A year after its launch, the National Evaluation System for health Technology (NEST) is on its way to becoming the kind of program envisioned by US FDA to shake up the medical device ecosystem. Over the past year, the NEST Coordinating Center (NESTcc) has gone from a staff of one to five. It also started working on demonstration projects to show how real-world evidence can be used to support product submissions, and is working to develop a network that would allow manufacturers and institutions to share research data.
Changing how the agency reviews medical devices, where traditionally approvals rely heavily on pre-market trial data, has been a calling...
