FDA looking for digital health innovators for an entrepreneur-in-residence program

The initiative is designed to support and help develop FDA's Software Precertification (PreCert) Pilot Program.

FDA looking for digital health innovators for an entrepreneur-in-residence program

FDA is looking for a few experienced digital health professionals who are "passionate about developing innovative solutions to complex challenges" to join its Digital Health team as Entrepreneur-in-Residence (EIR) fellows. The Center for Devices and Radiological Health (CDRH) is taking this step to support and help develop FDA's Software Precertification (PreCert) Pilot Program, which is a critical piece of the Digital Health Innovation Action Plan.

The Pre-Cert Pilot Program is a voluntary program that will enable FDA to develop a tailored approach toward regulating this technology by looking first at the software developer and/or digital health technology developer, rather than primarily at the product, which is the current practice. This pilot will help FDA establish the most appropriate criteria for standing up a firm-based precertification program.

Entrepreneurs-in-Residence are expected to work as embedded members of the FDA Digital Health Unit team for a minimum of three days weekly on site at the FDA White Oak campus in Silver Spring, Maryland. Duties will include, but are not limited to:

  • 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;
  • Identifying opportunities to improve processes and policies on data sharing and access;
  • Participating in scheduled and ad hoc meetings with the Digital Health Unit team and/or Senior Office Staff; and
  • Providing additional counsel or services related to the EIR program as directed by the CDRH Center Director.

Candidates for the EIR program are required to have a minimum of five years of work experience, while an advanced degree in computer science, engineering, or similar fields is preferred.

FDA anticipates that EIR Fellows will commit to participate in the program for a minimum of 6 months, and not to exceed a period of two years. The applications are open through September 29, 2017.

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