The Medical Device Innovation Consortium, a government-private partnership, has received a nearly $500,000 U.S. Food and Drug Administration contract to study patient preferences about medical devices.
The one-year study will try to identify "scientifically valid ways to reliably assess patient views on the potential benefits and risks of specific devices." Today there aren't any guidelines on how to collect and use that type of data, the consortium said.
The Minneapolis-based group was formed in 2012 as a partnership between the FDA and the medical device industry to improve the way medical device safety is regulated.
"The comparison of benefits and risks that is critical to the regulatory process should include the perspective of patients, since they're the ones taking the risks … to achieve clinical benefits," Bill Murray, the consortium's CEO, said in a statement.
Steve Alexander
