This is an exciting time to work in the medical device industry. After decades of trying to determine the role of patient experience when creating regulatory policy, it appears answers may finally be coming.
The Medical Device Innovation Consortium released what it calls an “initial thought piece” in May, providing a guide for device makers seeking out information regarding patient preference when submitting data to obtain product approvals. The Consortium represents a joint effort of the device industry itself, the National Institute of Health and the Food and Drug Administration.
Ross Jaffe of Versant Ventures says that while patient preference is not required for a device manufacturer to obtain FDA approval, device manufacturers should consider it “an enhancement of a submission.”
In addition, device manufacturers benefit from the newly released FDA guidance that outlines just what patient preference information will be reviewed and considered by the FDA when weighing approval of any application for a new medical device.
For medical device manufacturers, these developments shed new light on an area that has always been frustratingly unclear. Device manufacturers can now use this information and these new guidelines to efficiently deliver proper applications to the FDA and get new, helpful medical devices on the market for the health-care facilities and patients in need, all more quickly than ever before.
To find all of the medical devices your health-care facility needs, contact Medical Device Depot today