As part of the U.S. Food and Drug Administration’s digital health action plan, the regulator is looking for a few experienced entrepreneurs-in-residence, according to its website followed up with a tweet from FDA Commissioner Dr. Scott Gottlieb. Led by the Center for Devices and Radiological Health, the initiative is intended to generate insights and feedback for the FDA’s Pilot Pre-certification program.
https://twitter.com/SGottliebFDA/status/905505445405712384
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The entrepreneurs would have to work in the FDA’s offices in Silver Spring at least three days per week and would be “embedded” in the FDA Digital Health unit. They would be expected to serve at least six months and no longer than two years.
Among the responsibilities highlighted on the FDA’s website are:
- Analyzing software industry business processes and key performance indicators to identify reliable predictors of product quality and organizational excellence;
- Developing and testing models of data collection and analysis;
- Collaborating with external stakeholders, pilot participants, and internal staff to identify requirements and input for a new digital health paradigm; and
- Identifying opportunities to improve processes and policies on data sharing and access.
Entrepreneurs-in-residence programs aren’t new to the federal government. The Department of Health and Human Services has had one since 2012 in coordination with the HHS IDEA Lab. They’ve been around the private sector for much longer with the idea of
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The FDA is developing a pre-certification program as a way of streamlining the review process for high-risk products from software developers who can demonstrate sufficient quality performance. For the pilot program, it is looking for input on criteria to help the program succeed.
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