Hosted by Dr. Eugene Krentsel, Chief Scientific Officer, XLerateHealth
How the FDA’s Center for Devices and Radiological Health Helps Accelerate
Upstream Medical Device Innovation
Promoting public health is the mission of the Food and Drug Administration (FDA). As the breadth of technology increases linearly, early-stage innovators face unique technical challenges. Many of them deal with emerging medical technologies that may have no precedent for assessing safety and effectiveness. This means they may have to develop their own ad-hoc testing methods, which is not their specialty. This is time-sensitive and capital-intensive. And they’re doing this at the same time that they are focusing on product innovation.
This event will share insights on how the FDA’s Center for Devices and Radiological Health (CDRH) and its research arm, the Office of Science and Engineering Laboratories (OSEL), help accelerate upstream medical device innovation through the development of a common toolset to assist with development and assessment emerging medical technologies. It will also offer an opportunity for discussion on means to promote collaborative problem solving across industry and academia.
Funds for the XLerator Network hub were made possible by a Small Business Technology Transfer (STTR) award (UT2GM130174) from the National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health (NIH)