Founders of medical device startups, how do you stay informed?

Question

I wanted to include "successful" in the title, but alas, that was too long! I'm the technical cofounder of a medical device startup that's about to enter our first-in-man trials in the USA (Class II de-novo). Learning about regulated industries is difficult for startups, and while I think our team has done a fantastic job of learning the basics (including successfully submitting our Investigation Device Exemption), it has been an incredibly long slog of YouTube lectures, random blog posts, and occasional conferences to build the necessary knowledge to bring this product to market.What groups are you part of, blogs do you read, books can you recommend etc etc that have proven helpful in your journeys?Also feel free to plug what you're doing, always interested to hear what projects other people in this space are up to!

jdale27 · Accepted Answer

Not exactly in the same industry, but I worked in a genomics startup that was subject to various aspects of HIPAA and CLIA compliance. In our case this led us to implement ISO 27001/27002 and eventually FedRAMP. The answer is: consultants. There are people who make it their full-time job to keep up with the regulations and advise companies on how to comply with them. This is a good place to start when you are too small to have dedicated compliance staff, or too new to understand how to hire good ones. If you have advisors or board members who are experienced in the space, they should be able to connect you with good people. If you /don't/ have advisors or board members who have been through the process successfully with other companies, that seems like a bit of a red flag tbh and a gap you'll want to fill.