With thousands of devices -- sometimes leveraging cutting-edge technology -- to examine each year, the US Food and Drug Administration (FDA) is faced with the challenge of finding the right internal and external expertise to help the agency quickly study a device’s safety and efficacy. Done right, lives can be saved and companies can prosper from bringing innovations to market. Done wrong, bad devices kill.
As one of its duties, the Food and Drug Administration manages the process of pre-market approval of all medical devices to ensure that patients and providers have timely access to safe, effective, and high quality devices, as well as the post-market review of medical devices to ensure that any unsafe medical devices are identified and recalled from the market. In both of these contexts, the FDA seeks to provide the medical device industry with productive, consistent, transparent, and efficient regulatory pathways.
In a pilot program, the GovLab, MacArthur Foundation Research Network on Opening Governance and partners will evaluate several potential impacts of the introduction of a piece of expert networking software, FDA Profiles. This software is designed to decrease frictions in identifying qualified government employees to participate in medical device regulatory review panels. FDA Profiles aggregates information about the expertise of potential reviewers including information from internal databases, publications on PubMed, and self-reported information about an individual’s skills and experience.
The experimentation around the rollout of FDA Profiles will allow researchers to identify how and when changes in the assembly, composition, and efficiency of a review panel change when expert networking software is introduced and will identify the impact of the software on each of these factors.
Additionally, the agile empirical manner in which the experimentation will occur will seek to accelerate the pace of research by developing replicable methods for studying governance innovations in the wild.