Jon Speer on how Quality Management Software for Medtech companies raised $120 Million

 "Welcome to today's episode! Our guest, Paul Le Floch, co-founder and CEO of Axoft, brings innovation to neural implants. With roots in France and a Harvard PhD, he's leading groundbreaking work. Welcome, Paul!"  Top 3 Takeaways: "It's a good time to ask the question: What if we could develop solutions tailored for this problem instead of borrowing from the semiconductor industry? That's what Axsoft is about. We emphasize developing soft materials that offer better long-term biocompatibility. Additionally, these materials are suitable for micro and nano fabrication and remain stable inside the brain." "The advantage is that when we identify something that doesn't work well, we can modify it because we designed the materials. The key is that we've developed an innovation that functions effectively, but we also acknowledge that it's not the final version of the system. The difference is that we can revisit it at the polymer chemistry level and alter the material's composition, structure, or introduce additives to enhance stability or mechanical properties." "At early stage, there is iteration. There is improvement over time. And at some point you need to take this leap of faith that your technology actually has a good edge, that you have enough, you will have enough resources to make it competitive. And I think we were confident enough about that and about our approach."   0:30 Can you introduce yourself better than I just did? 1:00 Is Axoft a spinoff? 5:00 How do you know your material is better? 9:00 Why did you go the startup route vs the academia route with this technology? 12:30 How do you let investors know that this is a long term startup? 14:00 Why did you choose the dilutive vs nondilutive route? 15:30 What indication is the material best for? 17:00 Where are you guys in terms of the lifecycle? 19:45 How big is the team and what are current challenges? 22:30 Where do you see neurotech in 10 years? 23:45 Anything that we didn’t talk about that you wanted to mention?  

Today’s guest is Christine Schmidt who is a University of Florida faculty member and former department share who works in regenerative neural tissue engineering. Top 3 Takeaways: "We're trying to create scaffolds that can be templates for the body to repair itself, to grow around, and ultimately become natural tissue, seamlessly integrating with the body's own." "Other faculty were discouraging. This is because academia tends to prioritize scholarly pursuits such as papers and grants, often undervaluing applied work and its real-world applications."  "Our clinical collaborator actively participated in the lab alongside Sarah. Together, they would work on batches, with Sarah creating formulations and providing immediate feedback based on the tactile experience. The collaborator would discern whether a material was suitable for surgical use, offering invaluable insights into the practicalities surgeons face." 0:45 Can you introduce yourself better than I just did? 1:15 What is tissue engineering? 5:00 How did you get into this? 8:30 By focusing on entrepreneurial endeavors you were at risk of not getting tenure, how did you still get it? 14:15 Which was more useful for your career, entrepreneurial or academic? 16:45 How was your technology licensed?  22:15 Do you want to talk about your other startup, Alafare? 32:30 You then moved to Florida and then eventually became department chair, why did you do that? 36:45 How did you do the department chair and research at the same time? 37:45 Is there anything else that we didn’t talk about that you wanted to mention?

Welcome to the Neural Implant Podcast! In this episode, the podcast team presents a live panel recording from the Bio L Conference at the International Winter School on Bioelectronics in Austria in March 2024. Hosted by Ladan, the panel discusses various types of neural implants with esteemed guests: Drs . Jonathan Viventi (LCP neural implants), Tracy Cui (PEDOT electrode coatings), Ellis Meng (parylene neural implants), and Ivan Minev (PDMS neural implants). Tune in as they explore the fascinating world of soft implantable electrodes and brain-nervous system interfaces.   Top 3 Takeaways: “In the next five or 10 years, I anticipate that advancements in human neural implants will resemble those we've observed previously. I don't foresee any radical changes in materials or physical attributes. The neurosurgeons I collaborate with prefer implants that aren't excessively flexible or thin to avoid tearing during surgery.” “The first time we delivered an implant to a clinician, these devices were carefully handled by my students. No one dared touch them; they were like sacred objects entrusted to the grad students. When the surgeons got hold of them, they were shocked – bending them in ways we never imagined. Handling these inconsistencies is a crucial aspect to consider, bridging the gap between expectation and reality.” "Everything new is something old that is well forgotten" 3:15 Do all of you want to introduce yourselves? 10:30 What’s a good way for trainees to stay on top of everything there is to learn? 13:45 What is the ideal neural implant and what is the 5-10 year plan for developing these? 20:00 Each of you has a different favorite material for neural implants, do you want to talk about that? 29:45 What motivates you in this field? 35:30 How do you take clinical translation into account in your research? 40:15 What challenges or embarrassing moments have you had in your career? ***Audience Questions*** 43:30 What is your experience and challenges in patenting your electrodes and research? 46:00 What’s the point in doing research if other companies are able to raise significantly more money than we can? 49:00 How do you address the scalability of manufacturing electrodes? 51:15 How groundbreaking do your ideas need to be to be successful? 54:30 How do you deal with paper submission processes that have gone badly? 58:00 How do you deal with a  double blind review? 59:00 What’s the most difficult aspect of supervising graduate students? 1:02:00 When can we expect neural implants that interface with all of the neurons in our brain? 1:06:15 How do you deal with materials that aren’t certified for clinical translation?  1:07:45 If you had a magic wand / unlimited funding, what would you do? 

In today's episode, we're joined by Carles Garcia-Vitoria, a seasoned pain physician with a unique approach to his work. With extensive experience in regional anesthesia and pain management, Carles shares insights gained from his years of practical experience as he pursues his PhD in Spain.  Top 3 Takeaways: "We believe we have the opportunity to target the site of action more effectively. That's why we've founded Spinally, the startup we're currently leading. Our goal is to pioneer intrathecal spinal cord stimulation." "The Dura Mater is highly elastic, closing approximately 80-90% within the first 30 seconds after trauma. Additionally, with improved intrathecal access and emission capabilities, we can utilize thinner implants—reducing implant thickness from 1.3 to 0.5 millimeters. This minimizes trauma to the meningeal sac even further." "We can leverage new fabrication capabilities to minimize implants and achieve highly effective pain relief. Our models, along with others, indicate that we can stimulate deeper layers of the spinal cord with intrathecal electrode positioning, enhancing our ability to listen to deeper neuronal tracts. This advancement is poised to make significant waves in the pain management field within a year." 0:45 Can you introduce yourself better than I just did? 1:15 What advantages of neurotechnology do you see in the pain market?  3:15 What does the pain treatment process using neuromodulation look like? 6:45 How is closed loop stimulation changing your work? 8:30 You’re involved in a startup to better listen to the spinal cord, can you talk about that? 11:30 Why hasn’t this been done before? 14:00 Where in the startup process are you? 15:30 Where are you getting the leads from? 16:30 You guys are raising money, can you talk about that? 18:30 Crowdfunding for medical devices is new, have you seen these before? 21:00 Is there anything that we didn’t cover that you wanted to mention?  

Steve Goetz is now the Chief Technology Officer at Motif Neurotech which is developing a minimally invasive neural implant for the treatment of depression and mental health issues. Steve was at Medtronic for 26 years before moving over to the startup landscape. Top 3 Takeaways:  "Starting a big program that you don't know how to finish is a very expensive endeavor, and so you want to really shake out all the science risk, all the technology risk,  be pretty sure you can execute a thing before you turn on that big engine because it's expensive once you go" "We know stimulation of the dorsal lateral prefrontal cortex is very efficacious in treatment-resistant depression.  Our question is, can we develop a cranial stimulator that can do that in the comfort of a patient's home on demand and with a dosing profile that is matched to that patient's acuity and severity that both treats depression and at some point in the future turns into a maintenance therapy that prevents relapse altogether. And what that looks like to us is a pea-sized stimulator that fits in a minimally invasive burr hole that sits on top of the dura, so not brain penetrating,  that delivers this therapy powered externally from a wearable, like a hat or a headband." "For deep brain stimulation, there's a subspecialty of neurosurgery called functional stereotactic neurosurgery with on the order of hundreds of surgeons in the US. There are more that have the specialization to make a burr hole. You go from a few 100 to several 1000 people in the US who can do a burr hole. Over 200,000 burr holes are made in a given year in the US" 1:00 Do you want to introduce yourself better than I just did? 3:00 What was that smaller group within Medtronic? 8:30 What does the organizational structure look like at a place like Medtronic? 11:30 What do those teams look like? 16:00 Is each team working on a project? 18:15 CEITEC Nano Ad Sponsorship 18:45 What is Motif all about? 24:15 What is the success rate of TMS and what do you hope to achieve? 25:15 This isn't brain surgery but it is close to it, what's involved in this? 29:15 Could this surgery be done by a lower-skilled person than a neurosurgeon? 31:00 How does insurance reimbursement look like for Motif? 36:15 Why is this technology possible now?  41:30 Your technology seems bikini-ready 42:45 What is the progress of your company? 45:00 What's the small company vs large company life like? 47:30 How long do big decisions take in a big company? 48:45 How is the pace in a small vs small company? 51:00 What is the perfect recipe for working in a meaningful company vs learning in another company? 53:45 Anything else you wanted to mention? 

Dr Eric Daniel Glowacki is a research group leader at the Central European Institute of Technology (CEITEC) located in Brno, Czech Republic. There he studies neural implant fabrication and materials specializing in silicon, parylene, and polyimide devices. He has also started to designs and fabricate devices on a contract basis for other research groups and companies. And, his institute is the one that has been recently sponsoring the podcast! This podcast is sponsored by CEITEC Nano, check out their Neurotech Device Manufacturing Capabilities here Top 3 Takeaways: "You can just buy stuff on the internet very simple red LED arrays. So you don't have to bother with aiming because you just put this this light source roughly over the area of interest and, and you can hit the target without having to try very hard." "Most of the time we're pretty fast. If someone sends us a design we can print photo masks in a day or two. That's the slowest step." "And it turns out that the beat frequency can actually stimulate neurons. So you can use these high frequency carrier waves to get in. And then use this constructive interference to actually stimulate to stimulate excitable tissue." 1:15 "Mr. Sponsor, do you want to, do you want to talk about you yourself? What your institute does?" 3:00 "Photovoltaic, transcutaneous neurostimulation. What are the details of that? " 5:15 "How does this compare to other wireless ultrasonics, magnetics, anything else?" 8:15 "What kind of light density would you need?" 9:15 What was your career arc? 12:00 Do you want to talk about Polyimide, Paryle and these other materials? 16:15 CEITEC Nano Ad Sponsorship 17:00 "Talk about your services a little bit" 19:15 What does the contracting process look like if someone wants you to make them devices? 21:45 "Can you talk about the price differences?" 23:30 "Have you thought about opening it up to neurotech companies?"  25:30 Do you want to talk about your success despite you having moved around to many institutes? 28:00 "What do you see as the future of neurotech?" 32:15 "Is there anything that we didn't talk about that you wanted to mention?"

Dr. Gene Fridman is an Associate Professor in the Department of Otolaryngology Head and Neck Surgery and also has appointments with the Department of Biomedical Engineering and the Department of Electrical and Computer Engineering. His research is in the areas of bioinstrumentation and neural engineering. In this episode we talk about his freeform nerual stimulator which allows for DC and any other waveforms without any electrolytic effects on the electrodes. This opens up many possibilities for neural stimulation. We also talk about his startup Aidar which is like a 'tricorder' all-in-one medical diagnostic tool. This podcast is sponsored by CEITEC Nano, check out their Neurotech Device Manufacturing Capabilities here Top 3 Takeaways: "The reason why they have to use pulses at the metal electrodes is that if you deliver electrical current for too long to a metal electrode that is implanted in the body, what you're going to get is you're going to get electrochemistry, the first thing that will happen is you're going to start forming bubbles because you're going to split water. It's electrolysis. So you clearly don't want to do that in the body. They have to use pulses charge balanced by phasic pulses otherwise, you're going to have these electrons jump across and cause chemical reactions" "By introducing hyperpolarizing current to the peripheral nerve what we're seeing is it's affecting the small caliber neurons much more so, which carry pain much more so than the larger neurons that carry other information. And so we're able to block pain at the peripheral nerve. We didn't know about this. It was a surprise to us."   0:45 "Do you want to introduce yourself better than I just did?" 3:00 Do you want to talk about your device able to talk to both ions and electrons in neurotech? 7:00 Was a DC bridge rectifier the inspiration for this? 9:15 What is possible with these new waveforms? 15:15 "How big is it? And why does it need to be that size?" 21:45 CEITEC Nano Ad Sponsorship 22:15 Do you want to talk about your startup company, Aidar? 24:30 Are you doing any nerve stuff with the 'tricorder?' 26:30 How are you able to manage the time with the startup? 27:45 How did you get the project's initial data?

Kurt Haggestrom comes on to talk about the latest new from Synchron, which has developed the Stentrode as well as the new Synchron Switch. Kurt talks about his new role as Chief Commercial Officer and where the company is heading. ***This podcast is sponsored by CEITEC Nano, check out their Neurotech Device Manufacturing Capabilities here*** Top three takeaways:  1. "The beauty of this approach is that the blood vessels are an amazing place. To be able to put implants and we've, we're leveraging really decades of science and medical devices in say, the coronary space and the heart space. We know that these types of materials heal very well within the vasculature. It's a very novel approach and really scalable because there's a lot of physicians that can do this type of procedure."  2.   "Syncron is developing we're calling it the Synch Switch. So it is an endovascular brain-computer interface system. This system will allow patients who are suffering from paralysis to connect into the digital world, whether it's banking, communication by using a smartphone or computer.  3. "A key part of, I think these types of novel technologies is to think about "how do people afford this when it does get to market?" And with the patients that we're focused on today, many of them use Medicare to be able to afford these technologies. It's critical that we think about our partnership and in working with CMOs to make reimbursement possible for these type of technologies.   [1:15] "Do you want to give a refresher on what Synchron does?" [3:00]  "What are some exciting news that comes out of Synchron?" [4:15] "So what is Chief Commercialization Officer and why is it necessary, especially for a company like Syncron which isn't commercial yet?" [5:45] CEITEC Nano ad sponsorship [6:15] "What's your story arc?" [8:30] How are you navigating reimbursement? [9:30] What is your timeline for commercialization? [10:45] "What are some security protocols, that you're putting into place?" [12:30] "What are some of your biggest challenges nowadays?"  [16:15] How many patients were in your study? [16:30] How large is the target market? [18:15] Does this have other application potentials outside of locked in patients? [19:15] "Is there anything that we didn't talk about that you wanted to mention?"    

Pawel Soluch is a returning guest who goes over his work at Neuro Device, then his consulting at NeurotechX Services, and now finally he talks about the Medtech Coaching program that he is launching with me! This is a sponsorship for Medtech Coach Top 3 Takeaways: Pawel and I (Ladan) are launching the Medtech Coaching program which will be aimed at helping medical device executives gain success in their businesses Coaching is different from consulting in that we do not generate anything for you but instead help you to become the best medtech executive you can possibly be In addition to group coaching we will also be offering individual coaching and also a retreat in January 2024 0:45 Do you want to reintroduce yourself 2:45 Do you want to talk about Neuro Device? 5:15 Do you want to talk about your work as a consultant? 7:15 Do you want to talk about your experience in my original group coaching? 9:15 What's the difference between coaching and consulting? 12:00 "Who is this for and who is it not for?" 15:00 What was the return on investment for the group coaching that you attended? 19:15 What does the individual coaching look like? 23:00 What does the retreat look like? 24:30 What's the role of trust in the meetings? https://medtechcoach.com/

Dr Mounya Elhilali did the keynote talk at the NER Neural Engineering conference in Baltimore in 2023. I was able to sit down with her and talk to learn more about her auditory processing selectivity research. Top 3 Takeaways:  Nurses especially can get used to beeping and alarms which can be dangerous for patients. "Under anesthesia, you see some basic responses, but they are different than when you engage the, let's say, an animal in an awake state, and then when they are awake and actually behaving and engaging with the system" Audio recordings can be tuned to remove ambient noise but they need to be perfectly calibrated to distances between microphones. 0:45 "Do you want to describe your work a little bit?" 3:00 Can you talk about the Cocktail Party Problem? 4:30 How are alarms and beeping override our attention 8:30 How do you gather your data, what kinds of devices? 10:00 What is the role of awake vs non-awake states in auditory processing? 11:15 How did you get into this? 13:00 How are you involved in the translation of the science? 16:15 Why are recordings harder to hear than in real life? 17:15 Is there anything we didn't talk about?