Difference between revisions of "Medical Device Startups and FDA (blog post)"
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Audience: If you are considering medical devices at all, you have heard of FDA, and you are probably worried about it. | Audience: If you are considering medical devices at all, you have heard of FDA, and you are probably worried about it. | ||
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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.”
