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Lindsey Jardine talks all about clinical trials for neurotech

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

Release Date: 10/24/2022

Paul Le Floch: Pioneering Neural Implant Materials with Axoft show art Paul Le Floch: Pioneering Neural Implant Materials with Axoft

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

 "Welcome to today's episode! Our guest, , co-founder and CEO of , 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...

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Christine Schmidt: Pioneering Regenerative Neural Tissue Engineering show art Christine Schmidt: Pioneering Regenerative Neural Tissue Engineering

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

Today’s guest is who is a 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...

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Bioel 2024 Conference panel with Drs Jon Viventi, Tracy Cui, Ellis Meng, and Ivan Minev show art Bioel 2024 Conference panel with Drs Jon Viventi, Tracy Cui, Ellis Meng, and Ivan Minev

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

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 . (LCP neural implants), (PEDOT electrode coatings), (parylene neural implants), and (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...

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

In today's episode, we're joined by , 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...

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Steve Goetz: Revolutionizing Mental Health Treatment as CTO of Motif Neurotech show art Steve Goetz: Revolutionizing Mental Health Treatment as CTO of Motif Neurotech

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

is now the Chief Technology Officer at 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...

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

is a research group leader at the Central European Institute of Technology () 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  Top 3 Takeaways: "You can just buy stuff on the internet very simple red...

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

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...

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Kurt Haggestrom on Synchron's Stentrode and Synch Switch show art Kurt Haggestrom on Synchron's Stentrode and Synch Switch

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

comes on to talk about the latest new from , 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 *** 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...

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Pawel Soluch on launching the Medtech Coaching program with me show art Pawel Soluch on launching the Medtech Coaching program with me

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

Pawel Soluch is a returning guest who goes over his work at , then his consulting at , and now finally he talks about the program that he is launching with me! 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...

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Mounya Elhilali on her auditory processing selectivity research show art Mounya Elhilali on her auditory processing selectivity research

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

did the keynote talk at the . 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. ...

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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?"