Neural Implant podcast - the people behind Brain-Machine Interface revolutions

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 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. 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. "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. 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. 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 of the Neural Implant Podcast, host Dr. Ladan Jiracek speaks with Dr. Christian Iorio-Morin, functional neurosurgeon and professor at the Université de Sherbrooke, about the evolving landscape of neurosurgery—from treating movement disorders and chronic pain to pushing the boundaries of paralysis recovery. Christian shares insights from his clinical work using gamma knife surgery, neuromodulation, and microvascular techniques, as well as his leadership on the RE-MOVE project, a large-scale initiative aiming to restore movement by reconnecting the brain and spinal cord through implantable technology. The conversation explores how modern neurosurgery is shifting from treating symptoms to rebuilding lost function, why many "paralyzed" systems still retain underlying capability, and how combining neuroscience, engineering, and patient-centered design could unlock a new generation of therapies for stroke, spinal cord injury, and beyond. Top 3 Takeaways: Most "brain stimulation" treatments actually work by shutting circuits down, not activating them. Despite the name, therapies like deep brain stimulation, gamma knife, and ablation all achieve similar results by disrupting pathological neural circuits—essentially "jamming" the signal rather than enhancing it. Innovation in neurotech is bottlenecked by lack of access to device software and hardware. Researchers often can't test new ideas because commercial devices are locked down—forcing unnecessary duplication of effort and slowing progress across the field. "Neuro hype" is a real problem—and unrealistic expectations can harm patients. Many patients overestimate what neurotechnology can do today. Setting honest expectations is critical, as current treatments improve function but rarely fully restore it. 0:55 – Do you want to introduce yourself better than I just did? 2:40 – What is Gamma Knife and how does it work? 5:20 – How does Gamma Knife compare to deep brain stimulation? 10:45 – Why do patients choose lesions over implants? 15:05 – When is neuromodulation preferred over lesion-based treatments? 20:30 – What are neural engineers getting wrong today? 21:00 – Why is it so hard to test new ideas in neuromodulation? 28:50 – Should neurostimulators be more open and accessible? 33:20 – How competition is driving innovation in neurotech 35:00 – The problem of "neuro hype" and unrealistic expectations

In this episode of the Neural Implant Podcast, host Dr. Ladan Jiracek sits down with Omari Bouknight, CEO of Resonant Link Medical, to explore how advances in wireless power transfer are reshaping the future of implantable medical devices. Omari shares how traditional power limitations have historically constrained device design—and how Resonant Link Medical's technology is turning power into an enabler, allowing for smaller, smarter, and longer-lasting implants. The conversation dives into real-world applications across neurotech and beyond, including how faster, more efficient wireless charging could unlock advanced closed-loop therapies, high-data-rate neural systems, and more fully implantable devices Top 3 Takeaways: Resonant Link Medical's key breakthrough is highly efficient and flexible wireless power: their multi-layer self-resonant structure (MSRS) coil technology enables high-efficiency wireless energy transfer with minimal heat generation, and innovations in power electronics and data transfer support highly adaptive systems with high tolerance to misalignment. This solves two major historical barriers to implantable wireless charging, allowing patients to quickly and easily recharge devices during normal daily activity. Wireless power works deeper in the body and tolerates real-world movement: Resonant Link Medical's system can deliver power at depths up to ~6 cm (and potentially more) while allowing several centimeters of lateral misalignment and angular tilt. This enables reliable charging even with normal body motion and imperfect alignment at up to 15 W of power. Wireless power is becoming a foundational enabler across implantable devices, ranging from brain-computer-interfaces (BCIs) and spinal cord stimulators to peripheral nerve, sleep apnea, and even cardiac and orthopedic implants. Resonant Link Medical's platform technology is helping unlock closed-loop therapies, new targets, and smarter devices—and the field of active implantables is still only at the very beginning of its potential. 0:45 Do you want to introduce yourself better than I just did? 1:30 Tell us a bit more about the technology 5:00 What does the form factor look like? 7:15 What are the misalignment tolerances? 9:15 Are you guys device agnostic and just want to power people's neurotech devices? 10:15 What are the dimensions? 12:45 What are some of the areas you guys have worked in? 18:00 What's the history of the company? 21:30 What's in store in the future for these devices?  

In this episode of the Neural Implant Podcast, host Dr. Ladan Jiracek sits down with Francesco Petrini, co-founder and CEO of SensArs, to discuss how intraneural stimulation could help restore sensation in patients with diabetic neuropathy. Francesco explains how loss of feeling in the feet can lead to unnoticed injuries, chronic wounds, and even amputations - and why rebuilding sensory feedback could dramatically improve quality of life. The conversation explores SensArs' approach to neuromodulation and what it takes to translate sensory neuroprosthetics into real-world clinical impact. Top 3 Takeaways: In diabetic neuropathy, the biggest danger is invisible damage: when patients lose sensation in their feet, they may not notice external threats like hot sand or a pebble in their shoe, and they also lose the natural sensory feedback that helps regulate balanced walking - leading to abnormal pressure, skin breakdown, ulcers, and ultimately a higher risk of amputation. Diabetic neuropathy is one of the most expensive health burdens in the US: its complications cost the healthcare system roughly $80 billion per year, making it comparable to cancer and among the top drivers of medical spending - yet sensory restoration still isn't available, highlighting the urgent need for better solutions. Restored sensation can translate into real functional gains: in prior studies with amputees, SensArs showed that patients not only felt sensory feedback, but actually used it - walking ~30% faster (including on uneven ground and stairs), reducing falls by ~80%, and even eliminating nerve-related pain. With those results in hand, most of the upgraded system is clinic-ready, with the stimulator being the main remaining component needing additional testing. 1:00 Do you want to introduce yourself better than I just did? 5:00 So the ulcer occurs as a result of walking incorrectly? 6:45 What caused you to go after this indication? 10:30 Sponsorship by blackswan-ip  11:00 Can you describe you technology and what is involved in this implantation and product? 14:00 Are the shoes more attractive than current shoes? And could this be done via just an app? 16:45 What's the advantage of having the implant as well as the electronic insole? 18:30 And the notification needs to be timely, damage can happen within a few minutes? 20:00 What stage are you and your company at? 22:15 How did you go from being a successful researcher to going into entrepreneurship? 23:45 What was the timeline of your progress? 26:15 Is this intraneural stimulation something that would be useful for other indications as well? 27:45 Does diabetic neuropathy mean that the nerve you implant into eventually will die as well? 28:45 Is there anything that we didn't talk about that you wanted to mention?

In this episode of the Neural Implant Podcast, host Dr. Ladan Jiracek sits down with Dr. Ignacio Sáez, neuroscientist at the Icahn School of Medicine at Mount Sinai, whose lab uses intracranial brain recordings to study the biology of human cognition. Ignacio shares how cutting-edge neurotechnology like iEEG can reveal the neural dynamics behind decision-making, risk, memory, and brain states - and how those insights could unlock more targeted neuromodulation therapies for psychiatric disorders such as depression and anxiety.  Top 3 Takeaways:  Epilepsy patients undergoing seizure monitoring often have 100-200 electrodes implanted in their brains and may spend days in the hospital waiting for a seizure. Ignacio's lab uses this rare window to record high-quality human neural activity while patients complete cognitive tasks and computer-based games - giving researchers an unparalleled way to study human brain function in real time. Working with Precision Neuroscience has been transformative because their Layer 7 device offers a completely different view of brain activity than traditional epilepsy electrodes. Instead of ~200 electrodes spread across multiple brain regions, Precision's flexible micro-ECoG array packs 1024 non-penetrating electrodes into about 1 cm², enabling ultra-high-density recordings from a single, discrete cortical area without damaging tissue - helping researchers zoom in on local circuits and uncover new insights into brain function and treatment pathways. One major advantage of doing cognitive neuroscience in humans is that researchers can directly ask subjects what they were thinking, feeling, or paying attention to during a task - giving "ground truth" insight that animal studies can only infer indirectly from behavior. 1:00 Do you want to introduce yourself better than I just did? 9:30 How did you make that transition from animal work to human work? 15:15 Sponsorship by blackswan-ip  16:15 Do you see a difference between devices with many electrodes vs those with fewer? 18:45 What's it like working with Precision Neuroscience and how do their higher channel counts help? 24:00 What is your workflow and what is the source of your funding? Usually from companies? 26:45 How many trials can you do at once? 29:15 What are some challenges in this work? 31:15 How many other people are doing this kind of research? 34:15 What changes to new designs or devices do you foresee as a result of this work? 41:45 Is there anything that we didn't talk about that you wanted to mention?

In this solo episode of the Neural Implant Podcast, host Dr. Ladan Jiracek shares the story behind finally completing his PhD at the University of Florida - from the highs of passing his dissertation defense to the long, frustrating, and deeply technical journey of developing liquid crystal polymer (LCP)-based neural implants. I break down why LCP is so promising for long-term implantable devices, how delamination and bonding challenges became the core focus of his dissertation, and what it took to fabricate ultra-thin polymer electrodes approaching "biological invisibility." I also reflects on the unpredictable nature of the PhD timeline, how the podcast helped shape his network, and what's next as he continues in the lab as a postdoc while building IntimaStim, my startup focused on restoring sexual function after spinal cord injury.

In this episode, Paul Goode (Glucotrack) dives into the next wave of continuous glucose monitoring: an active, fully implantable CGM designed to deliver long-term, pacemaker-style reliability without external wearables. We discuss first-in-human progress, why implantables may change diabetes care at home, and a fascinating neural angle—how similar chemistry and form factors could be adapted to epidural glucose sensing and even paired with neural recording electrodes to capture metabolic and neural data together. If you care about closed-loop systems, chronic implants, or bridging bioelectrochemistry with neurotech, this one's for you.   Top 3 Takeaways: Epidural glucose sensing works long-term: Initial short animal tests showed continuous glucose measurement in the epidural space, and a follow-up multi-month study delivered phenomenal, stable results. Epidural placement matches CGM performance: The sensor sits on top of the dura mater in the epidural space (effectively an interstitial environment) and, in studies run alongside a conventional subcutaneous CGM, showed comparable timing and responsiveness. Since the brain runs on glucose, this is surprising but logical.  Seamless SCS integration is feasible: The epidural glucose sensor uses a simple potentiostat and three-electrode setup, adding minimal electronics to existing spinal cord stimulator platforms. The team aims to generate first-in-human data to catalyze partnerships with SCS companies. 1:15 Do you want to introduce yourself better than I just did? 2:15 Why was a glucose sensor company invited to come on the Neural Implant Podcast? 7:15 How many electrodes on a device would need to be used in order to measure glucose in the epidural space? 8:45 How do your glucose measurements compare with Continuous Glucose Monitors? 12:30 What's the company's next step? 16:00 Is there anything you would want of the Neural Implant community?  

In this episode of the Neural Implant Podcast, I speak with Fabio Boi, Co-Founder and CSO of Corticale, an Italian neurotech company that is redefining the landscape of brain-computer interfaces. Corticale is pioneering a new generation of minimally invasive, CMOS-based neural implants that can record from thousands of neurons simultaneously—introducing their flagship technology, SiNAPS. Fabio walks us through how SiNAPS achieves single-cell resolution recordings via its 1024-electrode array, enabling high-fidelity access to both action potentials and local field potentials deep within cortical tissue. We also explore the significance of modular probe design, ultra high-density sensors, and the potential clinical and research applications of such a breakthrough platform. 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: Corticale's SiNAPS probes miniaturize electronics directly beneath each electrode, enabling every channel to independently record signals. Unlike traditional systems that require pre-selection or external r eadout bottlenecks, this design supports simultaneous, high-resolution recording across the entire array. Moving from hundreds to thousands of recording channels exposes neural complexity that was previously missed. For brain-computer interfaces, this data richness significantly improves decoding accuracy and performance. Startups should prioritize building the right team even before finalizing the technology. As Fabio reflects, having a team with the right expertise early on can help avoid costly mistakes, save time, and steer the company in the right direction—something he wishes he had done from the beginning. 0:45 Do you want to introduce yourself better than I just did? 3:00 What are some of the features of your technology? 5:30 What kind of cutting edge fabrication are you using? 6:30 What application do you see this being useful for? 10:15 Sponsorship by blackswan-ip  10:45 So who are you main customers now? 12:45 What are the upper limits of this technology? 16:00 So you guys are working only on the hardware side of things? 16:45 What kind of data processing do you need for this? 18:45 What do the next 5 years look like for you? 20:15 What kind of patient population would you be targeting? 21:00 What is it like to be based in Italy? 24:00 Is there anything that we didn't talk about that you wanted to mention?  

In this episode of the Neural Implant Podcast, we sit down with Ben Woodington, co-founder of Coherence Bio, a groundbreaking medical technology company pioneering a new frontier in cancer treatment. By integrating neurotechnology, neurobiology, and machine learning, Coherence is building a platform that doesn't just fight cancer—it manages it in real time. Ben shares how Coherence is moving beyond the traditional "cut, burn, poison" model of oncology, and instead focusing on precision neuromodulation to monitor and control cancer progression—offering hope for 24/7 adaptive treatment with fewer side effects and better quality of life. Their platform, SOMA, is the first in a suite of technologies aimed at achieving this ambitious goal. We also explore the emerging field of cancer neuroscience, the role of BCIs and digital neural interfaces in oncology, and how Coherence's research is predicting brain metastasis, decoding neural signatures of gliomas, and applying electrotherapy to fight tumors. 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: Coherence is targeting glioblastoma as its first application due to its urgent unmet clinical need—patients face a median survival of just 14 months, and the standard of care hasn't evolved in over two decades. Despite the broader applicability of their technology across brain cancers, focusing on this aggressive, treatment-resistant form gives them a high-impact entry point to demonstrate the value of real-time, adaptive neuromodulation. Coherence is exploring two groundbreaking mechanisms for treating brain cancer: directly stimulating cancer cells to inhibit division, and disrupting the neural-cancer feedback loop that drives tumor growth. Inspired by work from Stanford's Michelle Monje lab, they aim to block the synaptic connections between neurons and tumor cells—cutting off the electrical signals and neurotrophic support that fuel cancer proliferation. Implants will be placed during patients' scheduled tumor resection surgeries, minimizing additional intervention. Rather than performing separate procedures, the team collaborates with surgeons during planned tumor debulking to implant devices, enabling safety and neural recording studies without altering standard care pathways. 0:45 Do you want to introduce yourself better than I just did? 2:00 Is that what OptoBio was doing as well? 3:15 What is the mechanism of action for curing cancer? 6:00 How are you treating the cancer? 8:15 Is this a localized treatment around the implanted area only? 17:15 Sponsorship by blackswan-ip  11:15 How are you measuring the signal of the cancer? 12:00 What level of development are you guys at? 14:00 How are clinical trials approval different for terminal patients? 15:45 How do you deal with the sense of urgency to get this technology out? 18:30 What would you want to see in the Neural Implant Community? 23:15 Is there anything we didn't talk about that you wanted to mention?

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? 

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 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?

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?

Suraj Mudichintala is a Senior Associate at Action Potential Capital which is GSK's bioelectronic medicine venture fund. Top 3 Takeaways: "Our fund is different in that we invest actually directly off of GSK's balance sheet. So we're what's called an evergreen fund where we don't actually have a fund size" "The way that I think about it is that a VC is really paid to allocate capital but really is really paid to think. You really have to think about what is the next space or the next technology that could disrupt a space? And because of that, it's a much you often have to take a much more longitudinal view. And it takes a lot of patience and tracking a space oftentimes for years" "When you reach out to a VC having a pitch, first of all, sending a non-confidential pitch deck is mandatory, I think. And that deck is essentially where we're making the first decision as to whether or not to do a call with you" 0:45 Do you want to introduce yourself better than I just did? 1:15 "Do you wanna talk about Action Potential, what it is, who it was formed by, and the investment thesis?" 2:30 Do you want to talk about the expansion of the AP investment thesis? 4:30 What does traditional Venture Capital look like and how is it different in that you are funded by GSK? 6:15 What do the positions within a VC firm look like? 7:45 How has it been for you going from Analyst to Associate? 8:45 What does your due diligence look like? 11:45 "A lot of VCs have a target size range, be it seed or angel or, maybe larger institutional stuff. But it sounds like you guys don't really have that?" 12:45 "How did you get into this space?" 14:45 "So how does consulting compare to the VC life?" 18:45 "What would you suggest is the best way to get your attention?" 24:00 What are some tips and tricks to reaching out to you? 27:00 What was the worst pitch deck you ever saw? 28:30 " Is there anything that we didn't talk about that you wanted to mention?"  

Balint Varkuti is the CEO of CereGate which unlocks new capabilities for existing neuromodulation technologies using software. Top 3 Takeaways: "the brain is naturally wired for pattern perception for learning, and that's really what we do. We send signals that the brain very quickly can pick up." "You do not need to exclusively be focused mentally, consciously on interpreting these signals. Rather it becomes second nature. Our favourite analogy is saying it is like braille for the brain." "With hardware, you sometimes have simply the disadvantage that you are married to the time point when you started. So if you started a long time ago, you started with that technology and you have a whole regulatory documentation that's building on that. So fundamentally pivoting in hardware down the road almost becomes impossible." 0:45 Do you want to introduce yourself? 3:00 What is special about the software that hasn't already been done? 11:30 The brain is plastic and the software is changing so how does it work with these two systems fighting? 13:30 How can this approach be used to treat Parkinson symptoms such as Freezing of Gait ?" 14:15 Can you read braille? 15:30 "How fast does a patient learn to use this?" 19:00 " How can a company work with you?" 21:15 You guys have been in stealth mode for 4 years, why did it take 4 years and do you have any success stories so far? 23:45 "Do you wanna talk about the regulatory pathway and how it was how to do a software versus a hardware solution?" 27:00 How did your background in behavioral sciences shape your outlook to the company? 30:15 You didn't mention coding in your background, can you talk about starting a software company without much coding experience? 31:30 You have 25 people involved in the company but doesn't seem that you have raised much money, why such a big team? 35:15 "What does the next four years look like? What's on your horizon?" 37:00 "Is there anything that we didn't talk about that you wanted to mention?"

Kevin Tracey returns to the podcast to give an update about his work at the Feinstein Institutes and the work at SetPoint Medical. Top 3 Takeaways: "Two years we discovered that a drug called Famotidine, which is sold as a generic drug Pepcid AC is actually a pharmacological or a drug-based vagus nerve stimulator. And we proved first in mice that famotidine placed directly in very small amounts placed directly in the brains of mice activates the vagus nerve. And this in turn turned off cytokine storm, which of course is a big problem in Covid 19" "A company that I've co-founded, Setpoint Medical, is currently deep into clinical trials in the United States called ResetRA, which is on clinical trials.gov or on the SetPoint website for rheumatoid arthritis patients. And that trial is enrolling many patients up to, I think 250 patients will be studied according to the websites and we're hoping that goes very well. And we're hoping, I'm hoping that leads to FDA approval for vagus nerve stimulation in the US in the coming days or coming in the coming months" "I think we're very close now to vagus nerve stimulation becoming a reality for millions of patients. And I, I hope, and I see a time when patients have the. Of  choosing vagus nerve stimulation as a simple, safe therapy instead of dangerous, expensive drugs with black box warnings that are minimally effective." 0;30 "Do you wanna introduce yourself and talk about some of your work, especially as neuromodulation pertains to the immune system?" 2:45 "So the last time when we talked it was 2020. So pandemic, everything was upside down. But then you were telling me before we started recording that it was also especially busy for you at that time. So what were you up to around then?" 6:00 What were the quantitative takeaways of the Famotidine Covid trials? 8:15 "Why didn't it become standard practice?" 11:00 "You're saying the famotidine has this effect on the vagus nerve. Does this mean we no longer need vagus nerve stimulators? Can we just take Pepcid, AC?" 15:00 Do you want to talk about the Bioelectronic Medicine Summit? 17:30 What were some of the highlights of the Summit?  19:30 "You mentioned some interesting results. Is that something you can share now or is that something that we should be on the lookout for?" 21:30 "You were also featured recently in the Wall Street Journal and New York Times, what was that like and what were the articles about?" 23:15 "So what's exciting you now for 2023 and what's on the horizon for you for the next few years?" 27:15 "Is there anything that we didn't talk about that you wanted to mention?"

Israel Gasperin is the founder and CEO of Zentrela which uses wearable EEG caps to quantitatively measure cannabis experiences. Top 3 Takeaways: "The reason why the government funded us was to use this for safety and law enforcement" "The combination of features that AI is finding is something that we haven't really focused on studying and trying to understand. It's a black box today that, is accurately and objectively characterizing the  psychoactive effects, but we don't exactly know what they mean." "Based on this neuroscience-driven research proving the onset time of the beverage, within two weeks [the company] increased their sales by 7% and they achieved record volume cells after. So what we did, or they did, was to educate the retailers to speak about their product based on this scientific publication, rather than, providing their subjective opinion" 0:45 Do you want to describe yourself better than I just did? 1:00 "We're talking about marijuana, we're talking about getting high. What are you measuring or what's the reasoning behind this?" 11:00 " You're saying that you can tell if people are high or not. What kind of confidence do you have and, what shows up in high people's brains?" 14:15 Do you want to talk about one of your success stories working with a company?  22:45 "How many people have you had come through your labs and run through your system?" 24:00 "Of the 20,000 sessions, how many are yours?" 27:45 "You've been working on this for six years. What do the next six years look like?" 32:15 "What are some challenges?" 35:45 "Is there anything that we didn't cover that you wanted to mention?" https://www.linkedin.com/in/israelgasperin/?locale=en_US 

Colin Kealey is the President and CEO of NeuroSigma which is commercializing the Monarch eTNS System, the first non-drug treatment for pediatric ADHD cleared by the FDA.  Top 3 Takeaways: NeuroSigma is commercializing the Monarch eTNS system, a wearable medical device that stimulates the trigeminal nerve on the forehead, as a treatment for neurologic and neuropsychiatric indications. The Monarch eTNS System is FDA cleared as a treatment for pediatric ADHD, ages 7 – 12. Clinical trials in this population show a response rate of 50% with a only mild side effects observed in clinical trials to date. NeuroSigma is also developing its eTNS technology for other indications including epilepsy and depression and is currently running two large double-blind randomized controlled trials in ADHD to expand the label into adolescents, and for using the device as adjunctive therapy.   0:45 "Do you want to introduce yourself better than I just did?"  7:15 What is the efficacy of your device? 8:45 "What are some typical side effects of pharmaceutical ADHD treatments and what are some typical side effects of your guys' treatment?" 16:45 That was the pharmaceutical side effects, how about the neurostimulator side effects? 20:00 How does it work sleeping with a wired system? 21:45 "Were you guys able to cross-reference with any other sleep metrics to see if the quality of sleep diminished or maybe even increased?" 24:30 What's the protocol for using this device? 26:30 Could adults use this also? 28:30 Will college students use this as a study aid? 29:30 "What does your funding look like?" 35:15 How will you prevent Chinese knockoffs? 38:30 " Is there anything that we didn't talk about that you wanted to mention?"  

Craig Mermel is the President and Chief Product Officer at Precision Neuroscience which is a company looking to commercialize Brain-Computer Interfaces using a minimally implantation method and a soft electrode device. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services here*** Top 3 Takeaways "The combination of both the nature of our thin film and the surgical innovations that we bring enables us to bring cortical surface neurotechnology to patients in a minimally invasive fashion." "Having 10 times the amount of money at an early stage before you actually solve some of the key problems can be a problem because it pushes off some of the hard questions you have to ask yourself." "We're thinking ahead to the future where you have tens of thousands, hundreds of thousands, or millions of interfaces. The amount of damage you do will become a limiting factor at some point." 0:45 Do you want to introduce yourself better than I just did? 1:30 Why did you leave Apple and Google? 2:30 What is Precision and why is it special? 6:00 What's the funding look like? 8:00 "Why hasn't this been done before?" 10:00 Are you thinking about licensing out the technology? 11:15 Iris Biomedical ad sponsorship 12:00 What's your role now in Precision?"  12:45 "What are some of your biggest challenges?" 15:30 You guys raised $12M, why specifically this number? 19:00 "What are some, best practices or traps to avoid?" 21:45 Let's do a deeper dive into your work at Google and Apple  27:30 How would you compare working at Google and Apple vs being in a startup? 29:15 "Is there anything that we didn't talk about that you wanted to mention?"  

Lothar Krinke is the CEO and Board Member of Newronika which is an adaptive Deep Brain Stimulator company looking to improve patient outcomes in things like Parkinson's and Essential Tremor. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services here*** Top 3 Takeaways: "the one thing we do need to address is really the cost. The cost driver of Deep Brain Stimulation isn't the manufacturing of the system. Now, that's not cheap either it's certainly less than $10,000. How expensive is brain surgery, particularly functional brain surgery? How expensive is it to have all the pre-operation preparation? So I think the field needs to think about how we can lower the cost of Deep Brain Stimulation to make it available to not hundreds of thousands of patients, but literally millions of patients." "I don't think AI or even machine learning has been sufficiently applied in our space. People do it and they talk about it, but if you look at other fields, even EEG, use of AI or machine learning are much more penetrated." "In my mind it is almost unconscionable that only 15% of patients that could benefit from Parkinsons, from DBS do. So somehow we need to have a battle cry. We need to have the responsibility to make this therapy available to more people. And the way to do that is less invasive more automation and lower cost" 0:45 Do you want to introduce yourself better than I just did? 2:15 "Why is Deep Brain Simulation so exciting for you?" 3:15 "Can explain what Deep Brain Stimulation is and what it's a treatment for?" 5:30 "How did you get into the field?" 6:30 Iris Biomedical ad sponsorship 7:15 You thought earlier that DBS was too invasive but now changed your mind, why? 8:15 What are the biggest impediments to DBS? 12:15 Why is the Newronika DBS better than the alternatives? 14:30 Why is adaptive DBS better? 16:30 "What are some of the biggest challenges right now at Newronika?" 20:30 You are in Minneapolis, West Virginia, and Milan, how are you able to travel so much? 21:30 "Why aren't you in Gainesville? I was surprised how big the DBS field is here." 22:15 "For people starting out in the field, do you have any advice?" 25:30 " What's a big mistake or wrong direction that you see researchers or people on your field going down?" 27:45 "Could you explain the beta and gamma waves?" 32:45 "Is there anything that we didn't talk about that you wanted to mention?"

Damiano Giuseppe Barone is a neurosurgery clinical lecturer at the University of Cambridge and fellow at The Walton Centre in Liverpool, UK. He is interested in tackling basic and translational challenges for the development of the next generation of neural bioelectronics. ***This podcast is sponsored by Ripple Neuro, check out their Neuroscience Research Tools here*** Top 3 Takeaways: "My favorite procedure is the procedure that works and you see the patient after that is is a changed patient."  "You come out from medical school like age 23 or 24. Then you get to a general medical program which in the United Kingdom lasts 2 years in and then you get to the residency, which is 8 years. And then 10 years after you are age 34 practicing the neurosurgeon. I personally took what is called an 'out of programme for research/. So basically I halted my neurosurgery residency. I stepped out and I stepped in a PhD program while still covering what is called the on-call rota, which is basically doing emergency work in neurosurgery just to keep my clinical skills going." This added a few more years of training to the list. "Quality of life procedures, to be offered to the patients, will have to have a 70 to 80% improvement to justify the risks the patient will have to go through." 0:45 Do you want to introduce yourself better than I just did? 2:45 You spent 20 years in training for this, did you know this at the outset? 4:00  "What's it like to get only a few hours of sleep for years?" 5:00 Why did you choose to go the PhD route as well? 7:45 What's it like to be digging around in the body? 9:45 Sponsorship by Ripple Neuro 10:00 "What's your favorite procedures and what's your least favorite procedures?" 12:15 "What percentage of patients see improvements?" 14:30 "What are some, risks other than it not working, what are maybe some damage or maybe even death is that a possibility?" 16:45 "It's much more dangerous to have, a large device versus a small device. Is that kinda what you've seen?" 18:45 "Have you been involved in electrode design or device design?" 19:45 "What are you working on now?" 25:00 "What are the next steps?" 28:00 "What would you recommend or what kind of advice do you have for people considering this?"

Jon Sakai is the Head of Commercialization at Cionic, a wearable neurostimulator sleeve for those with neuromuscular disease ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services here*** Top 3 Takeaways: "There isn't any individualized training that needs to happen. What needs to happen is the identification of which muscle groups need support and have those turned on and programmed in intensity appropriately." "We were able to improve door sub selection and inversion in more than 90% of our participants." "There's nothing like getting an appreciation for a problem like the acuity of a problem when you just watch someone for five minutes struggle with something that's probably unimaginable if it's a condition that you're not familiar with." 0:45 "Do you want to introduce yourself better than I just did?" 2:45 "There are algorithms that go behind it and it can actually predict how you're walking. How does that work?" 3:45 "Is there a learning process for the algorithms?" 5:00 "Do you guys use hydrogels as well? And how do you have gels inside of your leggings?" 5:45 Iris Biomedical ad sponsorship 6:30 "What kind of improvement is there?" 8:30 How can your algorithm predict the end of a walking cycle before it has started? 9:15 What was it like getting FDA approval? 9:45 What are the next steps for the company after raising your next round of funding? 10:30 How is this going to be sold? In clinics, prescriptions, or normal retail? 11:45 What is Head of Commercialization and how does one get that role? 14:45 "You guys have been around for four years. What do the next four years look like?" 16:30 "What are some big challenges that are facing?" 17:30 "If you had unlimited funding, what would you do?" 18:30 What is some career advice you have? 22:45 " Is there anything that we didn't talk about that you wanted to mention?"

Hannah Claridge is the Head of Neurotechnology at TTP which is a consultancy that helps neurotech companies create the next generation of medical devices. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services here*** Top 3 Takeaways: "I think consulting is really fantastic for the variety that it offers you. Not just in terms of seeing problems, but also working with different types of companies, different types of technologies, and having different day-to-day activities as well" "There have been cases where we've worked with very small companies where the company is composed of two or three founders whose sole role is the concept of the idea and the thinking behind what's the business case, and then gathering in the funding and passing that funding through for us to carry out the product development work. Now that's pretty unusual in most cases." "You need to be able to balance the efficacy of treatment with the side effects that are usually created. And if you go too far in one direction or the other, then that treatment stops being helpful. So if you stimulate too strongly, and the effect might be really effective but if the side effects are too strong, then patients aren't going to tolerate that." 0:45 Do you want to introduce yourself better than I just did? 1:45 "Let's talk about clinical translation, what does that entail?" 4:45 Iris Biomedical ad sponsorship 5:45 "What's a typical contract length and what does it look like from beginning to end?" 9:00 "It really sounds like you guys do everything. You could just take an idea and then bring it almost all the way to market" 10:15 "Do you wanna share the neurotech projects you've worked on?" 11:15 "What's a common problem that you see?" 17:15 "How does a company recover, like from having so much help to not having any help? Is that typical too?" 19:45 "What does your day-to-day look like? What are you usually doing?" 22:30 What's a typical pathway into the career of consulting? 25:15 "If you had unlimited funding or if a company had unlimited funding, what would you do?" 28:00 "Is there anything that we didn't talk about that you wanted to mention?"

Lindsey Jardine is a clinical project manager at Boston Scientific which had acquired Farapulse, a cardiac ablation medical device company she was working in. She runs clinical trials for medtech companies and had done so for neurotech companies as well. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services here*** Top 3 Takeaways: "One of the most difficult things that I've found while you're actually running the study, is making sure those devices are getting to the sites, which is depending on where your manufacturer is" Hiring a Contract Research Organization (CRO) or hiring clinical trial specialists in-house depends on what the plan for the company is, whether it will be acquired or do an IPO "My biggest problem with startups is wanting to do too much. Because if you're trying to develop eight things at once, you're not gonna get there and you're gonna run outta money. And that's how I see a lot of startups fail" 0:45 Do you want to introduce yourself better than I just did? 1:15 "What is a clinical trial?" 2:45 "How do medical devices maybe neurotechnology, compare to pharmaceuticals?" 4:15 "What's a timeline?" 6:00 "Where does the time get used up and then where does the money get used up?" 8:45 Iris Biomedical ad sponsorship 9:15 "Let's talk about budgets and how they vary, why they vary" 11:30 "What does your day-to-day look like?" 17:45 "How did you get into it?"  21:45 What would be the formal path to get into clinical trials? 26:15 "What's a common mistake for startups?" 29:30 "Do the big guys have a speed advantage?" 31:00 "Is there anything that we didn't talk about that, that you wanted to mention?"

Dan Brounstein is Chief Strategy Officer at Saluda Medical where he is using his 15 years of Spinal Chord Stimulator experience to help deliver closed-loop pain relief directly to the spinal cord. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services here*** Top 3 Takeaways:  "We're stimulating with milliamps and we're trying to measure in microvolts, and we always use the analogy trying to listen to a pin drop next to a shotgun shot" "There's a lot of literature on loss of efficacy? It's just a therapy issue. When you deliver open-loop therapies blind across a neural target, you're ultimately going to create, over-stimulation in a lot of times under stimulation. On top of that, over time things change" "Patients come in between four and five times a year on average in perpetuity with open loop systems" 0:45 " Do you want to introduce yourself and the company better than I just did?" 6:00 "Your guys' device reprograms on its own? And then what signals does it take in and how does it change the stimulation patterns based on that?" 9:00 Iris Biomedical ad sponsorship 9:45 "What is your input and output for your guys' device?" 11:45 "In February of 2023, you guys got FDA approval for this. Do you wanna talk a little bit about this?" 14:15 "Is it like 5% better than open loop or is that something that's gonna be coming out published later?" 17:00 "Is there another indication?" 18:15 "The last I guess seven years for you has been very exciting. Is there anything on the horizon for the next seven years?" 20:15 "You guys have 300 people and have raised 200 million. What's it like working in such a big company" 22:45 "Is it getting too big for you?" 23:45 "What advice do you have for people in your situation?" 26:00 "Is there anything that we didn't talk about that you wanted to mention?"

Dr Angelique Johnson is the founder and CEO of MEMStim which is a leading global medical device outsource manufacturer (MDO) serving the neurostimulation market, based in Louisville, KY. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services here*** Top 3 Takeaways: "Our true competitors are actually not microfab but actually hand assembly, manual assembly" "I'm an accidental entrepreneur- the more I pitched, the more I thought about the business idea, the more I talked to actual customers the more I realized like, Hey, there's actually a need and we actually have a pretty good revenue model for meeting that need." "Kentucky actually matches investment and grant dollars depending on where your grants come from." 0:45 "Do you wanna introduce yourself better than I did?" 2:45 How did you make 3D cochlear device out of 2D microfabrication? 4:40 "Tell me about the founding of MEMStim" 8:00 Are you guys moving away from MEMS and towards 3D printing only? 9:00 Is the future 3D printed soft materials? 10:15 Iris Biomedical ad sponsorship 11:00 "Who are your customers right now?" 13:45 "What does the design process look like?" 16:15 "Have you helped companies get through ISO certifications and FDA approvals?" 18:30 "Do you guys do the implantable pulse generator or do you just do the electrodes?" 21:00 "Are you guys also prepared to ramp that up into actual production?" 22:45 "Do you have any advice for how you've survived for so long? 29:45 "What are the last five years that looked like and what are the next five years look like?" 31:00 "You're based in Kentucky, Louisville. Is there any reason for that?" 33:15 "Is there anything that we didn't talk about that you wanted to mention?"  

Dr John Seymour is an Associate Professor at UT Health in Neurosurgery and at Rice University where his lab works on electrophysiology studies, biophysics modeling, and applying machine learning models to decoding of neural activity. A major project in our lab is focused on developing a long-term brain-machine interface for the treatment of aphasia or locked-in syndrome. ***This podcast is sponsored by Ripple Neuro, check out their Neuroscience Research Tools here*** Top 3 Takeaways: "Your job as the engineer is to create a high resolution map of a crowd's vocalization during some live event, the rules are, you only get the place, say 10 or 20 devices throughout the stadium but only on these devices. At some point you realize more and more microphones on these poles are going to generate redundant information and they won't help us in our challenge to map the vocalization of this massive stadium. People have a very good intuition for sounds and we all understand sound is directional. Neural signals act the same way." "A rough rule of thumb is if the substrate diameter is on the order of magnitude of the source size, then there is good directionality in that situation." One day neural devices will be based on the patient's anatomy and will be printed on-demand to match the patient 0:45 "Do you want to introduce yourself better than I just did?" 2:45 "Geographically, how close are Rice and UT health?" 3:15 "You're saying the future of neural implants is additive depth electrodes. What does that mean?" 13:45 Sponsorship by Ripple Neuro 14:15 "What's the solution, to try to make them directional?" 16:30 "So you basically need your collector to be as small as possible?" 18:30 "So by finding the right size of the electrode and the substrate diameter you're able to have directional electrodes?" 22:45 "What's the advantage of your technology? What does it change?" 28:00 " If you had unlimited funding, what would you be able to do with it?" 33:00 What kind of differences of electrode design would you expect patient to patient? 34:45 "These few years ago, you said you were at Rice before, exclusively, and then now moved to both UT Health and Rice. What's that been like?" 42:00"Is there anything that we didn't talk about that you wanted to mention?"  

Andre Mercanzini is the Co-Founder and Chief Technology Officer at Aleva Neurotherapeutics which has worked in directional Deep Brain Stimulation (DBS) device leads for Parkinson's and other diseases. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services here*** Top 3 Takeaways:  "We realized during that time that the intervention that could benefit the most from the miniaturization technologies was by far and away, deep brain stimulation." "MEMS allowed us to align every single electrode into its position, have it almost prewired and decrease the amount of touch time that an operator would have to spend on the device as they're manufacturing it, which, which gives us a price advantage as well."   "My advice to PhD students postdocs, physician inventors, and professors working on neuro technologies is that you have to work on something that will make a major change in patient outcomes. It cannot just be incremental. If it has any signs of only being incremental, it will be very difficult to get funded. It will be very difficult to get your early adopters to sign up and use or test your device. It's always a difficult metric to determine what that means. Is it a 20% improvement in symptoms? Is it a 40% improvement in symptoms? Is it treating a disease that is not treatable today? That is really the major choice you have to make as an entrepreneur in your own technology is whether your work will make a significant change in patient outcomes." 0:30 "Do you want to explain what Aleva does a little bit and a little bit of your background?" 3:30 "What would you say that is a special thing in Lausanne that maybe other places could copy or are not able to copy?" 5:00 "Let's talk about Aleva" 6:45 "Iris Biomedical ad sponsorship" 7:15 "What's DBS and how did Aleva get started? You were saying this spun out of your PhD work. What did that look like then? And maybe how has it changed now?" 13:15 "Why is having directional leads was such a design problem?" 16:45 "What has the evolution been in the last decade, and then maybe what's future directions?" 20:30 You raised $70 million to get through the regulatory pathway, this seems like alot, couldn't you do it with 5 or 10 million? 23:30 Surgeons often like to stick with what they know, do you know if there would be a demand for what you are making? 25:45 Do you want to talk about wearables and how this fits in with your company? 29:00 "What advice do you have for people who want to follow in your footsteps and want to, create, raise $70 million and do you have to be in Switzerland to do this?" 31:45 "You've raised a lot of money and so is that good or bad and aren't you worried about being diluted too much?" 34:00 " Is there anything that we didn't talk about that you wanted to mention?"

Vailiki Giagka is an Assistant Professor at TU Delft and Research Group Leader at Fraunhofer IZM in Berlin where she conducts research on the design and fabrication of active neural interfaces. ***This podcast is sponsored by Ripple Neuro, check out their Neuroscience Research Tools here*** Top 3 Takeaways: "Water vapor is not dangerous for neural devices, it will not cause your metals to corrode, as long as it remains in the form of vapor. The moment it condenses into liquid water and you have ions in there, is when corrosion can start, and that is the beginning of the end" Conformal polymer coatings have been implanted in bodies for decades but we lack means to prove upfront the amount of time a certain coated device would last in the body "Our aim is not to create startup ourselves, but it is really to help this ecosystem by supporting companies working on this" 0:30 "How do you work in Berlin and the Hague in the Netherlands at the same time? 2:30 "Why especially neural device packaging?" 5:15 "What's the size of your guys' device or packing?" 7:15 "Do you want to, do you wanna describe the neural implant network mesh a little bit more and how does it work and why is it necessary?"  9:15 Sponsorship by Ripple Neuro 9:45 "So let's talk about maybe conformal coatings. What is it, how does it work? Why is it necessary?" 19:00 "So what are some rough numbers, is one method better than the other, and then how many years of simulated life can one survive versus the other?" 21:45 "So how do we test it? How do we do the accelerated testing to be able to simulate a human lifespan?" 25:00 "So now you also work on the wireless power delivery, wireless transmission. How is this, how does this work? Why is this important?" 31:00 "Neurons fire with electrical signals and you're using ultrasound. So how does that work? Why is it able to work?" 32:00 "How does the power usage compare with electrical or ultrasound cuffs?" 33:30 "Let's talk about your graphene work." 37:30 "These three areas that you're working on, these all seem like very good candidates for, a spinoff company or some kind of, patents. Have you thought about this?" 42:00 "If you had unlimited funding, what would you do?" 43:45 "Is there anything that we didn't talk about that you wanted to mention?"

Dr Jacob George is an assistant professor at the University of Utah where his NeuroRobotics lab seeks to augment biological neural networks with artificial neural networks and bionic devices to treat neurological disorders and to further our understanding of neural processing. ***This podcast is sponsored by Ripple Neuro, check out their Neuroscience Research Tools here*** Top 3 Takeaways: "I'm 28 years old. So very young still getting stuff set up and really kickstarting it. The average age that NIH states for someone to get an R01 is somewhere around 47 years old and they really wanna change that. They wanna get people into science earlier. And so that's the mechanism that I went through and so very fortunate to have that funding to kick start stuff."  "The idea is, you had a stroke, you wake up in a hospital, you get the fitted with this bionic arm that helps you move immediately. So it's like nothing happened. And as you're doing these things in your real world life, all of a sudden. You don't need the exoskeleton anymore because your hand's back to use because you have rehabilitated yourself." "A one-off grant is great, that's luck, if you get one thing that's luck, but repeatedly, being successful in funding starts to show a pattern of success that is more and more unlikely that it was just luck." 0:45 "Do you want to introduce yourself?" 2:30 "You're also a pretty new professor. How old are you also?" 4:30 "How did you get into this field?" 6:15 Sponsorship by Ripple Neuro 7:00 "Do you want to go in a little bit more in-depth about the different aspects of your research and maybe we could start with the Luke arm." 13:45 "So what does the training look like for the patients?" 17:00 "That calibration sounds tedious. How long is it?" 19:45"Is glial scarring also a problem in the peripheral nervous system or is it worse, better? How does it compare to the central nervous system?" 21:00 "Do you wanna talk a little bit about exoskeletons?" 25:45 "Which one do you love more, invasive or noninvasive?" 30:30 "What's especially motivating you to deal with this specific patient population?" 33:00 "Do you have any tips for people who might want to fall in your footsteps of being a young professor?" 36:45 "How similar is your training between, what you're doing at the PhD, working at the bench versus, being a professor and, needing to find those dollar bills?" 39:45 What specific exercises would you recommend for finding funding? 44:45 "Is there anything that we didn't talk about that you wanted to mention?"

Ana Maria Porras is an Assistant Professor at the University of Florida working on human-microorganism interactions and science communication especially in different languages.  ***This podcast is sponsored by Ripple Neuro, check out their Neuroscience Research Tools here*** Top 3 Takeaways: "Sometimes we see science communication as a way to convince more people to work in STEM but I think it's important beyond that. It's important that you understand the basis of how we do science and why we do science" "We think of science communication as what's happening when people go viral. But you can do a ton of great science communication in your immediate community. With your family, with your friends, with people in your community around wherever it is that you live." "Sometimes you learn a ton of stuff and then you realize it was all the wrong stuff. I think science communication is like any other scientific discipline. There are scholars, there are best practices. There are people who have been doing the research." So just like in any other scientific discipline, it's like important to acknowledge that there's like a whole ton of work that other people have done so that we don't always have to go and reinvent the wheel." 0:45 "Do you wanna introduce yourself better than I just did?" 1:30 "What exactly do you study and why is it important?" 4:45 Sponsorship by Ripple Neuro 5:00 "Let's talk a little bit about your experience with science communication. Why is it important?" 10:30 "Let's talk about the science communication and different languages" 13:15 "What's the reception been like?" 15:45 "For people who want to learn a little bit more about science communication, what do you recommend?" 19:00 "Are the science communication groups helpful or how much of what percentage of what you've learned has come from that versus just doing it?" 21:15 "Is there anything that we didn't talk about that you wanted to mention?"