John Doucet on helping companies get FDA approval at MCRA
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
Release Date: 11/22/2021
Evan Coopersmith on how software is just as important as hardware in neurotech machine learning
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
is the galactic head of admonishment and also executive vice president of data science at . There they do contract work for machine learning in neuroscience and neurotech. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services Top 3 Takeaways: "One of the arguments I've often made is that it isn't only the hardware that holds us back. It is the software. When the software reaches a level of sophistication, suddenly the hardware is orders of magnitude more impactful." "Clearly we have learned how to understand patterns. We call these latent...
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Kirill Korotaev on accessible eye tracking for neuroscience research- Purple Gaze
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
is the CEO and founder of which is an AI Platform for collecting data from the brain using eye movements. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services Top 3 Takeaways: "There wasn't any significant innovation in the eye tracking technology for the last 15 years. And we thought that if we use modern computer vision and image processing techniques, we could make it much more accessible and easy to use, which in turn would open up new applications and create whole new industries." "We've just launched in the United States. The Communication...
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E.J. Chichilnisky on what it takes to reproduce the neural code of the retina
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
is a Professor of Neurosurgery and Ophthalmology at Stanford University. His research has focused on understanding the spatiotemporal patterns of electrical activity in the retina that convey visual information to the brain, and their origins in retinal circuitry, using large-scale multi-electrode recordings. His ongoing work now focuses on using basic science knowledge along with electrical stimulation to develop a novel high-fidelity artificial retina for treating incurable blindness. ***This podcast is sponsored by Ripple Neuro, check out their Neuroscience Research Tools Top 3 Takeaways:...
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Duane Mancini on the Project Medtech and Medtech Money Podcasts
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
is the host of the which talks about Medtech Device industry. They talk about the success storiies, advice, pitfalls, trends and more. Duane also helps run which accelerates medical technology to improve patient lives. Finally, Duane and Giovanni Lauricella have started the about how to raise money for medtech companies. Top 3 Takeways: "Actually defining the problem too is a big issue. And it's something that I didn't really realize was an issue. They're asking questions that are going to validate their problem rather than actually going out and doing some in-depth research. Is this...
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Jack Gelman and Brock Lindsey on targeted muscle reinnervation for amputees
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
Brock Lindsey and Jack Gelman are researchers at West Virginia University. Brock is an orthopedic oncologist who deals with bone and muscle tumors. Jack is a plastic surgeon interested in peripheral nerve surgery. Together they work on targeted muscle reinnervation in osseoimplants to bring back control for amputees. Top 3 Takeaways: Integrating prosthetics into the bone allows for better bone health since the bones are then under load Neuromas are transected nerves that continue to grow and cause pain. They've removed some that are the size of golf balls WVU has done 28 of these...
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Neuralink's animal abuse, what you need to know
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
A few weeks ago the Physicians Committee for Responsible Medicine (PCRM) based on a Freedom of Information request to look at the records of animals involved in trials at Elon Musk's Neuralink company. PCRM alleges that 15/23 monkeys used in the experiments have died and that they have been treated poorly. In a rare move from a Musk company, Neuralink published a explaining their position explaining some of the nuances of what happened. In this episode, I go over some of the facts of this case, my experience with animal studies, and then play a good which goes into more detail. ...
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Karandeep Singh Badwal on building quality and regulatory at the start of your neurotech idea
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
is a Quality and Regulatory Affairs Consultant in the field of Medical Devices. He is also the host of the MedTech Podcast where he talks to leaders in the field of Medical Technologies Top 3 Takeaways: "Once you understand your product, who's going to be using it, you can then build a risk assessment around that. But if you do not know what your product is, and you do not know the modes of failure, you really are going to struggle with this process." "So the UK is relatively easy for software devices. The EU has now become more difficult. Whereas previously the EU was considered to be...
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Radhika Gupta and Adam Sefler on Neurotech Consulting from NeurotechX Services
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
Adam Sefler and Radhika Gupta head up which is a distinct for-profit entity affiliated with the non-profit NeuroTechX. They offer consulting and recruitment services with the vision to aid in the commercialization of neurotechnology at a global scale. Top 3 Takeaways: "Our projects range from [client] projects coming right out of labs, to setting up a whole new division for a larger company, to describing and setting the marketing strategy for an [international] startup, to doing C-level executive search[es] on the recruiting side, but […], that's by no means a complete list of...
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Mark Domyahn on marketing, regulatory, and reimbursement strategies for neurotech companies
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
Mark Domyahn is a partner at JD Lymon where they help companies develop healthcare strategies. They help companies understand their unique value proposition and optimize their market potential. Top 3 Takeaways: "the FDA writes zero checks. They give you a license to hunt, but they don't guarantee you kill anything" "What I'm hearing more and more is the first question out of investor's mouth isn't what's your FDA pathway, it's what's your reimbursement strategy. Because FDA is at least a somewhat known entity. And they're the last entity that will tell you as a company "if you do this...
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Tim Marjenin on helping neurotech companies do better storytelling for the FDA
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
is the Vice President of Neurology Regulatory Affairs at MCRA where he helps neurotech companies get through the challenges of being approved by the FDA. Tim has had over 16 years in the regulatory side of things before now advising the companies. Top 3 Takeaways: "A big part of what I'm doing right now. It's trying to help them figure out, okay. What are you trying to do? How can I help you put that in FDA's language and language that FDA is going to understand?" "I think probably the biggest success is that Applied VR got their Denovo granted just a few weeks ago. We supported them...
info_outlineJohn Doucet is a neuroscientist and biomedical engineer with 10+ years of FDA experience in medical device regulation, and 13+ years of Johns Hopkins experience in discovery science, and 6+ years of management experience at FDA and Johns Hopkins School of Medicine. He has extensive knowledge of medical device regulatory pathways to drive technologies from conception to market.
Top 3 Takeaways:
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"That's what clients are paying for, I can detect the signal from the noise and all the stuff the company is doing, bring that to the FDA in a way that they can digest it
- "Everyone wants breakthrough device. If you're like talking to an investor, you want to say FDA labeled us a breakthrough device. "Yes, our device is the greatest thing since sliced bread, FDA thinks so too.""
- "One of the reasons, I left the FDA and I'm on this side with MCRA working directly with clients is I'm hoping that I can scrub some delays away"
- "I feel like I'm still protecting and promoting public health"
1:15 "Do you want to introduce yourself a little bit?"
5:30 "What is regulatory? Why is it necessary? Why do people like you in your previous life, at the FDA, why does that have to exist? And then why do you and your current life, why does it have to exist?"
10:30 "People should come to you even pre-submission, to be able to consultant and figure out how best to pitch it to the FDA so that it could be approved?"
16:15 "A lot of times when like politicians then become like contractors, it's like a revolving door. What do you think about that? Is it like you're using your connections or what are the ethics of that?"
18:00 "And what's your opinion on the field of neuro tech is it growing exponentially? Have we hit the hockey stick part of the growth?"
24:00 "Is there anything that we didn't talk about that you wanted to mention?"