FDA recruits entrepreneurs to support digital health precertification program

The Food and Drug Administration has begun officially enlisting digital health experts from the private sector to support a new digital health precertification pilot program that launched this month.

The FDA’s Center for Devices and Radiological Health is forming a team of “creative problem-solvers” through an Entrepreneur-in-Residence (EIR) program announced on the agency’s website on Wednesday. In an email to FierceHealthcare, FDA spokesperson Stephanie Caccomo said the agency expects to fill up to six slots.

The agency—which made a brief mention of the EIR program in its Digital Health Innovation Action Plan unveiled in July—will embed the selected fellows into the FDA’s new digital health unit, funded by the FDA Reauthorization Act of 2017 that was quietly signed into law by President Donald Trump last month. The experts will assist the agency with a novel approach to digital health innovation that regulates companies rather than products by fast-tracking developers that demonstrate a culture of quality and organizational excellence.

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Those selected for the EIR program will analyze business processes to help the FDA develop reliable predictors of quality, test data collection and analysis models, and help “identify requirements and input for a new digital health paradigm.” The FDA is searching for innovators with expertise in software design, decision analysis and business process modeling.

The private sector is poised to play an outsized role in the agency’s precertification program that will test the new approach using nine digital health companies. Caccomo said the FDA is still reviewing applications for the pilot that launched at the beginning of the month. An announcement is expected "soon." 

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Overseen by the Department of Health and Human Services’ Office of the Chief Technology Officer, the EIR program has supported 15 projects across nine HHS divisions. In 2015, the agency’s Center for Drug Evaluation and Research recruited experts with knowledge of software development, analytics and systems architecture to develop an electronic platform to aggregate data on cancer drugs.

Patrick Conway, M.D., the former deputy administrator for innovation and quality at the Centers for Medicare and Medicaid Services from 2011 until his recent departure to the private sector, credited the EIR program with changing the culture at CMS and streamlining the electronic clinical quality measure submission process.

“Any office at HHS that is facing a critical challenge and can identify the unique skill sets needed to solve the problem should look at the Entrepreneur in Residence program,” Conway wrote in a July blog post. “Innovators who are looking to make a meaningful impact at HHS are out there.”