Medical Device Startups and FDA (blog post)

Jump to navigation Jump to search

Blog Post
Title Medical Device Startups and FDA
Author Iris Huang
Content status Peer Edit
Graphics status Selected
Publication date
©, 2016

Audience: If you are considering medical devices at all, you have heard of FDA, and you are probably worried about it.

Problem and consequence: There is a lack of info and guidance for the process, which may prevent innovation in the medical devices space. Startups go to market in Europe first.

Especially difficult for startups: small team, limited funding, no prior experience with FDA. The rigid regulations were written long before these innovations were considered possible.

Trend: increasing VC investments in life science and more regulatory scrutiny.

Importance and necessity: You could get in trouble if you don't get clearance. FDA clearance will bring your business credibility and possibly tremendous profits.

What to do: You should be doing the work anyway. Embrace it and work with FDA staff. Examples like Uber, Airbnb.

Interviews: 3 companies with different status.

New programs and resources: DICE, SBA&FDA, Shiftlabs Github open source.

Bottomline: “there are fees you have to pay, regulatory compliance testing labs, and outside expertise that costs money.”