Jan 31, 2022

Tim Marjenin 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 in their de novo, but we helped them quite a bit with with writing the de novo and interacting with FDA throughout that process."
• "Probably the biggest tip that I always have is. Try and put yourself in FDA shoes. One of the examples: say you're in an engineering class and you're turning in some homework or you're turning in a test. Is a professor really just interested in the answer? No, he wants to know how you got to the answer. FDA is going to be the same. If they don't understand how you got from a to B, they're going to have a lot of questions about that."

0:45 "Do you wanna describe yourself a little bit? "

2:45 "What does the day-to-day look like in the FDA?"

5:30 "So for those that don't know, what is the FDA review process look like? How many people are reviewing it, what's the timeline?"

7:45 "How many people are involved in this whole process, is the weight of millions of people's lives resting on one person's shoulders, or is it more like a committee?

9:30 "What do you do at MCRA?"

10:45 "How has your job changed?"

13:45 "You wanted to share some successes that maker has had, do you want to talk about these?"

15:30 "What does it mean to get a de novo status?"

19:00 "What's timeline from start to finish for your guys' work?"

20:30 "What are some things that people do that they shouldn't do?"

23:00 "Is there anything that we didn't talk about that you wanted to mention? "