Article preview from "The Gray Sheet" - October 22, 2012
FDA’s device center launched the second round of its entrepreneurs-in-residence program, bringing in outside experts to the center to focus on streamlining data collection and the approval-to-reimbursement pathway.
Article preview from "The Gray Sheet" - October 22, 2012
Members of the second iteration of CDRH’s entrepreneurs-in-residence program met for the first time last week, hatching plans to streamline the device data-collection process and to create efficiencies in the pathway from approval to reimbursement.
As with the first go-around of the program, which started last October and wrapped up this spring, the device center has tapped members of its staff to work with outside experts to rethink some of its processes, with an eye toward facilitating innovative product development.
The new group met for a kick-off retreat Oct.15-16 at the Office of Personnel Management’s Innovation Lab in Washington, D.C.
The focus of the previous entrepreneurs in residence was to develop the Innovation Pathway 2.0 program to bring innovative, breakthrough technologies onto the market more efficiently with enhanced, earlier-stage collaboration and new regulatory tools. FDA is currently piloting that program for three innovative investigational-stage devices to treat end-stage renal disease.
“The first group worked specifically on setting an innovation pathway, which will continue to morph and change as we go,” Peper Long, CDRH’s associate director for external relations, said in an interview. But the new group will have a broader focus, she suggested.
Continued...
To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to "The Gray Sheet".
Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512
Comments