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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

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

is the President and Chief Product Officer at 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 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...

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

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

 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  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...

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

is the Head of Neurotechnology at 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 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...

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Lindsey Jardine talks all about clinical trials for neurotech show art Lindsey Jardine talks all about clinical trials for neurotech

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

is a clinical project manager at Boston Scientific which had acquired , 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 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...

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

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

is the founder and CEO of 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 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...

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

is an in Neurosurgery and at 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 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...

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

is the Co-Founder and Chief Technology Officer at 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 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...

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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?"