John Doucet on helping companies get FDA approval at MCRA

John 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:

• "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?"