Neural Implant podcast - the people behind Brain-Machine Interface revolutions – Details, episodes & analysis

In this episode of the Neural Implant Podcast, host Dr. Ladan Jiracek speaks with Ali Samiian, founder of Poplar Access Advisors, about one of the most overlooked challenges in neurotechnology and medical devices: reimbursement.

Ali has spent over 20 years working across pharma, medical devices, and neuromodulation, including leadership roles at Abbott, Novartis, and Cala Health, where he helped secure reimbursement for a first-in-class wearable neuromodulation therapy for essential tremor. In this conversation, Ali explains why FDA approval alone is often not enough for a company to succeed, and why coding, coverage, and payment strategy must be considered from the earliest stages of device development.

The discussion covers reimbursement strategy for neurotech startups, how clinical trial design impacts commercialization, lessons learned from Cala Health, home-use neuromodulation, CMS and Medicare pathways, and why many promising neurotechnology companies fail despite having strong science and working products.

Key Takeaways
1. FDA approval does not guarantee commercial success. Many neurotech startups mistakenly believe FDA clearance is the finish line, when reimbursement is often the real challenge. A device can be safe and effective yet still fail commercially if insurers refuse to pay for it.

2. Reimbursement strategy should shape product design early. According to Ali, critical reimbursement decisions are often locked in years before launch through choices around device form factor, clinical trial design, and regulatory pathway selection. Waiting until after FDA submission can force companies into expensive redesigns and delays. Ali recommends founders begin thinking about reimbursement during product design, regulatory pathway selection, clinical trial planning, and fundraising, before key commercialization decisions become difficult to change.

3. Neurotech companies must think beyond efficacy alone. Payers want more than proof that a therapy works. They care about long-term outcomes, comparators, durability, site-of-care economics, and whether the product delivers clear value for money.

4. Cala Health helped prove wearable neuromodulation can be reimbursable. Ali describes how Cala Health overcame major reimbursement hurdles by differentiating its tremor therapy from simple TENS devices, ultimately securing substantially higher reimbursement and validating a commercial path for wearable neuromodulation.

5. Neurotechnology may be entering a commercialization inflection point. With advances in closed-loop systems, home-use therapies, and successful acquisitions in the space, Ali believes neurotechnology and electroceuticals are approaching a "golden age" where investors and payers increasingly recognize their value.

Episode Timestamps

0:15 - Can you introduce yourself and explain what Poplar Access Advisors does?

2:30 - What exactly is "reimbursement" in healthcare?

4:40 - How do coding, coverage, and payment work together?

6:05 - What are the biggest commercialization mistakes medtech startups make?

10:20 - When should founders start thinking about reimbursement?

13:55 - How did Cala Health secure reimbursement for wearable neuromodulation?

20:10 - Is reimbursement becoming more unified or more fragmented?

22:20 - How do companies actually communicate with payers and CMS?

23:50 - What is different about reimbursement for neurotechnology and neuromodulation?

26:20 - What mistakes do neurotech founders repeatedly make?

27:35 - Are we entering a golden age for neurotechnology and electroceuticals?

In this episode of the Neural Implant Podcast, host Dr. Ladan Jiracek speaks with Ellyn Ito, CEO and co-founder of Innerstill Health, about their wearable neurotechnology platform and flagship product, MindVibe. This non-invasive device combines vagus nerve stimulation and acupressure-based neuromodulation to help regulate the body's stress response and improve overall wellness.

Ellyn shares how MindVibe is designed to promote calm, enhance focus, and improve sleep quality through ultra-low electrical stimulation that users don't even feel. The conversation explores the science behind multi-mode stimulation, why avoiding sensation may actually improve outcomes, and how Innerstill is navigating the path from wellness device to potential clinical applications.

Key Takeaways

1. MindVibe focuses on regulating the nervous system—not treating specific diseases. As a wellness device, MindVibe targets stress, anxiety, and sleep by activating the body's "rest and digest" response rather than claiming to cure medical conditions.
2. Multi-mode stimulation may be the key differentiator in neuromodulation devices. By combining vagus nerve stimulation with ear-based acupressure points across multiple frequencies, MindVibe aims to avoid saturation and improve effectiveness across different users.
3. "Do no harm" design avoids the sensory discomfort common in other devices. Unlike many stimulators that produce tingling or muscle twitching, MindVibe operates below sensory thresholds—reducing cortisol responses and improving user adherence.
4. Early results suggest improvements in calm, sleep, and focus. Users report reduced anxiety, better deep sleep, and increased focus—likely tied to vagus nerve activation and improved neurohormonal regulation.
5. The company is using a "wellness-first" strategy to accelerate adoption
   Innerstill is launching through clinics and consumer wellness channels before pursuing FDA pathways for broader clinical indications like addiction, ADHD, and neurological disorders.

Episode Timestamps

0:17 – Introduction to MindVibe and Innerstill Health

1:00 – What does "feeling better" actually mean? (calm, sleep, focus)

3:30 – Is this like alcohol or cannabis—or something different?

6:00 – What does the device look like and how is it worn?

8:00 – How long do you need to use it and what's the protocol?

9:30 – Why avoid sensation in neuromodulation devices?

11:00 – Clinic rollout and early user feedback

12:15 – Why launch as a wellness device instead of FDA first?

14:15 – Future plans: non-invasive deep brain stimulation

18:15 – Origin story: from pediatric pain treatment to neurotech platform

21:30 – Why other vagus nerve stimulators didn't work as well

24:00 – Scaling the company and future applications

In this episode, we dive into the world of European intellectual property and medtech innovation with Dr. Christian Wende, a German and European Patent Attorney specializing in medical technology at DTS. With a background in mechanical engineering, a Ph.D. in liver dialysis research, and a Master of Laws in European IP law, Christian brings a rare and powerful combination of technical, legal, and clinical insight.

We explore how startups and investors should think about IP strategy in Europe, the impact of the new Unified Patent Court (UPC), the nuances between U.S. and EU patent landscapes, and how IP due diligence is handled during VC rounds and M&A activity. Whether you're a founder, investor, or innovator in medtech or neurotech, this episode is packed with actionable insights.

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:

• When looking for a good IP lawyer, don't try to search blindly—ask founders who've successfully done it before. You'll often hear the same trusted names. And even if those lawyers are conflicted, they'll usually refer you to a trusted colleague. The IP community is small and highly referral-driven.
• Becoming a qualified German and European patent attorney is a long and rigorous journey—often taking over 14 years. It includes a PhD, a three-year legal apprenticeship, two bar exams (German and European), and additional certification for the Unified Patent Court. Only about 25% of German candidates pass the European exam on their first try.
• Investors expect transparency and a plan—especially when IP litigation risk is involved. Hiding potential legal issues is a red flag that can derail multimillion-dollar investments, particularly in later-stage rounds. For high-stakes backers, surprise IP battles are deal-breakers, not details.

1:30 What is a patent and how is it different in Europe vs the US?

3:30 How far in advance should you be thinking about European patents?

8:15 How did you get into patent law?

10:00 What kind of education is necessary for this?

14:30 What was your role in the Sapiens DBS IP portfolio?

17:15 Sponsorship by blackswan-ip 

17:45 What are common issues especially in Merger and Acquisition deals?

27:15 What is one of the biggest mistakes you see neurotech companies do?

30:00 How do you recognize good legal counsel?

32:30 How do your Japanese roots fit into everything?

36:00 Are you knowledgable about the Asian side of medtech?

38:00 Is there anything that we didn't talk about that you wanted to mention? 

Blythe Karow is a medical device veteran who is now the cofounder and CEO of Evren Technologies, a medical device company making a wearable Vagus Nerve Stimulator to help with the problems brought about by Post Traumatic Stress Disorder (PTSD).

Top 3 Takeaways

• Not only veterans but first responders often get PTSD and 1/9 women will have it at some point in their lives
• Stimulating the auricular (ear) branch of the Vagus nerve has fewer side effects but with a calming effect on the body
• Diagnosing and curing PTSD is very difficult and subjective

1:15 "Do you want to introduce yourself and the technology?"

2:30 "You spun out of the University of Florida and then you were able to license it, what did that look like? "

3:30 "So you have some background in medical devices, you saw the potential in this and then you were looking to do something new? 

5:00 "What were you looking for and what were the acceptance criteria?"

6:00 "So how does this work? What are some of the effects of vagus nerve stimulation?"

9:00 "So it is this calming effect, you're able to flip that stress response back to normal with the PTSD patients. Is that a one-time thing? Is that a one-time flip or does it have to be re flipped?"

11:00 "PTSD is very hard to quantify, right? How is that currently done?"

13:00 "So what are the current treatments for it?"

15:30 "So what's your device and how does it work? And how do you know that you're stimulating the Vagus nerve? "

19:30 "You guys are still in the prototyping phase and then you have to get FDA approval for this, what are the next steps for the company?"

21:15 "What are some I guess are your biggest challenges?"

23:30 "Would they have to get it as a prescription through a doctor? Would they be able to buy it on Amazon?"

24:15 "Is there anything that we didn't talk about that you wanted to mention?"

Nicolas Vachicouras is the cofounder of Neurosoft Bioelectronics which is focusing on utilizing a novel soft electrode material in neural implants. The company comes out of Switzerland and has partnerships with the Stephanie Lacour lab and the Wyss Center

1:45 "Do you want to talk a little bit about yourself and your work and Neurosoft?"

4:30 "What's the benefit of soft versus hard implant?"

7:00 "Is the foreign body response, something that happens in ECOG as well, does the body react poorly to that?"

9:45 "So your guys device also doesn't have MRI artifacts. What is that? How is that and why is it important?"

11:45 How was it spinning off a company in Switzerland?

14:15 "You've seen the Swiss side and the American or, Boston side, how would you compare and contrast those?"

17:15 "You guys have been very successful with competitions and these kinds of grants in everything like that. Do you want to talk a little bit about this as well?"

20:15 "What are some kind of next steps or plans for the future?"

22:00 "You're utilizing such a soft device. Do you want to talk about this a little bit?"

24:00 "You guys also have the spinal cord stimulators, do you want to describe this?"

28:15 "Is there anything that we didn't talk about that you wanted to mention?"

Anish Kaushal is an analyst at Amplitude VC which is looking at investing in neurotech companies. In this episode we talk about what they look for when investing into a company

1:30 "Do you want to introduce yourself a little bit? "

10:30 "How is venture capital different in med tech versus Silicon Valley?"

14:15 "So you guys do, would you say that you guys put more research upfront into investments vs Silicon Valley-style investors?"

16:30 "Due Diligence for, six months or a year, what are you doing during that time? What takes so long?"

21:30 "If somebody wants to be like the best candidate, what would be the best candidate for you?"

26:30 "You guys haven't invested anything yet, but what's on your radar?"

31:00 "And then how about for neurotechnology neuromodulation, neural implants?"

34:30 "What are some misconceptions or what are some things that people don't know about VCs and, med tech, VCs that they probably should know about, or maybe that they think is, but it's wrong?"

38:00 "Is there anything that we didn't talk about that you wanted to mention?"

Dr Silvestro Micera is a professor at École polytechnique fédérale de Lausanne (EPFL) in Switzerland focusing on developing neural interface implantations in patients.

In particular, the following research fields are currently investigated:

1. robotic systems for neurorehabilitation
2. experiments for the investigation of neural control of movement
3. development of neural interfaces with the central nervous system (CNS) and the peripheral nervous system (PNS).
4. development of hybrid neuro-prosthetic systems

1:15 "Do you want to explain your work?"

2:25 "You guys are very much into the compliant implants…do you wanna explain that a little bit?"

3:15 "You've worked in the central nervous system and the peripheral nervous system. Is there one that needs to be more compliant is the one that it needs to be softer?"

6:00 "One of your interests is a hybrid neuroprosthetic systems. Can you explain this? What is this?"

9:15 "one of the papers that you recently published actually was talking about enhancing the body with extra hands or fingers. Do you want to talk about this? And if this overloads the brain, that, do you want to talk about this?"

15:45 "do you have a favorite paper that you want to explain?"

21:45 "So that was your favorite paper. What about your, is that different than your most popular paper?"

23:00 "why did you get into this field?"

26:00 "What are your biggest challenges right now in your research?"

28:45 "And then you're doing this translational work. You're more that the process or the procedure and having that go into the clinic, how does that work?"

33:15 "I know the process a little bit in the U S is it different in Switzerland? This translational work?"

36:45 "Is there anything that we didn't talk about that you wanted to mention?"

Dr Warren Grill is a professor of biomedical engineering at duke university. He is the chief scientific officer of NDI medical LLC, Managing director of NDI Healthcare fund. He is the cofounder and chief scientific officer of Deep Brain innovations and Chief scientific advisor of SPR Theraputics.

His research interests are in neural engineering and neural prostheses including design and testing of electrodes and stimulation techniques, the electrical properties of tissues and cells, and computational neuroscience with applications in the restoration of bladder function, treatment of movement disorders with deep brain stimulation, and multi-joint limb movement. He has authored 250 peer-reviewed publications, and is an inventor on 54 issued patents.

2:15 "Do you want to talk a little bit about your work and how you've managed to publish 250 papers?"

4:45 "What do you think that's you're doing that there's a missing and what's the secret sauce?"

10:15 "How many people are in your lab?" 

12:00 "What is the thing that you believe that's maybe a little bit controversial in the field?"

15:15 "What are takeaways that you've had in your career about stimulation restoration and prosthetic control?"

24:00 Hear a bad joke that lands flat

24:30 "What is motivating you in this field? Why, especially neurotech?"

28:15 "How do you make sure applicable therapeutics and standards of practices transfer into the real world?"

32:15 "How do you balance those two things? Actually getting stuff done, actually getting things out to mass market without for lack of a better word, mental masturbation?"

 35:45 "What is the biggest challenge in your work?"

Eric Chang is a Neuroscientist and Assistant Professor at the Institutes of Bioelectronic Medicine and Molecular medicine at the Feinstein Institutes of medical research at Northwell Health. His areas of interests are Neuro-immunology, electrophysiology, microscopy and bioengineering. In today's episode, Eric talks to us about his work with the vagus nerve and approaches being used in his lab to understand signalling between the nervous system and immune system.

Top three takeaways:

1. We haven't got technology that can image individuals neurons connected to the vagus nerve but in the near future, the tools might evolve to do this.
2. Recording neural signals in different patients lets you see different types of variations across patients and informs how you design treatments based on that person's neurobiology.
3. "There are the traditional senses that are related to exteroception, like sight, sound, smell, touch, and taste. There's a plethora of as I mentioned, interoceptive signals as well that have to do with organ function."

[0:00] Ladan introduces the episode and the guest, Eric Chang

[1:50] Eric Chang introduces himself and his work. His lab is interested in finding the connection between the nervous system and immune system

[3:45] How is imaging different from electrophysiology and what are the advantages and disadvantages of both?

[6:10] "So I would say patch-clamp electrophysiology, which is patching a single cell with a glass pipette, is still the gold standard, but the tools are rapidly coming to the fore that are starting to replace that a little bit."

[11:20]  Eric talks about some of the challenges with imaging individual neurons connected to the vagus nerve, especially where there is a lot of movement.

[12:50]  While the technology is quite small now, it's not so small that it could quite fit into a necklace. Eric believes that somewhere in the next 5 - 10 years, something of the sort will be available.

[13:40] "Dr Tracey's work from two decades ago showed the discovery of something called the inflammatory reflex which is that If you electrically stimulate the vagus nerve under conditions of inflammation, let's say acute endotoxemia, then you can reduce levels of circulating pro-inflammatory cytokines"

[20:00] Eric discusses some of the tools used to tease apart different signals.

[23:05] Eric talks about some future breakthroughs he expects.

[27:00] "Yeah. So the nerve innervation exists for protection; it's for survival. We need to know when we're getting close to a fire"

[28:00] Eric talks about the importance of understanding pain.

[31:00] "There are the traditional senses that are related to exteroception, like sight, sound, smell, touch, and taste. There's a plethora of as I mentioned, interoceptive signals as well that have to do with organ function."

Marom Bikson is a Biomedical Engineer. He is a Professor at the City College of New York City and also the co-director of the Neural Engineering Group. Marom has been at the City College of New York for over 15 years. He has a B.Sc in Biomedical Engineering from John Hopkins University and a PhD from Case Western University Cleveland. He cofounded Soterix Medical. Marom's research group studies the effects of electricity on the human body and applies this knowledge toward the development of medical devices and electrical safety guidelines.

In today's episode, Marom talks about his work with Transcranial Direct Current Stimulation and how it works. He also talks about his work with NC Neuromodulation and Soterix Medical

Top three takeaways:

1. Transcranial means, through the cranium. And the thing that you're stimulating is targets inside the cortex. So you're trying to identify targets centrally that you think that you can activate. To lead to different therapeutic outcomes.
2. TDCS works by the application of direct electrical current to electrodes placed on the scalp.
3. "A lot of times when we think about TDCS, we think about changing the sensitivity. And then the question comes in with a sensitivity to what. Often TDCS is combined with other forms of therapy, like behavioural therapy, or physical therapy

[0:00] Ladan introduces the episode and the guest, Prof Marom Bikson

[1:50] Marom introduces himself and his work

[2:30] Marom discusses the wave of persistent COVID symptoms that are referred to as neuro COVID and talks about some of the work he and his colleagues are doing around it.

[4:50] Marom describes how Transcranial Direct Current Simulation work.
" transcranial means, through the cranium. And the thing that you're stimulating is targets inside the cortex. So you're trying to identify targets centrally that you think that you can activate. To lead to different therapeutic outcomes."

[6:00] Marom discusses papers documenting the use of TDCS in different therapeutic areas such as depression and pain.

[7:45]  Currently, there is no FDA clearance for TDCS in the US so most of the work now happens in clinical trials. 

[10:10] TDCS works by the application of direct electrical current to electrodes placed on the scalp.

[13:40] "A lot of times when we think about TDCS, we think about changing the sensitivity. And then the question comes in with a sensitivity to what. Often TDCS is combined with other forms of therapy, like behavioural therapy, or physical therapy."

[16:20] Marom talks specifically about his research and some of his breakthroughs.

[20:50] Marom talks about his company, Soterix medical; the background for starting the company and what kind of problems they are solving

[27:40] Marom discusses NYC Neuromodulation which he co-founded.

"NYC neuromodulation has now run. I think about five times the last time was an online version. The two times before that we worked with other organizations, the North American neuromodulation society was partnered for one and neuromodulation of science was partnered for another."

[33:50] So what are some Big pieces of advice that you would say to other neural engineers?

" If you're loving what you're doing, then that probably means you're on the right path."