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?

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?"