The Food and Drug Administration is seeking digital health entrepreneurs in residence to help develop and support a one-year software precertification pilot program.
As part of the FDA’s Digital Health Innovation Action Plan released last month, the regulatory agency will select a cohort of as many as six fellows under the entrepreneurs in residence (EIR) program tasked with developing and testing key conceptual elements of the pilot for software developers.
The pilot 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,” the FDA’s announcement notes. “This pilot will help FDA establish the most appropriate criteria for standing up a firm-based precertification program for these new tools.”
Applications for the EIR Program, managed by the Center for Devices and Radiological Health (CDRH) at FDA, will be accepted until September 29. Specifically, the agency is looking for candidates with expertise in the following areas:
- 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
- Investment and business valuation
Applicants are required to have a minimum of five years of work experience in at least one of these areas, and an advanced degree in computer science, engineering, or similar fields is preferred.
EIR fellows selected for the program will “work intensively as embedded team members with FDA staff over the course of the one-year PreCert Pilot” for a minimum of three days weekly on site at the FDA’s White Oak campus in Silver Spring, Md., and “cultivate new ideas and fresh perspectives that will advance our vision to provide patients in the U.S. with access to high-quality, safe, and effective medical devices of public health importance first in the world,” according to the agency.
The duties of the EIR fellows will include 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; as well as identifying opportunities to improve processes and policies on data sharing and access.
Bakul Patel, associate director of digital health in the FDA’s CDRH, says the agency will use the pilot participants as “use cases” to ultimately build a formal precertification program “from the ground up from the concept level to actually figuring out specific elements,” including the criteria to assess whether a company consistently and reliably engages in high-quality software design and testing as well as ongoing maintenance of its products.
More information on the EIR Program can be found here.
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