A clear understanding the total product life cycle of a medical device requires much more data than is available in routine regulatory submissions. The FDA has recognized that a national system to collect and analyze Real World Data (RWD) and convert it to Real World Evidence (RWE) would provide a body of information that patients and providers could use to make better informed treatment decisions and the agency to strike the right balance between assuring safety and fostering device innovation and patient access. That system is known as the National Evaluation System for Health Technology. The history of the system is fairly lengthy and is available at the FDA NEST website.

NEST’s current research includes 11 demonstration projects to provide proof of concept data that RWE can be generated across a range of medical device types. Examples of device types include in vitro diagnostics, electrophysiology devices, and peripheral interventional devices. Also included are 8 test cases on how the medical device industry might work with RWD and the NESTcc team. These test cases include products representative of all of the device regulatory pathways in 5 disease areas and across the product lifecycle. Examples include evaluation of effectiveness of methods of wound closure and the clinical outcomes of patients with mechanical heart valve replacements. Another round of test cases is currently in the works, and you can read more about upcoming activities and operations at the NEST Coordinating Center website. Given the reorganization of CDRH towards structure focusing on the total product lifecycle of devices, I expect we will hear more about NEST this year.

Text Copyright © 2019 Katrina Rogers