Medical Device Startups and FDA (blog post)

2017-03-31T01:32:05Z

Iris2017:

{{BlogPost
|Has title=Medical Device Startups and FDA
|Has author=Iris Huang
|Has content status=Peer Edit
|Has graphics status=Selected
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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.”

Medical Device Startups and FDA (blog post)

2016-11-22T22:16:59Z

Iris2017: Created page with "{{BlogPost |Title=Medical Device Startups and FDA |Author=Iris Huang |Content status=Outline }} Audience: If you are considering medical devices at all, you have heard of FDA,..."

{{BlogPost
|Title=Medical Device Startups and FDA
|Author=Iris Huang
|Content status=Outline
}}
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.”

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Medical Device Startups and FDA (blog post)

Medical Device Startups and FDA (blog post)