Medical Devices

Digital Health Entrepreneur-in-Residence Program

Do you have experience in digital health? Are you passionate about developing innovative solutions to complex challenges? If so, consider joining the FDA Digital Health team as an Entrepreneur-in-Residence! The Center for Devices and Radiological Health (CDRH) is establishing this Entrepreneur-in-Residence (EIR) Program to support and help develop our Software Precertification (PreCert) Pilot Program —a critical piece of our Digital Health Innovation Action Plan, announced on August 8, 2017.

The Pre-Cert Pilot Program is a voluntary program that will enable us 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 what we currently do for more traditional medical devices. This pilot will help FDA establish the most appropriate criteria for standing up a firm-based precertification program.

Duties

EIR Fellows 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.

Qualifications

FDA is seeking creative problem-solvers, innovators, and entrepreneurs with expertise in the following domains:

  • Software design, development and validation processes, including quality management systems;
  • Business process modeling, analysis, and improvement;
  • Business metrics development, including key performance indicators;
  • Clinical trial design, post-market surveillance, and the use of real world evidence;
  • Decision analysis, including management of trade-offs and uncertainty; or
  • Investment and business valuation

Candidates for the EIR program are required to have a minimum of five years of work experience in at least one of the above domains. An advanced degree in computer science, engineering, or similar fields is preferred.

Duration

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. Selection for the EIR program is temporary in nature, and will not result in a permanent federal position.

Appointment Type

EIR Fellows may be hired by FDA as contractors or term employees, dependent on qualifications and type of expertise. If selected, candidates will be required to undergo a background check, and may be subject to ethics clearance and divestment requirements.

Application Process

The FDA will accept applications for Digital Health EIR candidates between September 6 and September 29, 2017. Candidates should submit a current resume or curriculum vitae, which summarizes any work experience, training or skills relevant to this position, together with a statement of interest. Please submit your information via e-mail to FDAPre-certpilot@fda.hhs.gov with “Pre-Cert Pilot: EIR” as the subject line.
 

Page Last Updated: 09/11/2017
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