Inside AIMD: Building the Future of Implantable Devices with Nicolas Barabino & Antoni Ivarra

In this special episode recorded after the workshop in Barcelona, I talk with Nicolas Barabino and Antoni Ivorra, two of the key organizers behind the 2025 Active Implantable Medical Devices (AIMD) Workshop. We dive into the vision behind this growing event, which brings together top researchers, engineers, clinicians, and entrepreneurs to explore the cutting edge of implantable medical devices. Nicolas and Antoni share insights on the evolution of AIMD technologies, the role of multidisciplinary collaboration, and how this annual workshop is shaping the next generation of innovators. We also touch on the challenges that startups face in the space—regulatory hurdles, IP strategy, and the importance of academic-industry partnerships. Whether you're a student curious about the field or a seasoned expert navigating the complexities of medical implants, this conversation is packed with valuable takeaways from the heart of Europe’s neurotech and medtech community. This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/ Top 3 Takeaways: This year’s AIMD workshop struck a successful balance between clinical research and industry—50/50 over two days. Feedback from both local and international attendees praised the diverse topics, especially the sessions on soft electrodes and innovative implantable technologies. The AIMD Workshop stood out for its diverse programming—not just cutting-edge technology talks like those on soft electrodes, but also valuable discussions on market strategy, startup resources, and IP, including insights from a patent lawyer on what investors really look for. This blend of technical and business perspectives resonated strongly with attendees.  At events like AIMD, aim for just one meaningful 10–15 minute conversation per day—enough to be memorable and lay the groundwork for a follow-up. Quality over quantity builds lasting connections. 1:00 Antoni, do you want to talk about why you were hosting the workshop and what you liked about it? 2:15 Nicolas, do you want to introduce yourself again? 4:30 It was aimed at students, what percentage were students? 5:15 What kind of talks were there? 8:15 Can we define Active Impalntable Medical Device and why was it focused on neurotech? 11:00 Sponsorship by blackswan-ip  11:30 What will next year's meeting look like? 12:45 Which of the topics have some of the biggest future in the field? 17:45 What kind of advice do you have for students who can attend these kinds of conferences? 21:00 Anything that we didn't talk about that you wanted to mention?

In this episode, we sit down with Chad Andresen, Chief Business Officer of Lunosa, to explore a groundbreaking approach to treating obstructive sleep apnea. Lunosa is developing a self-expanding, injectable neurostimulator that aims to replace invasive facial surgeries with a minimally invasive, high-impact solution — tapping into a $10 billion market. Chad also reflects on his time at Stimwave, a pioneering neuromodulation company that saw both innovation and controversy. He shares insights from testifying against Stimwave’s former CEO, lessons learned from the company’s collapse, and how those experiences shape Lunosa’s vision and execution today. This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/ Top 3 Takeaways: User feedback can vary drastically by region — while patients in Mexico and Europe reported positive results, U.S. participants were far more critical and vocal, revealing major usability issues that had been previously overlooked. A major red flag in a startup is when experienced, well-tempered professionals leave quickly and repeatedly — it often signals deeper cultural or leadership issues that young founders may overlook until it's too late. Lunosa developed a novel “nerve net” implant that works like a fishing net—capturing multiple nerve branches responsible for tongue movement in sleep apnea—offering selective stimulation to activate helpful muscles while avoiding unwanted ones. 1:30 Do you want to introduce yourself better than I just did? 3:00 How did your career start? 5:15 How did the founding of StimWave look like? 7:15 How did that ramp up look like? 12:15 How did things go wrong? 17:15 What exactly was the issue that caused all the problems? 20:15 Sponsorship by blackswan-ip  20:45 How did you find out that things had gone wrong? 26:15 What are some lessons learned from this process? 31:30 Do you want to talk about the misalignment of incentives often coming from VC funding? 35:30 Let's talk about LunOsa 44:00 What are some other exciting things coming from LunOsa? 47:00 Anything else that you wanted to mention?

In this special on-location episode recorded in Leuven, Belgium, we sit down with the co-founders and technical leaders of ReVision Implant—Frederik Ceyssens (CEO), Maarten Schelles (CTO), and Laurens Goyvaerts (CSO). The team shares their journey developing a high-density, intracortical visual prosthesis aimed at restoring vision for the blind. From developing reliable insertion technology to achieving long-term biocompatibility in nonhuman primate models, ReVision Implant is at the forefront of neurotech innovation. Tune in to hear about their challenges, breakthroughs, and what’s next in the race to cure blindness through brain stimulation. This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/ Top 3 Takeaways: Future users of ReVision's visual prosthesis express diverse goals—from navigating unfamiliar cities independently to recognizing familiar faces—highlighting the need for customizable solutions with both wide fields of view and high resolution. The team is exploring adaptive algorithms that could allow users to toggle between broad, low-resolution views and focused, high-resolution modes—such as reading letters or recognizing faces—offering personalized visual strategies even if only a few thousand stimulation points are achievable. Restoring vision is one of the most challenging neurotech applications—far beyond simply upgrading existing DBS systems—but taking that bold leap sets ReVision Implant apart in a space where few dare to innovate at this scale. 1:00 Do you want to introduce yourselves and your company? 6:30 What is the device and how is it different than other companies? 11:15 How many pixels or phosphenes are you expecting to get? 16:00 How much processing will be required to handle that many channels? 17:00 What is the form factor of the device? 18:15 How long is the battery expected to last? 23:30 What kind of acceleration would you expect from investment? 26:00 How does your fabrication process look? 31:30 Sponsorship by blackswan-ip  32:15 Are you also looking at vision augmentation? 35:00 There's a large graveyard in this visual neuroprosthetics space, why do you think you will survive where others have died? 40:30 Did some of the other companies have technical issues that caused them to die? 45:30 Is there anything that we didn't talk about that you wanted to mention?

In this episode, we speak with Julio Martinez-Clark, CEO and co-founder of Bioaccess, a contract research organization helping Medtech and Biopharma startups slash months off their clinical timelines. With a focus on Latin America, Bioaccess enables early feasibility and first-in-human trials to be conducted faster, more affordably, and with high-quality data suitable for FDA and EU submissions. Julio shares how their global site network—built over 20 years—helps startups navigate regulatory hurdles, reduce costs, and de-risk innovation, all while improving patient lives in emerging markets. This episode is sponsored by Black Swan IP Top 3 Takeaways:   “The sites and IRBs in Latin America follow international ICH-GCP guidelines—Good Clinical Practice standards set by the World Health Organization. If you're a professional in clinical research, these are the standards you adhere to. As a sponsor, it's your responsibility to ensure that the sites you select, after rounds of interviews and vetting, comply with ICH-GCP. There's also a new development in the region: the Global Clinical Site Certification, an organization based in London that accredits clinical research sites internationally. They're expanding across the Americas, and countries like Colombia and Panama have been especially receptive. For example, we’re currently working on certifying CVAC, a site network in Panama.” For FDA market clearance, sponsors typically need a large, U.S.-based pivotal study. But the FDA may accept up to 30% of that data from international sites—if it follows ICH-GCP standards. First-in-human trials in places like Colombia or Panama can help demonstrate safety and efficacy, supporting an FDA IDE application for a pivotal U.S. study. Many FDA-approved therapies never reach Latin America, simply because manufacturers focus on larger markets like the U.S., Europe, or Japan. Clinical trials provide patients in Latin America with early access to innovative treatments they might otherwise never receive.   0:45 Do you want to introduce yourself better than I just did? 1:30 Why is Latin America better for clinical trials 4:15 How does the speed and cost compare to the US? 6:30 What standard of cleanliness, ethics, and quality can we expect in a country like Panama? 8:45 What kind of capabilities are in these countries? 10:15 Axsoft and Paul LeFloch, previous Neural Implant Podcast guests, utilized your services, can you talk more about their study? 14:15 What was the timeline of that study selection all the way to the end of the study? 15:30 What kind of Institutional Review Boards look over the ethics? Are they internationally recognized? 16:15 Sponsorship by Black Swan IP 20:15 Could you also use this for FDA approval?  22:45 Do you want to talk about the willingness of the patients in Latin America to take part in these trials? 29:45 When should medical device developers reach out to you? 33:30 Is there anything else that we didn't talk about that you wanted to mention?

In this episode of the Neural Implant Podcast, we’re joined by Nathan Piland, CEO of Nunex, a consulting firm that specializes in helping MedTech companies navigate the complex journey from concept to commercialization. With over two decades of experience across regulatory strategy, product development, and market access, Nathan shares invaluable insights into the critical steps for MedTech startups and established companies looking to succeed in today’s competitive landscape. Tune in as we discuss the unique challenges of the neurotech industry, strategic consulting for MedTech ventures, and how Nunex is helping companies grow and scale through a holistic, tailored approach. Top 3 Takeaways: "Some people are saying that the brain is becoming the new heart, referring to the decades-long focus on cardiovascular research and devices, from mitral valve replacements to aortic repairs. However, advancements in heart treatments are becoming incremental, while the brain remains a vast unknown. In fact, we may know less about neuroscience than we do about the heart. This is exciting, though, as it means we have fewer biases about how to solve problems in the brain. There’s a lot of activity in areas like Alzheimer's and Parkinson's disease, with ongoing efforts to improve patients’ lives." "The reason we formed the company was to partner with founders and leaders in the MedTech industry. Like many listeners of this podcast, I’ve been on the other side, constantly receiving sales pitches. We believe we can add the most value by highlighting key insights and trends within the industry." "If I were the CEO of a startup, I would consider doing most of the work in another geography for a fraction of the cost, while still obtaining high-quality data. Then, I would come to the US for a follow-up study. Even if you needed to do a 50-patient study to confirm results with a US-based population to satisfy the FDA, it would be much cheaper, faster, and more cost-effective than conducting a large-scale trial here in the US with all the associated costs and challenges." 0:45 Do you want to introduce yourself better than I just did? 1:30 How did you get into medtech consulting? 5:15 Why did you decide to work with startups? 7:15 What are the 7 dimensions and what are the order of these? 12:45 What does a typical workflow look like with a company? 19:30 Is neurotech different or unique compared to other types of medtech? 23:45 Do you want to talk about your newsletter and conference also? 30:00 And you'll have another conference this year too? 32:00 Malaysia sounds great but are there any drawbacks to working there? 36:45 With the new administration what is your prognosis on funding and medtech development? 41:15 Anything that we didn't talk about that you wanted to mention?

In this episode, we welcome Prof. Dr.-Ing. Maurits Ortmanns, a leading expert in ASIC design and professor at the University of Ulm, Germany. With a distinguished career in microelectronics, Dr. Ortmanns has contributed extensively to the development of integrated circuits for biomedical applications. He shares insights into the critical role of ASIC (Application-Specific Integrated Circuit) design in advancing neurotech implants, focusing on low-power, high-speed circuits that are essential for optimizing the performance and reliability of these devices. Dr. Ortmanns also discusses the challenges and future of circuit integration in neurotechnology. Top 3 Takeaways: "Each ASIC is very low in cost because the development cost is spread across millions of units. The actual production cost is minimal; the primary expense lies in the development time until the first chips are produced and ready for manufacturing." "For an inexperienced engineer, it typically takes about six months to a year to design the blueprint for the chip. Then, depending on the manufacturer, it takes an additional four to six months for the actual fabrication of the ASIC. Finally, you would need another one to two months for testing, so the total turnaround time for a small chip is approximately one and a half years." "Let's take the example of a neuromodulator. You need recordings or data from neurons and stimulation data going to the neurons, so you essentially have these two components. Then, you encounter challenges like stimulation artifacts. One person might focus on eliminating the stimulation artifact in the recording channel. That requires additional algorithms or hardware, and the data needs to be digitized, which is another task. You may also have someone working on a compression algorithm and building digital circuitry to compress the raw input data. Then, there’s the data interface, power management, and wireless energy delivery. Each person works on their specific innovation, and if everything is well-planned and lucky, all these pieces can come together to create a complete system. However, sometimes you simply don’t have a breakthrough idea for power management or communication." 0:45 Do you want to introduce yourself better than I just did? 3:15 What is integrated circuit design? 7:30 What are ASIC's? How are they used in neurotech? 10:15 How does the million dollar fab cost get split into each chip? 11:30 What are typical functions of ASICs? 14:30 Why does the development time take so long? 18:15 So most of the libraries you use are your own and you don't use external ones? 19:45 To what extent is this modular? 22:15 What is the timeline of each of the sections of development? 27:45 How does it work managing IP from your company and your University? 30:45 Are there any Open Source initiatives in Europe for ASICs? 33:00 How many people in the world do this kind of work? 35:45 What is a good pathway for those looking to get into this kind of work? 38:45 How early should companies start talking about designs? 40:15 If you 10x the money could you make it go faster? 41:30 If people want to reach out how do they do so? 42:15 Anything else that you wanted to mention?

In this episode of the Neural Implant Podcast, we welcome Dr. Eugene Daneshvar, founder of Black Swan Intellectual Property (BSIP), a boutique law firm specializing in intellectual property for neurotech and medtech innovations. With a background in biomedical engineering and law, Eugene has a unique perspective on protecting the cutting-edge ideas that drive the future of healthcare technology. After years of working at a larger firm, Eugene founded BSIP to provide more accessible, fair, and transparent pricing for IP services, moving away from the traditional hourly billing model. In addition to his work in intellectual property, Eugene also offers strategic counsel for fundraising and business development, helping startups navigate the complexities of commercialization in the medtech and neurotech space.   Top 3 Takeaways: "It’s difficult to change large organizations. I had tried to build a neurotech-focused practice, but my previous firm wasn’t on board. The firm was primarily focused on pharma, with much deeper pockets than neurotech, and they controlled my hourly rate, which reached $1200 an hour. It was too steep for my clients in medical devices, so I decided to create a firm that would be more accessible and help those startups – I became an entrepreneur myself." "The most exciting part is that I switched to flat-fee billing, so no more billable hours. Everyone dislikes billable hours, and this approach creates a win-win situation for both myself and my clients. It provides predictability in costs, and it saves me time since I no longer have to track every minute of my work." "I offer deferrals based on what clients need—whether it's 30 or 90 days, or until they secure funding. Sometimes, I even take shares instead of cash, depending on the opportunity. As an angel investor with Life Science Angels, I help life science startups raise capital, typically between $200,000 and $1 million, by ensuring they are prepared for investment. 0:30 Do you want to introduce yourself better than I just did? 3:15 What are you specializing in? 4:15 Why do you think you're competent in this field? 9:30 What is a typical price for your services? 12:45 What are some other services that a neurotech company might need? FogartyInnovation.org 16:30 How does being a small law firm affect reputation? 22:45 What is missing most? Or what is something that you wish people would know? 27:45 Is using AI an issue more for generating the patent claim or writing the claim? 31:00 So you feel confident that your job is safe from AI?  

In this episode of the Neural Implant Podcast, host Ladan Jiracek engages in an insightful dialogue with Andreas Forsland, founder and CEO of Cognixion. The discussion covers Cognixion's pioneering augmented reality headset with EEG sensing, designed to enhance communication for individuals with speech and motor challenges. Andreas describes the journey from creating a speech augmentation device to developing a versatile platform, the Axon-R, which is now being utilized by health systems and researchers for various clinical applications. They explore the platform's form factor, capabilities, and its role in empowering others to create specialized applications.    Top 3 Takeaways: "We aimed to make it easy for both non-technical and technical users to build simple research applications as well as complex, immersive commercial applications. Initially, it was an internal product we developed for rapid prototyping and exploring neurophysiology. But we realized many others wanted the same capabilities to build their own apps." "Go ahead and integrate with Apple Vision Pro or a Meta Quest device, but be aware that you're going to face a lot of problems. The clinical trial process is expensive and time-consuming, and what we've found is that some people who’ve tried this route end up with only 10 to 15 percent usable data. Wasting 80 to 85 percent of your data because of poor technology or failure to meet IRB standards for medical safety and efficacy is a huge waste. If you're pursuing anything in healthcare, you need to build on a reliable platform like Cognixion." "You could invest in 10 software-as-a-medical-device (SMD) applications, which are subscription-based or software-based apps that deliver clinically valid outcomes. Building and validating such an application might cost anywhere from $3 to $10 million to bring it to commercialization. In contrast, building a traditional medical device could cost anywhere from $25 to $200 million, usually for just one indication. The key cost savings here is that you don’t need to invest in bespoke hardware—we've already invested over $25 million in developing the validated hardware and platform."   00:45 "Do you want to explain your product and introduce yourself better than I just did?" 04:45  "So the platform, what does it look like? What's the form factor? 10:00  "Where would where would they likely use it?" 14:45 "How does it compare to implantable technologies like Synchron or Neuralink? Obviously, with a wearable-only technology, the fidelity must be lower, correct?" 25:15 "What kind of savings does this represent? How much does it help others who want to develop this type of technology? 28:45  "So how would you prevent other companies from doing something like this?" 33:45  "What role does AI play in your guys company?" 39:00  "Is there anything that we didn't talk about that you wanted to mention?"  

In this episode of the Neural Implant Podcast, host Ladan speaks with David McMillan, the Director of Education Outreach for the Miami Project and a Research Assistant Professor in the Department of Neurological Surgery at the University of Miami. They discuss the Miami Project's work, particularly in spinal cord injury research and neuroprosthetics. Topics include clinical trials, combining therapies, regulatory challenges, and the importance of rehabilitation in conjunction with therapeutic technologies. 00:00 Introduction to the Neural Implant Podcast 00:16 Meet David McMillan: Director of Education Outreach 01:07 The Miami Project to Cure Paralysis 03:36 Clinical Trials and Patient Recruitment 08:01 Innovative Neurostimulation Projects 20:54 Challenges and Future of Neuromodulation 24:17 Role of Director of Education and Outreach 28:21 Final Thoughts and Conclusion

I n this episode of the Neural Implant Podcast, host Ladan welcomes Javier Schandy and Nicolas Barabino from Focus, an engineering services company based in Uruguay. They discuss their work in firmware, hardware, and software development for medical devices, emphasizing their specialization in wireless communications and test automation.  They also explain the benefits of contract engineering, the challenges they face, and highlight an exciting project involving an injectable neurostimulator. The conversation covers the history of neurotechnology development in Uruguay, the process and dynamics of working with clients, and the adaptability and innovative spirit of their company. 00:00 Introduction to the Neural Implant Podcast 00:18 Meet the Guests: Javier Shandy and Nicholas Barabino 01:05 Focus: Engineering Services in Medical Devices 02:58 Project Onboarding and Development Process 06:06 Specialties and Expertise in Neurotechnology 09:38 The Journey into Medical Devices 13:41 Uruguay's Legacy in Medical Devices 20:37 Challenges and Advice for Startups 23:05 Flexible Project Management and Cost Considerations 27:51 Conclusion and Final Thoughts