April 18, 2022
Five years ago, the Food and Drug Administration launched a new program with the best of intentions: to speed the development and review of cutting-edge and potentially lifesaving medical devices, all in the name of getting them to patients faster.
The initiative, known as the Breakthrough Devices Program, was set up to identify devices that the agency believed could provide “more effective” treatment or diagnosis for deadly and debilitating conditions than the current standard of care. And it came with perks: Among them, manufacturers of devices that receive the designation — more than 650 products so far — are given the opportunity to talk more often with regulators and design flexible clinical trials, potentially easing the path to market.
But a STAT investigation has found that while the program has delivered big benefits to companies making devices, its value to patients is still far from clear.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
About the Authors
To submit a correction request, please visit our Contact Us page.
