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 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, 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, 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

Today's guest is Stephen Ho from Blackrock Microsystems. While we've featured Blackrock guests before, Stephen's appearance today is driven by his podcast, Neurratives, where neurotech-inspired movies are reviewed and discussed.

 

  Top 3 Takeaways:

• "Our goal for the podcast isn't necessarily to be overly technical, requiring a neuroscience degree to understand. We're often deep in the subject matter and may get a bit jargony, but broadly, we aim to be accessible without pretending to be accomplished neuroscience researchers."
• “Due to the subject's nature, movies dealing with neuroscience themes often lean heavily towards science fiction. So, I make a conscious effort to seek out romantic comedies, medical dramas, or family dramas as a palate cleanser between sci-fi films.”
• “I tend to be relaxed regarding accuracy in science and technology in movies, though I do point out inaccuracies when I notice them. However, I don't always see this as detrimental to the movie itself. Some tropes bother me, like percutaneous connectors seen in "The Matrix" and "Ghost in the Shell." They seem impractical and unsanitary.”

 

2:00 Let’s hear about the Neurratives podcast

4:14 What does a normal podcast episode look like?

7:30 What are some notable movies?

10:30 What are your qualifications to talk about neurotech movies?

12:15 Did you ever feel imposter syndrome?

14:00 Will you ever run out of movies?

16:00 Would listening to Neurratives be better before or after watching the movie?

16:45 What should movie directors either start or stop doing for neurotech movies?

 21:15 Anything else that we didn’t talk about that you wanted to mention?

Eugene Daneshvar is a University of Michigan PhD graduate working on thin film neural implants but has since transitioned into the legal side of things having passed his bar exam and working with Wilson Sonsini as a patent attorney. This interview took almost 2 years to get done but we're glad we were able to do it!

 

  Top 3 Takeaways:

• "I think the main thing I'll say is you don't undermine your valuation by not having an informed and intentional patent strategy, and you don't have to go cheap. You know, I feel that you have to bootstrap, but if you work with certain law firms that are very entrepreneurial friendly, and my firm is not the only one, but I think that is a general statement, which is, you know, work with somebody who understands your business model. But then, secondly, work with somebody who understands your technology as well."
• "I want my clients to understand that I'm building something valuable for them. Let's ensure all that value is captured in the application. If not, it risks not just their business, but also their motivations for it. They aim to translate this information and idea to help a certain subset of the patient population."
• "Some people cut corners without considering the broader strategy implications. I suggest working with individuals who are willing to learn about the process. We're all part of the same community, and if you're listening to this podcast, you're part of mine. I want the best for you, so don't hesitate to reach out."

 

0:45 Can you introduce yourself better than I just did?

 5:15 Was it your idea from the beginning to do both a PhD and law school?

7:15 Why are patents important in the neurotech field?

11:30 What are some big mistakes you’ve seen in the neurotech entrepreneur field?

17:30 Is it better to have a strong lawyer or one that knows your field?

21:00 What is the process for a student wanting to spinoff a technology?

28:00 Have you seen deals go badly because of legal issues?

32:45 Is there anything that we didn’t cover that you wanted to mention?

 

 "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?