't know how to explain it. [00:20:32] Lindsey Dinneen: Okay. [00:20:33] Ofer Shalev: really. [00:20:33] Lindsey Dinneen: Yeah, but do you find that maybe taking it apart and so probab- maybe part of it is, I wonder, you know, when you've got a challenge, it feels big and insurmountable, and you can't make any progress versus if you break it down and you go, "Okay, yeah, maybe this as a whole feels t- like too much, but what about this one little piece that if I can overcome this, then it will push me forward in overcoming the ultimate challenge?" I wonder if it's partly... [00:21:02] Ofer Shalev: It, it, it might be, it might be the situation. It's simple to, to deal with a, with a simple or with a, with a partial challenge, partial partial problems. And then it says, "Okay, I, I, I solved this issue. Let's try to solve another issue." And all of a sudden, you figure out that, "Hey, I have the full picture. I solve it." [00:21:23] Lindsey Dinneen: Yeah. That's, that's really cool. Okay. So, you know, you've had an amazing career, and not just within this space of course, but before that, and I'm just wondering if maybe especially along this particular journey with New Phase, are there any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time in the right industry"? [00:21:54] Ofer Shalev: Yes. I, I, you know, I, I think that it's... No, it will, it will par-- it will par-- I, I will answer you partially. I mean, once we decided to founder the company and that myself and my partner, Dr. Rafael Hof, we have after another company that we, we had, and we-- And when he came with this idea, I thought to myself, "If there are two entrepreneur worldwide that are able to deal with that problem, it's probably the two of us." Yeah. Ab-absolutely. Yeah. [00:22:31] Lindsey Dinneen: Yeah. [00:22:32] Ofer Shalev: Because the way that we work together, the w- the way that we each one of each one of us cover different area, how to build this kind of a crazy idea. I would say that really just only, you know, two people that are crazy enough and can work so well together can deal and succeed in this task. So this is the kind of, of, of of memory that I have from the beginning of the company. [00:22:57] Lindsey Dinneen: Yeah. I love that. That's, that's really cool. You, you know, you mentioned also at the beginning that some of your experience as a pilot was really critical in helping you learn different skills or disciplines that help you succeed throughout your career and today. Do you mind just talking a little bit more about some of the things that you still hold onto as really important lessons learned? [00:23:24] Ofer Shalev: Okay, know, to be in a, in a cockpit of a fighter i-- of a, of a fighter airplane, I mean, just ones that was there can, can understand what I'm speaking about. But it's a who- the whole way of thinking. So I would say that from time to time, when I have quite, quite a big challenge, I, I, I imagine to myself that I'm in the cockpit, okay? In order to, to think the same way that you used to think fifty years ago. Okay? Now with, wi-with, with regarding with regarding it to to some advice, okay? To to some to some other entrepreneur, let's call it this way. So, I would say that first of all, choose a real breakthrough idea. Not an idea that, okay that probably someone else did before or will do it after-- will, will make it after you. Try to find a real breakthrough idea to... Because, you know, at the end, you, you sacrifice a, a big piece of your life about it. [00:24:24] Lindsey Dinneen: Mm-hmm. [00:24:25] Ofer Shalev: So try to find something which is real, real something. This is one. Then you have to have a very strong backbone and remain committed to your vision. Yes, you might change the technology, that's okay, but you have to be committed to your vision. And furthermore, probably many times along the way, you will hear from people you will not succeed, it's the wrong way, et cetera, et cetera, et cetera. So nowadays, when I hear this kind of a voice, I say, "Why don't you open the startup of yourself? If you know it so well, why don't you open? Because you don't have the courage?" [00:25:06] Lindsey Dinneen: Mm-hmm. Mm-hmm. [00:25:08] Ofer Shalev: And yes, courage is, is, is, is another component which is very important to entrepreneur that choose a way how to change the world. [00:25:18] Lindsey Dinneen: Mm. Yeah. I love that. Thank you for sharing. Okay, so pivoting the conversation a little bit just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. Could be within your industry, doesn't have to be. What would you choose to teach? [00:25:40] Ofer Shalev: I don't know how to do it, but I will say it in other ways. I probably to, to, to, to teach people how to avoid or what to do while you are in a dead end. [00:25:52] Lindsey Dinneen: Hmm. Okay. Do you wanna elaborate a little bit? 'Cause I'm curious. [00:26:00] Ofer Shalev: I think that, that, that your ability really to believe in yourself is a key factor. [00:26:05] Lindsey Dinneen: Mm-hmm. Mm-hmm. [00:26:06] Ofer Shalev: Your ability to, to free your mind, not to focus about the current problem, but to free your mind, going outside and try to find some other idea is quite important one. [00:26:18] Lindsey Dinneen: Yeah. [00:26:18] Ofer Shalev: Yeah, those kinds of things. Probably we have to think about this kind of a masterclass. [00:26:23] Lindsey Dinneen: That would be a great masterclass, yeah. Okay. All right. [00:26:27] Ofer Shalev: By the way, I, I truly believe that in order... I mean, at least that's what I'm doing. But I, I besides that I'm working very hard, I try to read many books. It might be biography, it might be historical novel, it might be by... it might be a thriller. I try to be very, very diverse in what I am reading. I believe it's, it's just fruitful my mind, and not to focus about only about some scientific articles. [00:26:56] Lindsey Dinneen: That's... I love that. That's great. All right. And how do you wish to be remembered after you leave this world? [00:27:06] Ofer Shalev: Well, it's not something that I particularly concerned about it, truly. I don't, I, I don't... I, I, I will say fir- I will say something else. I truly believe that true leader are not focused about what people will remember about them. It is important that the vision will stay. It's important that a father and mother, or children that have cancer in the family will be able to live longer life with a better quality of life. It's much more important if people know, "Hey, Ofer Shalev bring this technology to the market." [00:27:45] Lindsey Dinneen: Mm-hmm. [00:27:46] Ofer Shalev: That, that the way I see it. I mean, I don't care too much what will people remember after I leave this world. [00:27:53] Lindsey Dinneen: Yeah. No, that's, that's beautiful. I love that. Okay, and then final question: What is one thing that makes you smile every time you see or think about it? [00:28:04] Ofer Shalev: Well, that is very, that is very easy. You know, when you have so many, so many grandchildren, so, to hear the questions "Why did, why did it happen?" "Why the bird is flying so high?" The, the truth and simplicity of children and the way that they are thinking, that's really something that make, I think, everybody smiling about it. [00:28:28] Lindsey Dinneen: Yeah. That's so fun, and I couldn't agree more. I I have a few nieces and a nephew, and getting to, to sort of see the world again through their eyes and perspective is just really fun. It's just, it's joyful. [00:28:44] Ofer Shalev: Yeah, it's a great chance to hear about a simple way of, of how the world should, should be. [00:28:49] Lindsey Dinneen: Yeah. Curiosity. I love the never-ending curiosity. [00:28:52] Ofer Shalev: And asking many questions. It's very-- I mean, asking question is, is a great, is a great benefit. [00:28:58] Lindsey Dinneen: Yes. [00:28:58] Ofer Shalev: Ask as many questions as you can. [00:29:00] Lindsey Dinneen: Your whole life. [00:29:01] Ofer Shalev: Yeah. [00:29:02] Lindsey Dinneen: Yeah. Excellent. Well, this has been such a great recording. I really appreciate you sharing your your vision especially about New Phase and where you hope that the company will go and, and the lives that it'll impact. And I know you're well on your way, and I just wanna thank you for not listening to the people who said, "This is not gonna happen," or were trying to discourage you. I'm just so thankful that you're doing what you're doing. And we are honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support. So, really appreciate you being here today and just really appreciate everything you're doing to change lives for a better world. [00:30:00] Ofer Shalev: Thank you very much, Lindsey. [00:30:02] Lindsey Dinneen: All right. You too. Bye. [00:30:04] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Dave Rosa shares how a lifelong drive to help others and his own health challenges led him into 32 years across orthopedics, cardiovascular, and neuro. Dave walks through his path from early marketing roles to becoming a CEO, and explains the innovation behind NeuroOne’s electrode platform designed to combine diagnosis and treatment in a single procedure—starting with epilepsy, expanding to trigeminal neuralgia, and now targeting lower back pain. He also discusses early work using the same technology for precise drug delivery to the brain, including a program focused on glioblastoma. Dave closes with leadership lessons on vision, culture, learning from mistakes, and giving back.    Guest links: https://nmtc1.com/ | https://www.linkedin.com/company/n1mtc/ Charity supported: Opportunity International Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 086 - Dave Rosa [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Dave Rosa. Dave is an entrepreneur with three decades of experience in the medical device industry, spanning a variety of technologies and products. In addition to CEO roles with early-stage medical device companies, Mr. Rosa's background also includes senior roles with C.R. Bard Inc., Boston Scientific Inc., and St. Jude Medical, where his responsibilities included marketing, product development, and business development. He has been named as an inventor on multiple medical device patents, serves on seven corporate boards, and has raised 200 million in the capital markets. Well, Dave, thank you so much for being here today. I am absolutely delighted to have you on the show. [00:01:33] Dave Rosa: Well, thanks for having me. [00:01:34] Lindsey Dinneen: Yeah, of course. I would love, if you wouldn't mind, by starting out and just telling us a little bit about yourself, your background, and what led you to medtech? [00:01:45] Dave Rosa: Yeah. So, born and raised in a small town called Richport, Pennsylvania, outside of Philadelphia. And really was in love with the medtech industry from the time I was much younger. So I, I have been in medtech now, it's going on 32 years and that's everything from large medical device companies to, to startup companies. I've been in so many different areas of medtech. I've been in orthopedics, cardiovascular, and I mean everything involving the heart, I've been in it in some way, shape, or form, a-a-as well as neuro, which is what I'm in now. And, and I think, you know, why did I get into medtech? I think this all goes back to when I was a little kid. You know, I, I was the little kid that was walking street people to my house and bringing them into my home for my mom to make a meal. I don't know that she always appreciated that me doing that, but, but there, there were more than enough times where she sat me down and I was maybe only four or five years old, and she's like, "Honey I, I, I know you wanna help people, but you can't bring everyone home." And I was like, "Oh, oh, you know, okay, Mom." Of course, until the next time. But, you know, I think it started at an early age and, and really has carried through you know, the rest of my career [00:03:07] Lindsey Dinneen: Yeah. Yeah, okay. So you've always been interested in helping people, and you've had a really nice variety of experiences within medtech. But tell us about your path from that early just interest and care in, in people and their wellbeing, to perhaps your educational journey and maybe, like, the first little bit of your career that led you to where you are now. [00:03:32] Dave Rosa: Yeah. So, in high school I was involved in sports and, and even prior to high school, and I had so many physical issues. So I had initially a shoulder problem that was I'll, I'll say pretty complicated, at least back in those times. And what I found is by the time I got to college, and, you know, I'm still trying to figure out what I wanna do with with my life and what career I wanna take. I, I was actually in chemical engineering, but came, came to the conclusion that I hated chemistry, which, which didn't help things out. And, and I really knew, you know, my, my passion was on the medical side, and a lot of it, you know, was driven because of my own issues, my own shoulder issues, because it really put a damper on, you know, any, any potential I had at especially playing baseball. So, so, i- in college, I went to Drexel University, there really wasn't a course for biomedical, undergraduate biomedical engineering that was, like, a graduate program. And, you know, I, I decided that I would take courses in electrical engineering and a program called commerce and engineering, which kinda merges both the business and engineering side of the equation. So, I, I actually started out not in medical. I was in electrical engineering, and I was probably one of the worst electrical engineers working at Westinghouse at the time. And I remember one of the managers saying to me, he's like, "You know, all, all the other engineers and marketing people really like working with you. Why is that?" And I said, "I, I really don't know other than, you know, I've always been a passionate person about whatever I'm doing." So, you know, so at that point, I started thinking that engineering was not the path for me, that you know, that I was really more, much more passionate about medical because it was impacting my life with my shoulder. And then by that time, you know, my knees and everything else started to go as well. But I graduated with a degree in commerce and engineering, and then after working a few years in electrical engineering for Westinghouse Electric I just started knocking on doors because I, I really-- my passion was, you know, helping others, and I wanted to be involved in an area that might help me being orthopedics. So that, that's kinda how I got my first job, knocking on doors, and Stryker Instruments decided they would take a chance on me, and that, that was kind of the beginning. [00:06:12] Lindsey Dinneen: Very nice. And so when you found medical device, was it this really exciting moment of realizing that it could marry your interests in engineering and your desire to help people? Was that like just this cool moment of going, "Oh, wow, like I, I can do both"? [00:06:31] Dave Rosa: Yeah. I, I, you know, I remember actually praying about this, like, "What am I supposed to do?" Like, you know, and, and "How do I go about this?" And I don't know, you know, it, it, it brought back some memories you know, of when my father was you know, was at the end of his life, and he was this stern Italian man. Never, you know, never-- there, there was no discussion about feelings or anything like that. It was like, "You do what I tell you to do. You, you talk when I tell you to talk. Otherwise, you know, you say nothing." So my, my dad's literally on his deathbed, and he says to me, "You know, I, I really wanna thank you, son, for taking care of your mother and I all these years with, you know, medical decisions." And he said, "You know, you, you always were helping people from the time you were a little boy." And it actually stunned me that my dad, who never appeared to be paying attention to anything regarding me, was like, "Hey, you know, you, you know, you really cared about helping people, not just us, but, you know, this, this goes back to the beginning for you." So it, it was also more of a reinforcement of like, "Yeah, I've, I've really gotta be in medtech, and I'm gonna start with, you know, how I can help my own issues and/or, you know, family's members' issues that they may have." [00:07:52] Lindsey Dinneen: Mm-hmm. Yeah. Yeah. I think sometimes we don't realize the impact that we're making at the time and being able to just do what we feel is right and, and what we know helps others can actually make an impact, and then hopefully we get those opportunities like you got with, with your father to s- realize eventually, "Oh, okay, yeah, I, I am, I am on the right path doing, doing the right thing at this time." So yeah, it's great to have those moments of reinforcement, but. [00:08:26] Dave Rosa: And if you fast-forward, you know, to something again, just more reinforcement, although it's much later in my career and I've had other moments like this, but this was just last month. I was at, at a memorial service for one of the physicians that used our product to treat a, a young lady, she was 17 years old at the time for epilepsy. And so the doctor that performed a procedure on her had a tragic accident, passed away, and we were all at this memorial service for him. And the father along with the mother and, and this young lady who's now in college, they came up to me you know, we were, you know, just chatting about how unfortunate the situation is. And when I got ready to, you know, go back to the service he said to me "Sir, I, I just wanna thank you for giving my baby girl her life back." And I mean, those kinds of things, when, when people say those things to you, and like I said, it's happened more than once, and, and it's because of something, you know, that you've you know, committed the, the company to accomplishing, and then you see results like this, there's nothing more rewarding than that. [00:09:39] Lindsey Dinneen: Yeah, of course. Yeah. Thank you for sharing that. So, all right, so in fast-forwarding a little bit you, you started in medtech with Stryker, and then what gave you-- and, and there's probably maybe some things in between-- but what gave you the the idea for what you're doing now? And can you just take us along that journey from starting out in medical device to where you are now, including that just pathway to even, to even higher roles in leadership and that learning curve as well? [00:10:12] Dave Rosa: Yeah, that's-- boy, that's a long story when you've been in it for 30-some years. You know, I, I started out in marketing. I always liked the interaction between customers, meaning, you know, physicians, patients, when, you know, we had the opportunity to, you know, to speak to the patient. And then, you know, I, I I would like to think that maybe some of my decision-making and, and some of my ideas, you know, led to success in some of these companies. And you know, I think upper management you know, wa-was able to identify that I might have some of the, the qualities that they were looking for really in the next generation of leaders. And this goes back to you know, my, my first job in the cardiovascular industry. Gosh, this was in 1995, so, about 30 years ago with Boston Scientific. And I was able to go from a Product Manager to a Director of Marketing. And I was there for a total of about four years, and I, I really enjoyed the strategic part of the job, and I, I wanted to be more involved in that. And I got an opportunity to go to a startup to run sales and marketing also in the cardiovascular space. And that was a, a great experience because, you know, in smaller companies, and this, by the way, was my first opportunity in a smaller company, you know, you, you have to wear a lot of hats. And I liked, I always liked to be more hands-on and still am, to be honest, and, you know, th-this gave me an opportunity to really you know, get involved in more than just what the job detail or the job description called for. And, you know, the-these things all, sometimes, you know, require some luck but definitely, you know, the right timing. And an opportunity in the startup company that I left Boston Scientific for became available at the CEO level, and the the investors-- the company was funded by venture capitalists-- met with me and said, "You know, we, we think you can take the company to the next level." And I think that was back in 2003, and pretty much been a CEO ever since then. But I, you know, I think a lot of the success comes from and confidence from, you know, the, the hiring companies. I, I think what people notice about me is my passion, my, my commitment, and, and probably the fact that you know, I, I think one of the things I'm strong with is developing a, a, a vision. I mean, that's, that's something that I think is really critical with leaders is that you, you've gotta develop a vision for the company, a strategy for the company so that others can understand what the goals are. So that, that's kinda my path. It's, you know, it's, it's I would say every four to five years I've had an opportunity to either start a company or run a company. And then NeuroOne, which is, you know, my current company, I was actually retired when I was approached by a few individuals who had this idea. And what started out as me just, you know, helping them turned into "Gosh, we would love you to run the company." And I really thought there was an opportunity there, you know, to help people who suffered from these neurological disorders, primarily brain-related disorders. But, you know, that, that vision has kind of expanded beyond just the brain into other areas of the body. [00:13:56] Lindsey Dinneen: Wow. Yeah. Okay, yeah. I appreciate you sharing more about your journey. I love the fact that you're both an engineer and you have this creative side with marketing, and you're able to marry all that together. That's, that's really cool, and gives you such a unique perspective on, you know, I would say product development and then commercialization. But okay, so let's talk about your company now, and what are you excited about? What are some of the innovations coming out of it? You mentioned that it sort of s- it started in one place and one focus, and now we get to see it expanding. And so I'd just love to hear all about your company as well. [00:14:33] Dave Rosa: Sure. So, we started out with the intention to develop this electrode technology, and initially it was primarily to be used for brain-related procedures for patients, initially at least, that were suffering with epilepsy. And this, this technology, the, the idea was "Let's combine functions with this" in that it, it, it would have the ability to perform a diagnostic function. And for these patients, the diagnostic function was finding the area in the brain that was triggering these issues. And then once you were able to accomplish that, then using the same device, destroy that brain tissue that was causing the problem in an effort to eliminate the seizures that patients were having. So that, that's kind of where we started. We, we are selling that technology. We have a distribution partner, Zimmer Biomet, that is our exclusive distributor for that technology, and we've had great success in treating patients. You know, the story that I told about the father you know, who thanked me for getting his daughter's life back, that's what that technology is used for. And the-- really what patients had to face before this technology was available is they would have to have a very invasive surgery just for the diagnostic part of the procedure. So the part where you're just trying to identify the problem area, that was one surgery. And we're, we're talking about, you know, drills that are drilling holes, you know, through the skull with these devices being placed in the brain. And then once that part was done, the patients would go home, and they would be scheduled for a follow-up procedure where they would have to come back again, have an invasive procedure in-into the brain, and then that, that second procedure would be the one where they would eliminate or destroy the problematic brain tissue. So if you're a patient, two invasive surgeries, two hospitalizations, two separate devices, and we said, "Why can't you do it with one?" And, and that's, that's where we are. We then more or less leveraged that technology to treat a a condition called trigeminal neuralgia, which is this excruciating facial pain that patients will experience. And it, there-- it's very well known to carry a a high rate of suicide because of how painful this condition is. But we were able to leverage the same system and provide the neurosurgeon you know, with, with a very unique tool to treat that condition. We also-- what I'm also excited about is these-- the, the same platform we're using now to develop technology to treat lower back pain. There's different types of lower back pain. We, we happen to be focusing on two. One that involves issues with the basivertebral nerve, which is a l- a nerve in the lower spine. And then the more common back pain where you have pain that's traveling down the leg, that's sciatic nerve pain. So we've been able to use the same electrode to to develop technologies, unique technologies that would be able to treat that condition. And then finally, drug delivery. These electrodes have a hollow center and we've been able to demonstrate in animals so far that not only can you use it for diagnostics and stimulating through, but you can also deliver therapeutic agents directly into the brain, specifically where you would like to deliver them. And we, we've initiated a program to try to improve really the care for patients that suffer from glioblastomas, which are those brain tumors that carry high rates of mortality. [00:18:45] Lindsey Dinneen: Wow. Wow. Well, there is an incredible amount of innovation coming out of the company, and I'm so excited to follow along and just see all of the difference that you're gonna make in patients' lives. So gosh, first of all, thank you for what you're doing. I, I'm curious, you know, you, you've had such a great career and so many different opportunities to grow into more and more leadership roles. And I, I'm wondering, first of all, what your own leadership philosophy is, sort of as a whole, and then maybe some examples of both good and not as ideal leadership that helped to shape it. [00:19:28] Dave Rosa: Yeah. So, I mean, for me, you know, the, the people that I've always looked at that I think are great leaders are, are those people that can communicate a vision and, and really instill a passion to inspire others in the company to have the same sort of passion to achieve this, this overall vision or this overall strategy. And, you know, I, you know, I-- there, there have been clearly people that I've worked for in my life that I've said, "Gosh you know, they, they really were inspirational to me to be better," not just I would say as a leader, but just more effective overall. And, you know, I, I, you know, I, I-- when I look at my own areas that when I think about leadership and what I can do to, to be more effective, you know, I some of the areas that I've personally looked at i- are things that can make the company more efficient. And artificial intelligence is probably the one that gets, you know, the most attention today. And, and I'm looking to using it, and took a course in this actually to, to really become more efficient and help the company be more efficient in, in developing these technologies and getting them to market as, as quickly as possible. And, and I think, you know, for myself, I'm, I'm very fortunate to be surrounded by a board of directors that I look at that I think have excellent leadership qualities, and it's, it's really, you know, meeting with them on a... and, and just talking to them on a fairly regular basis, picking their mind to see how they would handle things because, you know, I'm, I'm really the, the product of stealing ideas from other people that, that I think you know, have worked well and led to the success of companies and people that they've led. So it's, it's not necessarily taking a course on leadership, but it's surrounding yourself with people that have been successful in leading groups and, you know, getting ideas from them on how to be more efficient, whether it's, you know, taking classes you know, in, in things like AI or, or just, you know, learning from their own success as to how to inspire people to, you know, to really finish the goal for whatever that goal is. [00:21:58] Lindsey Dinneen: Yeah. Yeah, and speaking of inspiring people, how do you as a leader intentionally help shape the company culture that you feel is best for, for people to thrive in? [00:22:13] Dave Rosa: Yeah. So I've, I've always been of the mindset that companies that perform the best utilize ideas that others on the team have. So there, there are, I, I'll give you a great example. I-I find that people that come from big companies have more of a mindset of execution, meaning, "So whatever the boss tells me to do, I do and I'm, I'm not gonna challenge them." So it's, it's one more of, "I, I find out what I need to do and, and and I execute that." You know, in, in our company, one of the things I try to foster is that it's okay to have a, a different opinion. We're all here, you know, trying to be successful, and none of us have all the answers. Now, there's gonna be times when we as a, a team just can't agree, and when those times occur, then, you know, the, the CEO is going to have to make the final decision because that's in my mind, that's, that's really one of the roles of the CEO. But I can tell you, in our company and in other companies I've been in, a lot of the, the great ideas on what to do, you know, have really come from others. They haven't, they haven't come from me. I'm-- I may be setting the overall vision, but sometimes, you know, you, you take a small detour because someone in the group who wasn't afraid to speak up, you know, has an idea or a thought that you know, makes the, the outcome more successful, whether it's shortening the time or coming up with a different idea, a different concept. I constantly try to hi- hire people that have skill sets that I don't have. So for example, I recently, within the last two months hired a guy that had great experience in the pharma space and really how to navigate that space and understands the, the therapies that are out there. And in a very short period of time you know, I realized, "Gosh, this guy, you know, knows so much more than I know and I'm gonna learn a lot from him." So I think it's, it's, it's really empowering the people that you hire, you know, to express what their thoughts and their ideas are because I don't care what CEO you're talking about, none of us, you know, have all the answers. [00:24:33] Lindsey Dinneen: Yes. And recognizing that is, is definitely, I think, key. I think a lot of the leaders that I've been talking to recently talk about exactly what you've mentioned. It's, it's recognizing that y- you know, you, you, you do have your blind spots or your just, your areas of weaknesses, and that's okay 'cause we all do, right? But as long as you're willing to say, you know, "Okay, this might not be my area, but I trust the person whose area I know it is," then, then that's just such a great way to, to handle that and empower the next generation of leaders. So yeah, I love that that's your approach. [00:25:10] Dave Rosa: I also, you know, I, one other area that I think is also critical, and it goes back to what I said about individuals that I've met in larger companies, and I experienced this when I was in a larger company as well. You know, the focus becomes not making a mistake. And and, and it's because you know, the, these employees don't wanna make a mistake that's going to cost them their career in that company. So the safest thing to do is to do what your supervisor tells you to do, as opposed to take a chance and, you know, offer a different idea or a different concept. It's seen as risky and it's because there's this fear of making a mistake. I think it's smaller companies, especially in companies that I've run, you know, my, my philosophy is it's okay to make a mistake, but let's not make the same mistake more than once. I mean, they're, they're there to learn from. So let, let's, let's be smarter the, the second time, you know, because of that experience. But if people are afraid to make mistakes, you'll, you know, you're, you're never gonna get different ideas or different concepts you know, out, out, out amongst the group because of the fear of making a mistake. [00:26:26] Lindsey Dinneen: Mm-hmm. Right. Yeah, absolutely. Providing that, that opportunity and I, I know it's a bit of a cliche, but the, the idea of a safe environment at least to present those ideas and potentially counter opinions, and that's where creativity thrives is when you can iterate and bounce ideas off each other and, and come up with something that's, you know, you couldn't have done by yourself. Yeah, I love that approach. [00:26:50] Dave Rosa: Yeah. [00:26:51] Lindsey Dinneen: Yeah, so okay. This is, this is marvelous. I really appreciate all of this so far. But I'm gonna pivot the conversation a little bit just for fun. So imagine that you were to be offered a million dollars to teach a master class on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach? [00:27:13] Dave Rosa: Yeah, this this doesn't fall under maybe necessarily, you know, a a class that you would see in a, a normal curriculum. But, you know, I-- it's, it's something that I've tried to talk to my own children about, and that's teaching them about being thankful for what they have and also, you know, giving back to others that are less fortunate. I-- you know, there's a saying that, that "comparison i- is the thief of joy." You know, the-- I, I think the human race in itself just has a way of always dwelling on, like, what we don't have as opposed to being, you know, thankful to God for all that we do have. And I, and I, I, you know, I, I really think that o- one of the things that I've tried to instill in, in, you know, my, my children, and now they're all grown, is you gotta be grateful for what, what you have, but you gotta find ways to find common ground with people and, and be sure to give back to others that, you know, haven't been as fortunate as you. I, I think that's, you know, what this world should be more focused on than, you know, all, all you hear about today is what we don't agree with and why this side or that political party, you know, is ruining the world. I think if we all focused a lot more of our energy on helping others you know, the, the world would be and this'll sound cliché, a much better place to live in. So if I could teach a course on instilling thankfulness and and the importance of helping others, that's what I would do [00:28:49] Lindsey Dinneen: Yeah. No, that I couldn't agree more. Gratitude and giving back are, are key and, and the world needs more of it, so I love that idea of a masterclass for sure. And how do you wish to be remembered after you leave this world? [00:29:06] Dave Rosa: Yeah, it's-- it kind of goes back to, you know, what my dad said to me, and that was you know, as, as a, a youngster and, and that is, you know, my, my passion and interest to really help others. Yeah, that sums it up the best. [00:29:23] Lindsey Dinneen: Yeah, absolutely. Okay, and final question: What is one thing that makes you smile every time you see or think about it? [00:29:33] Dave Rosa: I, I would say you know, there, there are people that will doubt you and put you down in your career and tell you why, you know, you'll never do this or you'll never do that. And I can honestly say I never thought, you know, I would ever stand in Nasdaq, you know, on Wall Street and take a company public. And, you know, the, the one thing I, I do kind of cherish is I've been able to do this twice, but the first time I remember standing on the stage before the activity started at Nasdaq and one of the people in the company said to me, they said like, "You know, you just had this smile, you know, on your face. You know, it looked like you were thinking of something." And I said, "Yeah, you know, I, I was thinking about all those times that people told me that, you know, I, you know, I would never be successful in my career," and you can define success in different ways, but it, it kind of made me feel good. It was the first time I think I really felt, you know, proud of myself that, "Wow, you know, I'm, I'm one of a very small percentage of people that have been fortunate enough to, to actually you know, take a company public." So, it always makes me smile. [00:30:52] Lindsey Dinneen: Yeah. Yeah, absolutely. Great answer, and that, that's a really cool moment to reflect back on. Well, Dave, this has been a great conversation. I so appreciate your willingness to, to talk with me today, but also to share about the, the incredible work that your company is doing and your heart for helping people from the very beginning of your childhood, and obviously a huge passion of yours throughout your life. And we are so honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which works to end global poverty by creating and sustaining jobs while also providing small business loans, savings, insurance, and training to more than 14 million people in the developing world. So thank you so much for choosing that organization to support, and thank you for everything that you're doing to change lives for a better world. [00:31:47] Dave Rosa: Well, thanks for having me on the show as well. [00:31:49] Lindsey Dinneen: Of course. [00:31:51] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Anastasia Mironova is the founder of UpLevelMedTech, a leadership development and executive coaching practice focused on shaping the next generation of medtech executives. Anastasia shares her path from joining Medtronic as an MBA intern to building a career across marketing, strategy, sales, and M&A, and the pivotal moment that cemented her purpose. She breaks down the core themes she sees in leaders at every level—team effectiveness, operating with GM-level ownership, and influence without authority—and explains how “leadership by subtraction” and time inventory create the capacity for strategic impact. She also explores how music shaped her leadership through listening, pausing, and performing under pressure.    Guest links: www.uplevelmedtech.com Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 085 - Anastasia Mironova [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of the Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Anastasia Mironova. Anastasia is the founder of UpLevelMedTech, a leadership development and strategic advisory firm dedicated to shaping the next generation of executives in medtech. Through a blend of executive coaching, strategic advisory, and custom leadership programs, she helps senior leaders and teams elevate their influence, decision-making, and organizational impact. She is a passionate advocate for advancing women in leadership and brings two decades of lived experience navigating corporate growth, career transitions, and motherhood with authenticity and humor. Known for her relatable approach and her ability to make leadership growth feel both practical and empowering, Anastasia helps leaders show up with clarity and confidence in complex environments. When she's not coaching or facilitating programs, she loves spending time with her husband and daughter, often recharging at a beach somewhere and supporting mentoring initiatives that help women lead boldly and thrive in their careers and lives. All right. Well, welcome to the show. Thank you so much for being here today. I'm, I'm really excited to speak with you. [00:01:55] Anastasia Mironova: Thank you for having me. I'm excited also. [00:01:58] Lindsey Dinneen: Awesome. Well, if you wouldn't mind starting off by just sharing a little bit about you, who you are, your background, and what led you to medtech? [00:02:08] Anastasia Mironova: Oh my gosh. My name is Anastasia Mironova, and I'm the CEO and founder of UpLevelMedTech. We are the leadership development and executive coaching practice focused specifically on medtech, but I have not grown up around medtech at all. You probably hear that from other guests, I'm assuming, quite a bit. But I was born and raised in Kazakhstan in Central Asia, and I kind of grew up more around music and entrepreneurship and totally did not know anything about medtech. I came to US in early 2000s to do my MBA program, and one of my classmates was, at the time, working for Medtronic. And when I was finishing my MBA program, she said, "You know, we're hiring for a variety of marketing roles, including an intern, and I was thinking maybe you should apply because you have some of those skills." And I said, "Sure, I, I'm interested." And so the rest is history. I joined as an intern working for Medtronic and eventually worked my way up into product management roles and then global marketing, marketing and strategy, marketing strategy and sales, and then added M&A components to it. So loved it, and I very shortly thereafter, there was a situation that made me completely fall in love with the industry. And I would say that what I really appreciate about it the most is just how much purpose there is behind it, and that's what really connected me to it, and also just how much innovation is being brought forward because I come from a place that didn't necessarily have a lot of innovation readily available, you know, at the speed that we're producing it here. And so I, I really appreciated that, and that's how I-- that, that was my journey in medtech up until I then became a, an entrepreneur and opened up my own business. [00:03:51] Lindsey Dinneen: Awesome. Okay, well thank you for sharing. There's so much I wanna dive into, but you said you did grow up around maybe not medtech, but entrepreneurship and leadership and things like that. Do you mind sharing a little bit about that and what maybe intrigued you? Because obviously you've become not only an incredible leader yourself, but you are coaching other leaders too. [00:04:11] Anastasia Mironova: Yeah, sure. It's, it's a really good question. I grew up around my parents' little, I call it mom-and-pop loving business. That business didn't start until after the wall fell and, and, and all of that, but because the business was so tiny, everybody was involved, and I was very much spending a lot of my time around that. And my mother was my early impact on how I was shaped as a leader later on. Unbeknownst to me, I would say she was what you and I would describe a servant leader today, probably long before that term was coined somewhere in a book or in a business school. But what it really taught me was one thing, which is you're not bound to any specific functional area. You are in the business of something, whatever your business is. And so it taught me to think more broadly and to think like a business person, and I would say, again, I was very unconscious to that at the time. I was just doing a lot of things, helping out, having fun, sometimes thinking about how I absolutely don't know what I'm doing, you know? But then later on, I became more and more self-aware about the fact that how much that business thinking actually helped me to succeed later on as a leader and, and help other leaders grow. [00:05:29] Lindsey Dinneen: Yeah, and I'm curious about that aspect. So you, you said it was lovingly a mom-and-pop place, which is wonderful, and, you know, you said sort of everybody was involved, and I feel, feel like that is a very common theme. And so one of the things that I'd be curious to have your take on is something that I discovered owning my own dance studio is there were, there were a lot of moments that were really fun, right? And you, you got to kinda show up in the community, and you, you had a business, and that's, that's a fun thing to do. But, you know, on any given day, I was everything from the CEO to the janitor, and everything in between. And I think that's a wonderful thing to experience as a leader, but I'm curious as to how that experience probably shaped your own style of leadership beyond being able to observe really good leadership up close and personally. But I'm just kinda curious how that, how, how sort of having a take in all the different aspects of the business may have really helped shape you. [00:06:27] Anastasia Mironova: Yeah. It, it, it's really kind of fundamental when I think about it, 'cause my mom said exactly the same phrase that you just mentioned. She told me always, "You have to be able to get along with everyone equally and treat everyone equally with respect, whether it's a janitor or your CEO, and your ability to get along with every level of the organization is what's going to shape the success." And, and she was very much modeling that behavior. But where I feel it shaped me was that when you work in, in medtech in particular, it's very cross-functional, right? So when you work in a particular area, say I was in marketing in early, in early days, I didn't think of myself as a marketeer. And, and what that meant for me is certainly I would focus on what I needed to do and my goals and our functional area imperatives and all of that, but I always was curious about how does the rest of the business work. And so I didn't think of myself as "I'm a marketing leader." I thought of myself as "I'm a business leader." And when you remain curious in how other aspects of the business work, how it all comes together, what are the macro trends? You know, what do the customers want? How are people compensated? How does the innovation pipeline get shaped? All of those things working together helps early on to make better decisions in your own swim lane. And it kind of like, it shaped me as a leader because I felt that it helped me to make better decisions in larger context in mind. But also it helped me to relate, to relate to a lot of people in a lot of different functional areas, and not assume what their life was like and what their day-to-day was like, but be curious about it. So I would say that definitely both of those things shape how I saw business as well as people in it, if you will. [00:08:18] Lindsey Dinneen: Yeah, I love that. I love the idea of curiosity and being willing to have conversations, meet other people, learn different aspects of the business, 'cause you're absolutely right. The only thing it can do is help you better understand your lane in relation to other people's lanes. And I'm wondering if part of that was also learning how to kind of to, to speak the language of other people's areas of expertise a little bit, in the sense of you're probably going to have a little bit of a different explanation for, say an upcoming project you wanna launch, say, like a, a marketing campaign to the CFO than you would maybe an engineer. So I'm curious how you, how that ha- unraveled for you. [00:08:59] Anastasia Mironova: Oh it was quite a journey. So earlier when, when I first started in medtech, and I was probably on my second role, I had a, a tremendous boss that was very visionary and, and she believed in talent development very much. And she said to me, "You need to go and probably get even more training in influencing and influencing skills." And I was like, "Wow, I would love to do that. I love everything that has to do with human psychology, behavioral, you know, psychology." And so she actually sponsored that, and I was able to do that. And what I quickly found was that the way you position your message and the way you deliver your message and how you influence different people varies drastically. And that really helped me later on as a leader to advocate for my team. I felt like at minimum, the influencing skills and the ability to relate to different people from different walks of life, it helps you to advocate for yourself and for your own initiatives and for whatever you might be focused on. But for leadership, it definitely helped me to be heard as a leader and advocate for my own team later on. And I also felt like other leaders were telling me, "You really understand what it's like to be in our shoes," and therefore were more willing to listen to what I had to say. So it's, it's such a counterintuitive thing at times, but I do believe in this concept of it is our job to inform ourselves of our conversation partner and not the other way around. And it, it works. It's very effective. [00:10:38] Lindsey Dinneen: Yeah, that's, that is, that is incredible and such a great skill set to have and to pass along, and I really love your point about advocating for others as well, in addition to advocating for yourself. And so I know one of the things that you do brilliantly now is to help people who are potentially interested in taking that next step in their own leadership journey, whether they're interested in, you know, going from, let's say, director to VP, VP to C-suite, and things like that. So I was just wondering if you could share a little bit about how you made this successful for yourself, because you mentioned on, on your LinkedIn profile that you didn't work-- It's not like you were working crazy hours, or you were doing all the right things. And so I'd love to hear about your journey and then how you help others too, through their journeys as well. [00:11:27] Anastasia Mironova: Yeah, certainly. I'm thinking about back when most of my career happened, probably while I was very much navigating the demands of everything all at once, the demands of young family or having young family at the time, you know, parents and, and everything that we normally have on our plate. And I firmly believe that as a leader, you have to be very, very clean and clear on what your one or two things are that are super strategic in your world that only you can really do and drive, and this is your primary role. And so one of the ways I did that is I, I definitely was very, very intentional about how I spent my time, and I did a process once a month that had to do with my inventory, time inventory, believe it or not. And I would do it on the plane or, you know, on, on the ride to, to, you know, a, a seminar or something or a meeting, and it really helped me to hone in on these are the things that only I can really ensure to drive, and the rest belongs to my team so that they can shine and they can also, you know, we can be effective together. One of the things that I find the hardest is that people graduate from execution to that strategic impact, and it's hard to do that. Most of the time when I help my clients, the, the challenge is not the capability. It's not the skill set. I work with tremendously talented people. It's the capacity. It's the creation of that leadership capacity, and that takes what I call leadership by subtraction. You have to subtract something to create that space for your strategic impact, and that's what we work on often together, but that's what really truly helped me to be successful, is leadership by subtraction and inventorying it. [00:13:20] Lindsey Dinneen: Yeah. Okay, great. Well, yeah, th- that's great because I'd love to learn more about your company now how you work with people, and kind of where you find perhaps some of the, the hardest things as, as you're growing in your career and your leadership responsibilities increase. So what are, what are some of the common things that you see that don't work well as you're trying to continue to grow in your, in that way? [00:13:46] Anastasia Mironova: For me or for my clients? [00:13:48] Lindsey Dinneen: Let's talk about for your clients. [00:13:51] Anastasia Mironova: Okay. So for my clients, I would say there are definitely very common themes as I see it. It's interesting to me because when I first opened up my business, I had this theory that the kind of challenges that people maybe at an individual level will face might be drastically different from those that are faced at the executive level. And I quickly learned that the challenges are all the same. The way they show up in your day-to-day life may be different, but the challenges are all the same, and they have to do oftentimes with three things. Do you really get laser-focused on how effectively you manage your team so that you and your team can elevate? The second area that's probably by far the most common is, are you operating at that GM level? Even if you're individual contributor, are you thinking from an ownership perspective like an owner would in a business versus a particular title or a particular role in, in honing in on that business, business acumen and the one that crosses all lanes, all company sizes, I would say all teams, all functions is, is influencing skills and presence. How do you show up in a way that honors other people but helps you to move both business and people forward and you have absolutely no authority over them, right? So it's that influence without authority. These are very, very for like front of mind for a majority of the teams that I work with. And I'd say one of the ways to probably, you know, deal with that or address that is, is definitely to be very intentional about development. So it's not just here and there or, you know, as time permits, but as, as the companies become more intentional about the development, the more capacity they create. I definitely believe that our future is not, not in necessarily having high potential development, but high capacity development. [00:15:55] Lindsey Dinneen: Hmm. Yeah. [00:15:56] Anastasia Mironova: If that makes sense. [00:15:57] Lindsey Dinneen: Yeah. So how, how can we encourage companies to prioritize this? 'Cause I, I agree with you that the development all along the path is really important, and I know a lot of people take very personal ownership of that, and they do a lot of their own you know, training and things like that, and coaching. But, but what about from the perspective of a company? How can we encourage companies to be more involved and to understand the importance of the ROI associated with it, just to be frank? [00:16:27] Anastasia Mironova: Yeah. Yeah, for sure. And that's the conversation where I would say the CHROs, the people leaders, are now taking a significantly more active role in companies to allow for that conversation to take place and to have a much deeper partnership with the business leaders to be more intentional about development. And I would say what I see is that's the best practice where they partner together and say, "My needs are like this," right? "These are some of my needs on my team, and here's our solutions. And how do we bring these solutions more systematically to all levels so that we can uplevel everybody?" And companies that do do that and have these conversations, then they, they're more disciplined as well as more prioritized around that topic. And where it doesn't become that partnership conversation on the table, it's harder, certainly harder. And I'm being completely frank and candid on that. [00:17:28] Lindsey Dinneen: Yeah. Yeah, I appreciate that. Yeah. Okay, so one of the things I noticed on LinkedIn is --you have w- several wonderful things. One of them that I really enjoyed was kind of seeing your different book recommendations, so it seems like you are a very avid reader, and also you grew up in a very musical environment, yeah? That's part of your background. So I'd love if you share a little bit about those, and maybe how you think that has helped you as a leader in your career. Just h-how do those things interplay? [00:18:02] Anastasia Mironova: Oh, you, you, you run a risk of getting me into my soapbox a little bit, but mus- yeah, yeah. Music is big. So I, I went to music school for 10 years and learned to, to play piano. But I probably could write a book about the parallels between music and leadership just for fun of it at someday when I retire and have time, because learning music really taught me a lot about leadership in, in a number of ways. If you think about medtech and you think about, again, how much of it is very cross-functional, a lot of different groups have to come together, words like alignment come to mind, right, all the time. In music, it's interesting because you have to listen to yourself as you play to make sure that you self-correct. And so that listening, that ability to listen to "How am I coming off right now?" is, is really important, I think, in leadership, particularly today when everything is more about being more inclusive, right, being more diverse in how you build your team. So I would say that listening ability is huge and shaped me as a leader. And the other one is the power of pause. If you, if you don't pause when you play when you're supposed to, it's just not gonna sound the same. It's not gonna land the same. And so, like that power of pausing to allow for a better response is another huge parallel, particularly in executive levels and like how you show up. And I would say probably the other one is ability to prep. There is a lot of preparation in leadership. You can attest to that. There's a lot of prep that goes into it. But then there comes the time when you have to go and in high stakes be composed and, and read the room and, and, and get there. So lots of parallels. I could think of many more, but these are just like the top three that I would say definitely prepared me, again, when it matters, you know? 'Cause I, I think a lot of times in leadership we talk about, you know, culture and engagement, right? And trust, and those are fundamentally unbelievably important. But I oftentimes think that leadership falls apart in those high-pressure moments, right? And music prepared me to deal with that quite a bit, so. [00:20:23] Lindsey Dinneen: Yeah. Oh, I love that. So I t- I talk about this quite a bit too with s- my background is also in the arts, but on the dance side. I'm a professional ballerina, and, and one of the things that I often talk about is how, yeah, it prepares you for really high-stakes environments where you're gonna go in, and honestly, it doesn't really matter what kind of day you've had, what you, what's going on in your life. You're there to perform, so you have to learn to show up poised and in command and with confidence that may or may not actually exist. [00:20:56] Anastasia Mironova: Yes, definitely. Definitely. Yeah. Yeah, you have to compartmentalize it all. And even if you make a mistake, which is inevitably that does happen on stage when people are watching and all eyes are on you, and there, lo and behold, you tripped on a note or it didn't land quite there, and you just have to keep going. And I think that that skill is tremendous in leadership. [00:21:25] Lindsey Dinneen: Yeah, could not agree more. Okay, so you mentioned when you were first telling us a little bit about your story that there was a moment that kind of really made you fall in love with the industry or, or helped you feel fairly passionate about it, and I was just wondering, I always love learning what, what is a moment or a couple of moments that stand out to you as just affirming, "Wow, I am in the right place at the right time"? [00:21:50] Anastasia Mironova: Yeah, it's, it's a little bit of an emotional story, but I started my career in medtech in a external defibrillation category, which in simple terms, at the time, it wasn't something that was mandatory in schools, stadiums, airports, planes, you know, all these things were now are equipped with a little portable defibrillator wasn't the case. The laws haven't yet been passed, and so we were pretty early days, and we had to fight oftentimes very hard to get one of these into, say, schools. And so one of our team mem- members on the sales side did that, and later on, I met a six-year-old boy with his mom who survived sudden cardiac arrest in the school that we were able to fight and place the AED in because he collapsed with sudden cardiac arrest. And so we, we brought him to, to our company, and this little human was on stage, you know, alive because so many people carried that part, right? And I just get emotional just talking about it. That was my moment. It was really early on, and I literally just committed to it and never looked back. And I'm so happy that he was there , and then we met many more, you know, throughout the years, but that was my pivotal moment for sure. [00:23:10] Lindsey Dinneen: Oh, that's such a beautiful story. Thank you for sharing that. I, yeah, that, yeah. I can see why that would get you every time because what an amazing, what an amazing thing to get to... 'Cause, you know, you, you know you're in a good industry doing good things, but when you get to see the impact on a patient, and a little human and to top it all off, oh my gosh, that's, that's beautiful. Yeah. [00:23:34] Anastasia Mironova: Thank you. Kids, right? And, and, and I've met a few patients since then that have been positively impacted, adults, various ages. And again, it just-- it's such a reminder every time. Even when I now work with my clients and I, you know, would talk to them about whatever their challenges are and work through that, most all of them share that and tell me, " Yesterday I was reminded, you know, because I met-- I went to the hospital, and I met, you know, some, some patients." It's unbelievable. Purpose. [00:24:05] Lindsey Dinneen: Yeah, exactly. Yeah. Yeah, yeah, absolutely. Well, okay, pivoting the conversation a little bit just for fun, and based on a previous answer, now I'm, I'm wondering if this will be similar, but imagine that you were to be offered a million dollars to teach a master class on anything you want. Could be within your industry, it doesn't have to be. What would you choose to teach? [00:24:28] Anastasia Mironova: I would choose, I would choose to teach two things. One would be how to not fall apart under pressure, for sure. I would teach that in a heartbeat because I feel like there's just so much to it, and it's fun. It's actually fun. It's very, very learnable, and contrary to people's belief, anybody can learn that. So I would totally teach that. And I would teach it, believe it or not, how to tailor your message. The marketeer in me is still very much alive. I would teach about you can take this one thing that you really need to deliver and deliver it 16 different ways, and this is the one or two ways that it's going to get it landed, whether it's your investor pitch, your initiatives, your budget, your people, whatever you need. There's so much power in that, in tailoring it to the audience, and I have fun doing that, so I would probably teach those two things. [00:25:27] Lindsey Dinneen: I love that. That's awesome. Okay, and then how do you wish to be remembered after you leave this world? [00:25:33] Anastasia Mironova: That's a weighty question. Probably in two ways. For me, my most important values are my family, if you haven't guessed that already. So I would want to be remembered that I've spent a lot of really good special moments with my daughter and with my family because I feel like that's, that's what matters at the end of the day. And I would like for all the people whose lives I touch today and throughout my career leave with feeling more clarity, lighter, and just more uplifted after talking to me, and so that I leave them better off than when we started because that's, that's the legacy I want to create. I do believe both leadership as well as our personal life are comprised of those hundreds of very small moments, and that's how I would like to be remembered probably. [00:26:26] Lindsey Dinneen: Yes, I, I love that. I-- that's a beautiful legacy, yeah. All right, and then final question: What is one thing that makes you smile every time you see or think about it? [00:26:40] Anastasia Mironova: My daughter's paintings, hands down. So I have a, an artist in the house, which I, I'm not artistically inclined from, from, from a painting perspective. Music, right, not painting. And she paints a lot, and so every time I see something being created, whether it's silly or serious, whatever she- her, her mood is at, it just makes me smile. So it's my, it's my instant instant smile of the day. [00:27:04] Lindsey Dinneen: Oh, I love that. Yes, I, I love art in general, and very much share the same, you know, idea that there's so much that you can take from what you learn from the discipline of, of being in the arts to where you go in the future. But anyway, that's so much fun to hear, so thank you for sharing. And just in general, thank you so much for being here today. I really appreciate it. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. I, I loved hearing your stories and your advice, and I appreciate how you're helping the next generation of leaders to succeed. This is such an important industry, and we want people to be successful, so thank you for the work you're doing to change lives for a better world. [00:28:05] Anastasia Mironova: Oh, thank you, Linds. Thank you for having me. I am really honored. You bring such wonderful guests always, that I look forward to your next episodes as well. Thank you very much for having me. I had so much fun talking to you. [00:28:16] Lindsey Dinneen: Awesome. Good. Well, thank you, and until next time. [00:28:20] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Brent Lavin, principal at Ironwood Medtech Partners, shares how he helps early-stage medtech companies build commercial strategies from concept through commercialization and exit. Brent reflects on his path from electrical engineer to launch expert, including lessons learned after seeing how overbuilt product features can complicate V&V and FDA review, and why founders must make early decisions with the end in mind. He discusses common startup pitfalls, the importance of pairing technical innovation with a strong commercial plan, and practical leadership insights on hiring “the right seat,” delegation, and setting clear standards while allowing teams flexibility in execution.    Guest links: https://www.linkedin.com/in/brent-lavin/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 084 - Brent Lavin [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest Brent Lavin. Brent is currently principal at Ironwood Medtech Partners, where they help build the commercial logic into medtech startup innovation from concept through commercialization and exit. As an engineer turned launch expert, Brent has helped commercialize 20+ 510K PMA products and led the buy side of four M&A transactions, so he knows what buyers value beyond the science. With a diverse background from GE Healthcare to C.R. Bard to BD to now leading Ironwood Medtech Partners, he thrives on helping early-stage companies navigate the complex healthcare landscape and build successful companies. All right. Brent, welcome to the show. So glad to have you here today. [00:01:39] Brent Lavin: Yeah, great to be here. Thanks so much for the invite. I appreciate it. [00:01:42] Lindsey Dinneen: Absolutely. Well, I'd love if you would start by just sharing a little bit about yourself, your background, and what led you to medtech? [00:01:50] Brent Lavin: Yeah. So, I'm Brent Lavin. I live here in Phoenix, Arizona. I've recently founded Ironwood Medtech Partners, which is my company helping early-stage medtech. But I spent nearly 20 years in strategic medtech, and so I originally came to the industry through the engineering function. I was an electrical engineer in product development and innovation. And after three or four years of that, decided I wanna move over into what was, what is traditionally product management. And so, through my MBA program and then starting with GE Healthcare, I've spent the last 20 years at this intersection of R&D innovation, strategy, business development, and marketing. And so, really great run. Have been on the buy side of several M&A transactions, and I try to bring all of that experience to the early stage so that, you know, companies as they start out, can be building for the future. And so, it's been a great journey in medtech, and I've loved it so far. [00:02:46] Lindsey Dinneen: Yeah. Okay, so, so many things to ask about, but I'll, I'll start here. So, all right, so you're sa- you know, as you, you mentioned building towards the future and especially with these young startups that might not have a lot of experience in that particular kind of environment, or they're leading their company for the first time. What are some of the things that you see that maybe are pitfalls to avoid? Just, just like maybe some of the things that you've seen startups struggle with a little bit, and how can we help them mitigate those risks? [00:03:17] Brent Lavin: Yeah, there is a lot there, but let me just start by saying there is no linear path, and it is a very circular, ongoing process as you work through those early stages. And we call it the fuzzy front end for a very good reason. And sometimes you need to go down paths to realize that's not the right path, and you need to be comfortable with that. But at the end of the day, one of my goals is to help early-stage companies build with the end in mind because whether you acknowledge it or not, you're making decisions today that are ultimately gonna affect how you commercialize in the future. And so at least being able to make those decisions with your eyes wide open and understanding the trade-offs that are going on. And so for somebody that's been at the very end of that process, I, I can help inform, you know, those early stages so that you make priority decisions and trade-offs, you know, with full-scale information. [00:04:17] Lindsey Dinneen: Okay. Yeah. Well, I, I love the fact that you highlighted it's not a linear path, and there are a lot of things that go into, of course, the success of a startup. I'm wondering, in, in your role now, what are some of the areas which you see successful startups really thrive in as they're working with, with somebody like you to help make them successful from the start? [00:04:42] Brent Lavin: Yeah. Thanks for that question. I love working with early-stage founders that are passionate about their technology but especially those that realize where they may need to supplement their technical background with more of a commercial mindset. And so the, the people that work, that I work best with, are open to inputs and consideration of other options as they go through that process because you know, the, the famous saying, "What got you here is not what's going to get you there." And so while technical innovation is, is key that may not lead to an acquisition if you can't tie it to a strong commercial plan. [00:05:22] Lindsey Dinneen: Mm, mm-hmm. Yeah, so actually this is an area that I'm very curious about even in your own journey is, so you started off with that technical background as an electrical engineer, and I'd love to hear a little bit more about that as well. But maybe if you don't mind sharing a little bit about the transition or the learning process of going from that as a really good base to also being able to understand the full life cycle and how to make something succeed. [00:05:47] Brent Lavin: Yeah. Well, let me kind of go back to those engineering days and talk a little bit about how I made that pivot from engineering into product management. And to be honest, I didn't know exactly what I was doing at the time, but a-as an engineer, I was working with a product development team where we were creating a project. I was at a s- a contract design manufacturing company, and we were working with an outside company that owned a patent for a laboratory blood culturing instrument. And so we were their engineering partner, and what I saw firsthand was unfortunately, this customer at the time did not have full insight into the workflow and how the device was used in practice. And so as an engineering team, we frankly overbuilt many options into the product in order to try to s-satisfy everybody. And that seemed attractive at the time, but ultimately when we got to V&V, verification validation, and the FDA review process, it was a real struggle to get this on market. Now we ultimately did, but the epiphany for me was, I am really good at understanding engineering trade-offs and working with engineering teams to go through the process of evaluating different options. But I also really like working with customers and understanding what moves the needle and what's the difference between a nice to have and a need to have. And so, it was that kind of experience firsthand that led me to say, "I wanna operate at this intersection and really operate in both sides of that equation." And so ultimately I decided I needed to get an MBA in order to do that. So I left a, a good paying engineering job right after I got married and we moved to Madison and I got my MBA and then, you know, that ultimately led to GE Healthcare and, and then, you know, continued career in medtech. So thanks for asking that question. [00:07:43] Lindsey Dinneen: Yeah. Well, okay, so your leadership journey, of course, has, has evolved over time as, as often happens, and, and you've gone from leadership positions within other organizations to, of course, now leading your own. And I'd love if you'd just share a little bit about that journey of, of growth and discovery, maybe some, you know, lessons learned along the way. [00:08:06] Brent Lavin: Yeah. So, let's talk a little bit about kind of my formal leadership in the, you know, corporate structure and organization. I would say, we were chatting beforehand that, you know, I really moved through slowly at the beginning of my leadership from one person to three people to five people. And as an ambitious person, I always felt like that was too slow. And so, but I think it was those foundational aspects of working very closely one-on-one with people, hiring, deciding who to hire, selection, onboarding having crucial conversations about performance management and how to put people in the right seat to be successful, all occurred when my leadership span was frankly smaller than probably I was hoping it would be. But at the proper time, my leadership expanded very quickly from five to seven and ultimately 22 people within about an 18-month period. And if I had not had those slow steps along the way, I don't think I would've been ready for that and I, I would've struggled. And so, even though my ambition was high, the pace was just right in order to be successful in that. Now, to your second part of the question of, you know, how do you then transition to this, this new role? That has been a learning experience, and I'm not sure I have it mastered but it is all about influence. And so, you know, leadership, even in a formal organization, while you can be connected on the org chart, ultimately boils down to influence. And so my goal is to influence early-stage companies to understand the trade-offs that they're making and hopefully help them chart the best path forward for the goal that they have, you know, individually. Every company is built differently, and so I try to channel what their goals are into my recommendations. [00:10:02] Lindsey Dinneen: Absolutely. So you mentioned something that is brought up often, but I think it's a concept that would be worth diving into, and that's the concept of the right seat, and I would love if you would share a little bit more about your philosophy behind that and how, as a leader too, if you know that there's perhaps somebody who's a great fit for your organization but isn't in the right seat, how do you help make that happen? [00:10:29] Brent Lavin: Yeah. So this is back to the seminal Jim Collins book. You know, get the right people on the, on the bus and then get them in the right seat, correct? And so I always tried to select the person first and then find the opportunity. And there are times where you need to pivot people. So let me tell a, a quick anecdote about, you know, a situation where we had somebody on my team, and this person had progressed through different product management roles, but this person also had a project management background and was really passionate about project management and brought those skill sets to product management. But they are different, and that... Her passion was in project management, and so I knew of some upcoming and different opportunities in the organization that would be very project management focused and that, that position was not even on the org chart at the time. But as I had discussions and, and understood that that was becoming a reality, then I turned and, and offered that to the, to the person and ultimately they, they took that new opportunity. And so, it's really understanding really their long-term goals as well as, you know, their strengths, their natural strengths. Not just where they're operating, but what their natural strengths are, and then sometimes even creating an opportunity for them. [00:11:51] Lindsey Dinneen: Mm-hmm. Yeah. Yeah, and so, okay, so, so you've had kind of, a really cool opportunity to get a really good look into some of these startup companies who, you know, their founders might not be in a place where they're able to necessarily hire a whole bunch of people right away. How can you come in and support them when they're, say, like really young, maybe pre-seed, trying to figure out what the next right step is and, and able to sort of help lead them also in that transition of, you know, perhaps single founder to also a leader of a company? [00:12:32] Brent Lavin: Yeah. That's a great question, and I'm early in that journey, right? And so, maybe not some specific examples around that, but certainly again, you know, leadership is influence. And you know, I try to understand as a leader of people in a, an organization what everybody's goals are, personal and professional goals are, and then match, you know, again, what I can do to, to their, to their interests. And so when you talk about, you know, early stage CEOs, sometimes it's just a matter of listening as an unbiased outside observer who has no money in the company. And so, it can just be providing perspective from years of experience and asking insightful questions, you know, even before there's a relationship, a business relationship, between, you know, my company and theirs. And the goal is to help everybody be successful. Like, I'm a passionate medtech leader that wants, you know, th- these innovations to reach market. And so, people have lifted me up along the way, and if, if I can do that just in, in conversations and mentorship, certainly willing to do that and have done that. But as, you know, a CEO transitions then into seed and Series A, just providing, you know, again, leadership perspective from, you know, my corporate experience can be helpful. Because ultimately people are not gonna do things exactly the same way that you've done them as an individual contributor, and you have to become comfortable with allowing people, giving people the, the guardrails, and then allowing them to operate in their own style to achieve the results that you've laid out for them. [00:14:20] Lindsey Dinneen: Hmm. So yeah, and th-that's been something that's been talked about quite a bit is that art of delegating, and how do you give your people the right guardrails without making it so narrow that it feels like you're kind of micromanaging, but you ha- you have to maintain culture and brand, you know, like tone in the way that you speak. So, what are some strategies or tips that you might have for, for a leader who is in the position, needs to delegate? This is maybe a first time. It's a little bit hard to let go of the baby, as it were. So, so how do you help them navigate that? [00:14:55] Brent Lavin: Ye- yeah, I, I would go back to my own experience where, you know, I probably didn't do this the best the very first time that I had people on my team and was delegating. And I would say that most high achievers struggle with delegation for the first time because people are going to do things in a different way than you did. And I tried to teach my way, but as I grew and expanded and got, you know, mentorship and, and learned through that process, I started to go f- you know, higher o- on the ladder to, you know, values and culture and expectations, to your, to your point before. So, as a leader you have to be consistent and just unending in your communication of expectations, values, and standards, and then hold people to those. And so I, I say this often. I live in South Chandler, Arizona, and Scottsdale is maybe 40 minutes away. You know, a new leader would say you know, "You gotta go up the 101, you need to take Exit this and that to get to the coffee shop." Where as I grew more comfortable and confident, I would say, "We're gonna meet at this coffee shop in Chandler." And if they wanted to take surface streets and hit all the stoplights, so be it. And so you gotta become comfortable with that. But at the same time, our standard is "We're gonna meet at this coffee shop at 11 o'clock sharp, and I expect you to be there." [00:16:26] Lindsey Dinneen: That's a great analogy. I love the way you put that. Thanks for sharing it. Yeah, that's-- and that's a really interesting way of thinking about it, is there's, there's many avenues to getting something done correctly and to meet those expectations that you set forth, but there can also be room for creativity on how that's done, how that's accomplished. [00:16:46] Brent Lavin: Yeah. You know, one of the team values that, that I had with my most recent team was around this idea of, of play to win. And you know, over time, I actually adjusted that with some feedback and some further, you know, kinda study on leadership toward striving for excellence. And so I think the play to win was a little bit narrow in that you can't always control everything around you. And winning is an outcome that may be dependent on some other factors that, that you can't influence. And so that was a little bit narrow and, and too outcome-focused. But strive- striving for excellence was something that we could talk about daily, and you may not win, but as long as you strive for excellence in whatever we're asking you to do, like that's the standard. And so, that became a lot more robust, I would say, in the conversations that we had around setting and ensuring expectations. [00:17:45] Lindsey Dinneen: Yes, I love that. Excellence over perfection, especially for those of us who are what I would fondly refer to as a recovering perfectionist. So. [00:17:53] Brent Lavin: Mm-hmm [00:17:54] Lindsey Dinneen: I love that. [00:17:56] Brent Lavin: Yeah, it's a present tense recovering, right? Because we're never fully recovered. But... [00:18:01] Lindsey Dinneen: That's right. That's right. Absolutely. No, I love that. So just out of pure curiosity, when you were, say, I don't know, seven, eight years old, could you have possibly imagined becoming an engineer and/or doing what you do now, which is so much even more robust? [00:18:18] Brent Lavin: Oh my gosh, Lindsey, I love this question, because I couldn't, you know? I didn't. I grew up in small town USA and you know, I, I was really focused on it, you know, being the best at any single sport I could play. I, I was just a ball kid and, and but I loved entrepreneurship. And it's funny you say this because I think in high school, you know, they have those like, "What are you gonna do when you grow up?" I wanted to own a sports bar. And yeah, so like I wanted to help serve good food and, and just have a lot of TVs around and and be an entertainment spot. But I just kind of had that entrepreneurial, you know, itch. And so I, I pretty well knew I was gonna be an engineer just because I was good at technical things, and I loved it. Like, it wasn't work to me. But I didn't even understand what medtech was. And I was 22 years old in my first engineering job. I was six months into the job, and I ended up in the ER on the weekend, and excruciating abdominal pain. And they ran a CT scan, and they found the problem, they relieved the symptoms, they sent me home, and they said, "You need to see the surgeon on Monday morning." Not really understanding what was going on, but I distinctly remember being in that surgeon's office the next week and seeing the axial image of the CT scan on the light box, like the physical light box back then. And I was fascinated. I was fascinated that they chopped my body like a loaf of bread, and within about 30 seconds they could identify the issue. And you know, the surgeon said, "Y- you have this recurrent diaphragmatic hernia, and you're gonna be in surgery in two days." And so I was not scared. I was more fascinated than anything, and that is what crystallized, you know, my need to get into, to medtech. I didn't even know it existed, but I said, "I wanna go do that." And if you fast-forward about five years, there I was working for GE Healthcare, you know, the maker of those CT scanners. And so, I think medtech is really hard. It is not the most glamorous industry. So we all need that why, and for me, again, that Monday morning in the surgeon's office is my why. [00:20:31] Lindsey Dinneen: Hmm. I love that. Yeah, and I love that that's your why, and sort of a follow-up question to that then is, are there any moments that stand out to you along your journey being in medtech that particularly reinforced to you, since making that decision, say, that you are in the right place at the right time? [00:20:52] Brent Lavin: Yeah, and, and I don't mind talking about this. I'll tell this other story. About 12 or 13 years ago, I ended up learning that I had an autoimmune condition, and if you fast-forward, I, I was on some pharmaceuticals, and I've recovered, and I'm all back to normal, but I still live with that. But you go to today, and there are neuromodulation solutions that are addressing autoimmune conditions. And so we're now giving patients a choice between a device-based intervention and a pharmaceutical intervention or a pharmaceutical treatment. And I did not love those pharmaceuticals. They, they had certain side effects and I didn't wanna be on them the rest of my life. Now, I've weaned off of most of them, but patients today are getting an option for a device-based intervention, and so that's what medtech is about. And so when I hear stories of like th- like this, I'm like, "I'm exactly in the right place." And so, there's so much opportunity for us to innovate and impact pa- impact patient lives whether that's ourselves, you know, our family members, or people we may never meet. [00:22:03] Lindsey Dinneen: Yeah. Yeah, thank you for sharing that story. That's-- it's incredible to see. I think one of the best parts about being in the industry is getting to feel hope on a daily basis, yeah? 'Cause there's always something new coming out. These, like you said, medtech is really hard. There are a lot of really tough days, sometimes very not glamorous, and you just... if you have that why, that helps pull you through those days. But I really love what you touched on there of how those innovations that are coming through, that is reason for hope and just optimism again, especially in a, in a world that needs that really badly. [00:22:45] Brent Lavin: Yeah, I think it's easy to be cynical about healthcare. But I guess I choose hope. And yes, we have some structural things that we need to work through. Yes, we have a reimbursement climate or regulatory structure. But to me, that's just a great puzzle, and the, the innovations that do have an impact, not only on healthcare patients, but also economics, are the ones that are gonna win. And so I don't mind that it's a high bar, you know? And so, that just means that we need to all be a little bit better, 1% better, and continue to make a difference. [00:23:20] Lindsey Dinneen: Yeah. No, that's, that's so great. I really love that. Okay, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach? [00:23:41] Brent Lavin: Yeah. I love that you asked this question, and I could go a lot of different directions. I, I think I'm gonna say, you know, I would love to teach the process of structured customer insights. And so I'm thinking back to the whiteboard of an early stage and then throughout the con- the, the journey of a company. But I think there's a big gap between asking questions to learn and asking the best questions that can ultimately influence your business decision. And so it's not only what you're asking, it's how you're asking it, why you're asking it, and then doing the proper follow-up during the conversation in order to learn the true insight. And so I love baking and I love barbecue, maybe back to my, you know, sports bar dreams. But I think there's a big difference between following the recipe of a baking, you know, process, and doing barbecue, which is very process-oriented and no two things are the same. And so I think we need to approach customer insights a little bit more like barbecue, where you definitely have a goal and a process, but you're willing to adjust and make the changes as you learn in order to affect, you know, the business decisions. [00:25:06] Lindsey Dinneen: Hmm. Yeah. Okay. I really like that. I also like the illustration of the barbecue analogy. That's, that's fun. So okay, so I do have to ask a follow-up question then. So how did this skill set come about for you? Is this something that you, you learned, say, during observations? Or how did you develop this, this masterclass, shall we say? [00:25:28] Brent Lavin: Yeah. I, I think it's, some of it's through my own kind of learning in having conducted just hundreds of physician interviews. And I think, again, early in my career, I used to go through a questionnaire step by step and, and I'd get to the end and I'd have a report, but I may not have the insight. And I think as, again, as I became more comfortable with that process, I would, I would take U-turns or I would take the fork in the road, depending on where the physician was going, and continue to learn maybe not something that was on my roadmap, but something I still needed to learn. And then as I became in- came into leadership, I, I think I just saw it again with early product managers that wanted to follow a recipe and wanted to check a box toward customer insights rather than, again, truly getting in the customer's shoes. I think one of the most fun things of my job in upstream and innovation marketing is when I can interview enough physicians about a particular narrow procedure or product concept, if I can interview enough of them, s- typically between 20 and 30, depending on how complex, and I can start to think like them. And that's the ultimate of a product manager, is to think like the physician. Again, it all depends on how complex the procedure is and whatnot, and we should always be striving to learn. But when you can achieve this secondary kinda personality that mirrors what you've heard from all of these conversations, there's nothing better. [00:27:10] Lindsey Dinneen: Really cool. Okay, excellent. Thank you All right. And then how do you wish to be remembered after you leave this world? [00:27:19] Brent Lavin: Wow. I haven't thought about this in a while. I think, how do I wanna be remembered? Obviously, you know, for my family by, like, leaving, you know, a good family legacy, and also just, I showed up. I just put my shoulder down, did the best I could, certainly wasn't perfect. But I tried to just do the best with what God gave me, and it happens to be in the medtech world right now. And I think I'm uniquely gifted for where I'm at. But I still wanna make more impact over, you know, the next couple of decades. [00:27:55] Lindsey Dinneen: Mm, mm-hmm. Yeah, absolutely. Okay, and then final question. What is one thing that makes you smile every time you see or think about it? [00:28:06] Brent Lavin: Yeah, I, I guess I gotta just go back to my family right now. I got four teenagers, you know, and we're just in an awesome period of life, and I was traveling last week, and just being able to come home, you know, see my wife, see the kids, can't help but smile. So, you know, my two boys are twins, are graduating high school, and those days are, are kinda short, so I'm just trying to soak up every minute of that right now. [00:28:30] Lindsey Dinneen: That's wonderful. I love that. Well, this has been a really great conversation, Brent. Thank you so much for joining me today. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. I'm grateful for you and for your impact on the industry. [00:29:07] Brent Lavin: Well, thanks for this conversation. I've really enjoyed it, and I, I can't wait to continue to stay in touch. [00:29:11] Lindsey Dinneen: Absolutely. Thank you so much. [00:29:14] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Allison Komiyama, a consultant and senior regulatory strategist at DuVal & Associates and founder of Bluestocking Health, shares her journey from neuroscience and an FDA reviewer role into regulatory affairs and consulting. Allison explains why companies should educate FDA about their device by telling a compelling, respectful story, and discusses why “getting through FDA” is often the starting line. She highlights the post-clearance work of launch, adoption, and promotion while staying within FDA marketing rules. Allison also reflects on leadership, relying on community and advisory boards, her volunteer work, and the moments that affirm her impact when devices reach patients.  Guest links: https://www.bluestocking.health/  Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 083 - Allison Komiyama [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Allison Komiyama. Allison is a consultant focused on getting medical devices to market and helping them stay there. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about the regulatory submissions as a faculty member at SDSU Global Campus. She received her doctorate in neuroscience in 2009, was an FDA reviewer from 2010 to 2011, received her Regulatory Affairs Certification US in 2014, and became a RAPS Fellow in 2024. Throughout her career, she's been actively involved in hundreds of pre-submissions and pre-market submissions for a wide variety of medical device companies. She recently started a medical device hype company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market. She's also a senior regulatory strategist at DuVal & Associates, where she helps companies navigate the FDA pre-market process. Alright, well, welcome to the show. I'm so glad you're here today. [00:01:59] Allison Komiyama: Thank you so much. I'm so glad to be here. [00:02:02] Lindsey Dinneen: Well, I've been looking forward to this conversation very much. I got to meet you, I think it was maybe last fall, and it was after watching a video where I believe you were chopping wood while explaining a medtech concept, I and was like, "I have to meet this person." [00:02:21] Allison Komiyama: I like that that is how we, we, yeah, that you were introduced to me is through a wood chopping video. But yes, that was me. I love... I am a lumberjill, so yeah. [00:02:31] Lindsey Dinneen: See? And we will get into this, let's start with just a little intro into who you are, your background, and what led you to medtech. [00:02:39] Allison Komiyama: Sure. So background's actually biology, neuroscience. Left academia after graduate school and went and worked at FDA. I was just there for a brief period of time, but it was very instrumental in having me understand what I wanted to do with my life. I knew I loved regulatory affairs. I knew that I loved med devices and the intersection of medtech and innovation and regulatory and, and, and, and, and, right? Like, so all the things I was just super excited to be part of this space. But after leaving FDA, sort of tried to figure out what... You know, did I wanna work at a company? Did I actually wanna be at a specific industry job? Tried that on. Tried that hat on for a little over a year at an IVD company and just sort of missed all the stuff I got to work on at FDA. So I kind of saw it as the second-best thing after FDA is to go into consulting. So really worked with a lot of startups and companies that were bringing their technologies to market, and yeah, never looked back. I did sort of change positions over the years from going from a small consulting company to my own consulting company to a large consulting company, and now I'm sort of back at a, a smaller regulatory law firm. It's not that small, but, you know, 15-some people at DuVal & Associates working with companies that need help with strategy and regulatory support as well. And also started my passion project, which is Bluestocking Health. It is a medtech hype company, is what I call us. And we really work on helping companies after they've made it through FDA onto what... you know, what does, what does their launch look like? How do they get people to adopt their technologies and not sort of flounder and, and fail, right? So I, I love seeing really cool, nerdy, geeky tech get to market, and I think we all have a sort of inner geek that loves stuff like that, and it's my happy place where I can just kind of talk about those things and share it with patients and caregivers alike. [00:04:47] Lindsey Dinneen: Amazing. I love that. Yeah, and so much to dive into. But one of the things also I remember, so so I, I watch this video and you're chopping wood, and you're, you're clearly super passionate about medtech. And then I think the next one, were you possibly like baking or doing some sort of maybe chopping? [00:05:08] Allison Komiyama: Yes. I do flower arranging, so it might've been that one. I, I-- That's a great idea, though. I love to bake. I love protocol, so I think you're onto something. I need to come up with a video maybe where I'm talking about, like, the de novo process and, like, baking a cake or something. So. [00:05:27] Lindsey Dinneen: Amazing. And you're right, it was flower arranging, and I was thinking at the time, "Is there anything you don't do?" [00:05:35] Allison Komiyama: Yes. I-- There's a lot of things I don't do or don't even dare to do. Mostly dangerous sports. I, I'm a rower, so I love to row where no one's touching you. You know, like no one... There's no physical contact. You're just in a boat pulling an oar, and it's quiet and peaceful and, you know, also you're working hard. So, but otherwise, yeah, don't want any contact sports in my life. And but there's a lot of things I don't do, of course. I just have a lot of hobbies and things that I enjoy doing. [00:06:10] Lindsey Dinneen: Okay. So did the idea for Bluestocking Health come from? I mean, I know you explained a little bit about what the company does and who it helps, but first of all, I'm really curious about the name, and second of all, I'm just curious about, yeah, what made you go, "Gosh, this is the right time for this"? [00:06:27] Allison Komiyama: Yeah, great question. I-- So Bluestockings were... I'll, I'll go first into the origin story 'cause I think it kind of helps explain why I picked up that name. The Bluestockings were a group of mostly women in the 1700s in England who were, you know, kind of tired of sitting around playing card games and, you know, learning new dance routines-- not that there's anything wrong with that-- I love doing all of those things. But they decided they wanted to pursue some more intellectual and intellectually stimulating conversations with people. So they would invite women and men into their salons to have these conversations, and they would talk about botany and, yeah, science, art, literature, theater, all of the things that sort of sparked their interest. And they would say, you know, "Don't worry about wearing your black stockings," which were, like, the highly fashionable, expensive stockings of the day. They said, "Just come in your blue stockings. It's fine." You know, which were wool and, you know, cheaper. And I was like, oh, I love that idea of just people getting together, talking about stuff that they find interesting, and having it be like, "Come as you are. Wear your sweats," you know? "Don't worry about getting fancy." And that resonated with me. And so I thought, you know, what I want to build is something similar to what the Bluestockings had, but have it be more medtech or health-focused, and so hence Bluestocking Health was born. I, yeah, I really... A-as I said earlier, I saw a lot of companies feel like getting through FDA was the finish line, and I s- you know, I would tell them, like, "No, that's kind of the starting line with a lot of what you're going to now need to build." You know? It's-- I, I think historically FDA was seen as, like, the hardest thing to get through, which isn't always the case, right? The, the 510K program is historically very successful with getting devices cleared. You know, FDA does wanna work with you, and that was my narrative and my mantra always was like, you know, "How do you work with FDA to get through FDA?" And then once you're through FDA, what's next? And I wanted to have those honest conversations, you know, as these companies were considering the product development, their quality system, their regulatory, and, you know, even reimbursement is also part of that post-market conversation. And I wanted them to also think about, "How are you gonna get patients to know about this? Like, what are ways that you can promote yourself and promote what you're doing without misbranding or mislabeling or adulterating anything, right?" You wanna stay within FDA's regulations and not do anything wrong marketing-wise. But it's also something to get really excited about, and I think we've often forgotten that a lot of these medtech devices do really, really cool things, do really amazing work to help people, help people s- you know, improve their quality of life. Let-- Help them survive, get them to live longer, let kids actually make it to adulthood, right? So there's so much good that I wanted to amplify that more. I wanted to get people to not just focus on the negative, right? There is, there is a lot of harm that can come from any sort of drug, device, anything, but there's also a lot of good. And so I think especially right now in the world we need more good things to talk about. Not that I wanna, you know, look at everything through rose-colored glasses. But I do think if we can focus on some of the good that's going on in the world and the things that we have in common, what a great conversation to have. [00:10:14] Lindsey Dinneen: Oh, yeah, I couldn't agree more. And I love the fact that and you're so much fun. You're helping these companies also get excited too, because I think sometimes it's really easy-- I mean, we need to take our industry seriously. It's a serious industry and real life consequences, good and bad, from innovation... [00:10:29] Allison Komiyama: Yes. [00:10:30] Lindsey Dinneen: ...But I think you know, we've, we've talked a lot about this recently, even ar- along amongst just some of my colleagues, is like we're gonna take, we're gonna take our actual work very seriously, of course, but we're gonna not take ourselves super seriously. We're gonna have fun. We're gonna celebrate. We're going to each other why we're here and why we're doing this, 'cause otherwise it can get easy to get kind of bogged down in the, the nitty-gritty. [00:10:52] Allison Komiyama: Oh, it's so easy to spiral. I-- And I feel like a lot of media allows us a-and, and capitalizes on that doom scroll/spiraling of, "Oh gosh, everything's bad." And I wanna be informed, but I also, as you said, I don't wanna take myself that seriously. Like, I have so many hobbies. I laugh a lot. I have really great conversations with people, and I think that's what I, you know... the legacy I wanna le- leave behind is that I made the world a little better than when I started here. And also that I had a lot of joy to share. So yeah. [00:11:31] Lindsey Dinneen: Okay. So I-I'm curious, going back to your days at the FDA, what are some of the common things that you saw where perhaps there's either a misconception about the process of approval or just mistakes you might have seen that were kind of common that maybe those who are listening who are trying to, you know, get through it as, as easily as possible could benefit from? [00:11:54] Allison Komiyama: I think one of the biggest misconceptions and it wasn't anyone's fault, was that FDA are the experts in what you're building. And maybe, maybe folks knew that that wasn't the case. You know, they walk in and they know that they're living and breathing their technology and their device day in and day out. They've been building it for years oftentimes. And so to think that FDA understands your patient population, understands the, the sensor technology or whatever technology you're building understands your software, your materials, all, all the various things that go into a s- a pre-market submission, is a terrible assumption to make, right? Not that you wanna treat FDA like a bunch of dummies, that you're like, "Oh, you guys don't know anything. I'm gonna have to start from, you know, square one here to really walk you through everything." But you definitely want to communicate and be able to tell a really solid story to FDA about what you're building or what you've built, and why you believe it's either safe and effective, or why you believe it's substantially equivalent, or why you believe the benefits outweigh the risks. And so I think if you can be that storyteller, if you can really walk FDA through what it is you've built, and why you think it should be, you know, allowed to enter interstate commerce, you've w- you know, you, you're already ahead of the game. So I think any company that really is trying to figure out what's that first interaction they're gonna have with FDA, whether it be at a pre-submission or just straight to pre-market submission, right? They're just gonna file the, the, the 510K or what have you. Really making sure that you've explained your product and they know why you're there. Otherwise, you are going to cause more questions than answers from FDA, and that's a big concern when you have somebody who doesn't understand what you're doing or why you've built it the way you've built it. That can really set you back. [00:13:56] Lindsey Dinneen: That's great advice. So, so being really prepared to kindly educate while telling the story, but you know, doing so, of course, in a, like you said, a respectful way. But, but having those answers ready, having the narrative really thought out so that you can walk in with that authority, but also explanation and storytelling. Yeah. Okay. [00:14:19] Allison Komiyama: Exactly. Yeah. It is. I mean, I always my-- I've actually, I have a podcast that I f- a few of my guests recently, they've all been expert or experts in how we tell stories, which I love even just... I mean, how we tell stories to our children is very different to how you tell a story to a colleague at work or, you know, the... and there's a way that, once you know your audience and once you know what it is you're trying to convey, there's a very clean path that you can follow. I'm still working on it. I have to, I have to confess, I am not a great storyteller. I have a tendency to get sidetracked and off topic, probably like what I'm doing right now. But, but you know, bringing it back and, like, what are, what are we trying to do? What are we trying to accomplish? And that I think that storytelling is really valuable when you have FDA as your audience. [00:15:15] Lindsey Dinneen: So I know, like you said, you have many hobbies and lots of things that keep you occupied, but you also do a lot of volunteering for boards. And I was wondering if you could share just a little bit about some of that experience and what you're passionate about there. [00:15:29] Allison Komiyama: Yeah. I think I've always been a big fan of volunteering. I think it's one of the ways that I I meet new people, I get involved in s- things that are outside medtech, which I think is extremely valuable. There's so many voices that even if it's not directly in medtech, everyone's impacted by medtech in some way, right? Like I always say, "You're either gonna start in a hospital or end in a hospital, and you're probably gonna go into a hospital at many different times or use a medical device, whether it be on your phone or, well, while you sleep or," you know, for any-- I don't know, there's a million purposes that people use medical devices. And I wanted to have more voices around me that that are, that are helping humanity, but in a different way. So, one of the boards that's always been near and dear to my heart, of course, my rowing club. I love... It's the oldest women's rowing club in the world. It's called Slack Rowing Club, based here in San Diego, and I help with a lot of the programs, but also fundraising, membership, and just, you know, having this really dynamic group of 400 women that some of them row, some of them are just there to be part of a community and help each other, which is pretty marvelous. And we do a lot of actually talks. Like we'll have a speaker series and we'll bring in physicians or we'll bring in people who are talking about sleep and perimenopause and menopause or, you know, various topics that definitely impact our our cohort. It, it's actually kind of similar to Bluestockings, like the original Bluestockings, where we'll have someone come in and talk about architecture. Like there's various things. So I love doing that. It's also-- They're-- The members are from like 12 years old to 102 years old. It's pretty amazing, and just, like, this great dynamic group of women who are fun to volunteer with and also sit in a boat with. The other one that I've joined last year was the International Relief Teams, which works on helping bring some sort of relief to an emergency situation, whether it be floods or fires or famine or war. Like, there's, They partner-- We partner with different organizations that are, like, boots on the ground in those areas to either build houses or get m- meals or get water to where it needs to be in an emergency. So IRT is fantastic. They get, like, one of the highest ratings of nonprofits. The other one is Indy Medtech. Really cool. That's a very medtech-based one. It's a virtual board, but it is building a community of medtech suppliers and people who are just needing support from each other or you know, either hiring or, "Hey, I have a question. Can someone help answer this 'cause I don't know where to go to get the answer to this?" So really cool, and they, they're doing a podcast as well. I love it. And then last but not least is the San Diego Regulatory Affairs Network. So I have been in San Diego, moved here back here, I should -- i'm from San Diego-- but moved back here in 2011, 2012, and I joined the San Diego Regulatory Affairs Network. It's the SoCal... Like, there's a similar one in Orange County, the Orange County Regulatory Affairs, so OCRA, and then there's also, of course, RAPS, and there's a Southern California chapter. And it's just a group of regulatory folks that love to meet up, love to support each other. "Hey, I have this job opening coming up. Hey is there a mentee that would like a mentor?" And so I'm now the VP of programs for that, and once a month we try to have a speaker either virtually or in person. There's gonna be some in-person ones. And I love it. It's just a great way to network, to support each other, and also to learn more cool stuff going on in regulatory. So yeah, that's a smattering of the ones that I'm part of. So, you know, as, as you said, like, it's kind of like they're all over the place, but it definitely makes me feel more connected with humans, with our-- you know, like, and, and not doomscroll. I'm, I'm too busy to doomscroll. So. [00:19:44] Lindsey Dinneen: That's, that's a good thing, I feel like. So, I love that. Okay. Those are g- those are such cool organizations. Thank you for sharing a bit about them. [00:19:51] Allison Komiyama: Yeah. Thanks for asking. [00:19:52] Lindsey Dinneen: Yeah. So all right, I'm curious. Going back, could eight-year-old Allison have ever imagined what you're doing now? [00:20:02] Allison Komiyama: Never in a million years. Yeah, I think I, I knew I loved biology and bugs and science at a very young age, so I knew that I was probably on that trajectory. But if you asked eight-year-old-- or actually, I-- if you asked five-year-old Alison what she wanted to be, the first was hummingbird, and I did... That did not pan out. [00:20:29] Lindsey Dinneen: Dang it. [00:20:29] Allison Komiyama: But and then I would say florist 'cause I love flower arranging, so that is something that I've s- I've kept up with, as you said, like you saw the video of me arranging flowers. I still love doing that. I, I enjoy that creative outlet. But not in regulatory. I didn't really know that regulatory affairs existed as a career especially until I was 26. I mean, which is crazy to think, like I was in grad school, and I took a course on the history of FDA, and I was like, "What is this? This is so exciting, so interesting." And I knew that was something, that something along those lines is what I wanted to do with using my biology and, and neuroscience background, but also how do I maybe get closer to medicine in a certain way? Like, I, I didn't wanna be a medical doctor, but I knew I wanted to help people. Like, I think most people wanna help people. And that was, that was the right pivot for me at that point. [00:21:32] Lindsey Dinneen: Amazing. So, all right. So you've had a bunch of different leadership positions now over the years. And of course, you have led your own company now a couple different iterations, I suppose, of, of what you've been doing. But what has that leadership journey been like for you, especially perhaps how different it is between working for another company where you might be in a leadership role versus leading yourself and your company? [00:21:56] Allison Komiyama: Great question. I-- what was it, what's it been like? I would say there's like equal parts fearlessness, excitement, and terror. I don't know, like I-- maybe those are all kind of, of the same like ilk of those, those feelings. My daughter always says, she's like, "I'm nervous and I'm excited," like before she goes on stage in the talent show, and she's like, "I'm nerve-cited." And I, I, I use that a lot now too 'cause, you know, before I give a talk or before I you know, go on a podcast like this, I'm like, "I'm nerve-cited," 'cause it's gonna be something that I haven't done before, right? Every day is a little different and... But it's also exciting to do. I Yeah. I, I feel like it was not always easy. Like, people are like, "Oh, you made it look so easy and, and just, you know, seamless." And oof, there were moments that I really struggled. It's... You know, there have been times that I really relied on my family, on therapy, on my friends to really help me. And even just, you know, something as simple as I had a friend who made my first website for me. He was like, "You're so busy and stressed," like, "Let me help you." And so I think calling on others and really having people be your community that you've built, right? Like, I think sometimes we try and go it alone, and maybe that's the worst thing to do when you're building something 'cause you really need to rely on others to help you out. And so I've had, you know, I've, I've, I've worked really hard on my network and to build the friends and colleagues that I want to surround myself with, and then I have reached out to them when I knew I need them. So I, for example, I think with Bluestocking Health, I... When I was-- Before I launched in last year, so September of 2025, I called a bunch of folks that I really trusted to tell me if I was going off course or to also help me build stuff. And my advisory board for Bluestocking Health is amazing. Like, they're not all in regulatory, 'cause that's not what I wanted to build. They're in media. They're in quality system, reimbursement, business strategy. Like, there's such a diverse group of folks that will also help be my sounding board, right? Like, I had a couple medical doctors that I reached out to that are on the advisory board that I was like, "I'm thinking of doing this. Can you give me, like, your thoughts pro/con?" And they always are so willing to help, right, if they have the time. It's been extremely rewarding. So I would say that leadership journey, again, not the easiest at times, but also when it gets hard calling on those friends to really support me has been really marvelous. [00:24:49] Lindsey Dinneen: Yeah. You know, that's such an interesting thing because this has come up a lot, especially in the last few episodes and just conversations I've had in the industry of the importance of community and mentorship and surrounding yourself with those good people who you can call and go, "Okay, I have this, I have this, I think maybe crazy idea. What do you think?" Or just, "Hey, life is a little tough right now. Can we just, can we just talk?" So that's... [00:25:15] Allison Komiyama: Yeah. [00:25:15] Lindsey Dinneen: ...Really cool. [00:25:17] Allison Komiyama: Yeah. Absolutely [00:25:19] Lindsey Dinneen: Yeah. Okay. So as you've gone through your career, and especially within the medtech industry, which seems like you've really just, you know, fell in love with and, and stayed, so that's wonderful. Are there any moments that stand out to you as really affirming that, "Yes, I am in the right place at the right time"? [00:25:40] Allison Komiyama: I think every clearance De Novo granting that I've ever been part of, even if my name's not on the file, has been one of those moments where, oh, it feels so good. It feels so great to see those companies make it through FDA. And then also, you know, to the next point or d- you know once they are selling and they're, they're helping patients, I've had clients reach out to me and say, "I just got this amazing testimonial from somebody and I wanted to share it with you because you were part of that journey." And oftentimes I'll say, "Can I share that with the FDA reviewer that helped us 'cause they're still there and I really think that they would value that, that piece of information, just that commentary and that validation." I mean, w- I've had ones where the testimonial was like, "Because of this device, my kid is alive today. My kid would have been-- would have died two years ago if it hadn't been for this product." And like, I even just got chills. Like I-- honestly, it feels like even though I'm not a medical doctor, even though I was, you know, integral maybe in putting their 510K together or their submission together, and I've never touched the device necessarily, I feel so rewarded that it's like, we did it. We did it together, right? And I, I wanna share that with others. I think that's part of what I'm trying to do with Bluestocking Health is like we all are part of this community, and it's not that we just like clock in and we, you know, do document control or, you know, work on our risk assessments and, you know, clock out for the day. It's like, no, we, we do all help save lives, right? What a, what a powerful thing to be part of and to know that that's, that's something that you helped do. I don't know. I, I-- maybe that sounds again a little too like look how great we are. Like how, you know, look at, look at how amazing this space is, but oh, it is. It 100% is, so. [00:27:43] Lindsey Dinneen: No, I could not agree with you more. I've, I've always felt the same way of just like, "Okay, I'm, I'm not the scientist, I'm not the engineer, I'm not the regulatory affairs person. I, you know, I play a very small role. I, I help talk about the devices." I sh- you know, the marketing... [00:27:59] Allison Komiyama: Yes. [00:28:00] Lindsey Dinneen: ...And that's, you know, that's, that's not the biggest component of bringing these devices to market by any stretch of the imagination. But I do get to play a role, and I think that is the coolest thing ever. Yeah. [00:28:12] Allison Komiyama: Yeah. Well, and think of-- I mean, I'm gonna be your hype woman for a second because think of all the people who learn about that tech or understand, "Hey, this might be something right for me or my loved one, and if I hadn't learned about it or if I hadn't you know, been exposed to this idea or even knowing that this is in clinical trials, okay, now I'm gonna go look into the clinical trial." Like, that information sharing and even just talking to people or talking to laypeople, like, there's such an important piece of the marketing and the strategy around that, that it's huge. I-- you know, like, directly or indirectly, you've saved a life, right? How cool is that? [00:28:56] Lindsey Dinneen: Yeah, exactly. How cool is that? It's, it's remarkable. Okay. So, all right. Pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. [00:29:09] Allison Komiyama: Ooh, yes. [00:29:10] Lindsey Dinneen: What would you choose? [00:29:10] Allison Komiyama: I mean, all of the things in my header, I think at LinkedIn. So I lo- but I'll, I'll give you a real answer in a second. I think, I mean, all of the... I love my creative outlets. So I love flower arranging, I love face painting, I love chopping wood. I love cross-stitch and needlepoint, and my daughter and I just started doing crocheting together. So I feel all of those things are so I... Not that I'm a master in any of those things, but maybe it's being willing to try new things or having that, I don't feel, I don't consider myself to be a totally fearless person, but maybe channeling some of that fearlessness and a willingness to try new things, and where do we find that and how do we kinda overcome some of that activation energy sometimes to get to try those new things? And I think innovators have that in spades, right? So a lot of the companies that we work with, they're like, "I have an idea, and I don't know if this is gonna work, but I'm gonna go for it." And I think a lot of those cre- it, it's a creative outlet for them as well, right? They're trying something new. And so maybe it's giving people more more support or more confidence that they can try new things. I feel like I don't love change. Like I, I, as a child, I like, I liked the things that just stay the same. But when you look at my arc and my, my origin story, it has been all about very unsettling moments or, you know, like where I was felt, feeling very unsettled or like trying something new, and I'm so grateful for all of those things, and I'm also really grateful that I did it, right? So a- and again, it came down to a lot of my community, my friends, my family that supported me and said, "Yeah, you can do this," right? Having those hype people to help me. So maybe a masterclass in just like being the hype person for people who wanna try new things and try leadership, right? Or try a new path that they hadn't thought about yet. [00:31:24] Lindsey Dinneen: Like, I think to your point too, the more that you're willing to do that and kind of step a little bit outside of your comfort zone and have that potential for quote unquote "failure." But, you know, first of all, the more you do that, the more resilient you get, which means it's easier and easier and easier to take those first steps, right, into something new. [00:31:43] Allison Komiyama: Yes. [00:31:44] Lindsey Dinneen: But I also think-- I, I often think about it in terms of if you can frame those kinds of moments as "I am exploring, this is an exploration" and not like pass-fail, if you're exploring, there's, there's no chance of failure, right? You can, you can explore something and go, "Ugh, not for me," or you can go, "Oh, I actually love this, but it's hard and I'm gonna have to keep working at it." But I think if you can like kind of maybe take it in a slightly different mental direction, that also helps, you know? [00:32:13] Allison Komiyama: Ooh, I like that. Yeah. Like reframing. This is not, this is not something that's gonna, you know, end in failure, 'cause I agree with you. You know, I've called it failure in the past where it's like, "I'm gonna try things. If this fails, then I'll go do something else," right, which then it's not really a failure. You learned something. But it is being able to change directions. It is the ability to say, "Okay, I figured out that I something from that, and then what am I, what am I gonna do with that information?" So I love that. [00:32:48] Lindsey Dinneen: Oh, that'll be a masterclass. I can't wait. okay. And how do you wish to be remembered after you leave this world? [00:32:55] Allison Komiyama: Oof. I hope I... It's, oof. I, I, I hope to be remembered. Yeah. What does my dash look like? Isn't that what they say? Like, what is the dash between the, the birth year and your the year of your death? I definitely wanna be remembered for, like, what my kids are doing, 'cause I'm pretty proud of, like, how badass both of those girls are. But back to your question. I would like to be remembered as somebody who helped innovators and people who were building in the medtech space to grow their brand, to get their message out there, and to really bring awareness to the benefits of medtech. I think it's so easy, as I said earlier, it's very easy for us to get caught up in the bad and the negative, and here are the risks, and we really are so nervous about the risks of things, as we should be. We should be a res- risk-averse population. Like, they-- I don't wanna be walking towards something that's gonna cause me harm. And at the same time, there's a lot of benefit to what we're doing, and I think if we can I guess what we were just talking about, reframe a little bit and say, "Yes, there's risk. There's inevitable things that are gonna happen, but here's the potential benefit," and how do we h- in a human way, weigh those things so that we can get other people to also see that this is something that could benefit them. So it's sharing that message. I wanna know, be, you know, considered somebody who also didn't take herself too seriously, made people laugh. You know, maybe they showed their, their kid a, a video of me doing something silly, but also maybe there's some kid out there that's like, "Oh, she was talking about regulatory affairs. What's that? Maybe I should look into that as a career option." So, yeah, I hope some of it is inspiring to others. [00:34:48] Lindsey Dinneen: Okay. That's, that's great. And then final question: What's one thing that makes you smile every time you see or think about it? [00:34:59] Allison Komiyama: I wanna say my kids, but really it's probably hummingbirds. I have never lost the total fascination with hummingbirds. They are so interesting. They're so beautiful. There's a lot of them here in San Diego where I live, and I kid you not, last year, a mother hummingbird built her nest right outside of our front door. And so we'd have-- we told our guests, like, "Come through the, the side gate 'cause do not walk close to, to our sweet hummingbird." And she laid two eggs, and I was able to watch these two little hummingbirds grow and fledge. And I... It was just one of-- again, it makes me smile every time I think about it. Every time I see a hummingbird, I'm like, "That might be our girl that, that had, that had her nest right here." So yeah, I think that whimsy, the, the, the fun and just how gorgeous they are. They always bring... sparks me joy, for sure. [00:35:58] Lindsey Dinneen: Absolutely. Me too. I adore hummingbirds. One of my favorites. Yeah, love that. Oh my goodness. Well, this has been an amazing conversation. Allison, thank you so much for taking time today to speak with me, and we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. Oh my gosh, and just thank you so much for everything you're doing to change lives for a better world. We're grateful for you. [00:36:42] Allison Komiyama: Thank you. It's so nice to be here. Thank you so much for having me on. [00:36:45] Lindsey Dinneen: Absolutely. Until next time. [00:36:49] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.