The U.S. Food and Drug Administration (FDA)’s Innovation Pathway 2.0 program is focusing on the evolution of medical devices for patients with end-stage renal disease (ESRD), which afflicts more than half a million Americans. On April 9, the FDA announced the selection of three developers who will work collaboratively with the agency on benefit-risk profiles and regulatory paths for their ESRD products.
The FDA said it wants to shorten the time and cost it takes for the development, assessment and review of medical devices, in particular breakthrough medical devices.
A January 2012 request from the FDA’s Center for Devices and Radiological Health (CDRH) prompted 32 applications – most of which came from small, start-up businesses or academic institutions -- to take part in the program. CDRH chose the following three products from the applicant pool:
- an implantable renal assist device being developed by the University of California, San Francisco;
- a wearable artificial kidney in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.; and
- a hemoaccess valve system designed by Greenville, S.C.-based CreatiVasc Medical.
“The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction,” said Jeffrey Shuren, MD, director of the CDRH, in a prepared statement.
Patients with ESRD progressively lose kidney function over a period of months or years. Management of the disease is largely dependent upon medical device technology, such as hemodialysis equipment. Most dialysis patients spend long hours in specialized outpatient clinics, impacting their quality of life and reducing productivity. Medicare alone covers some 75 percent of ESRD healthcare costs, which in 2009 topped $29 billion.
“We found ESRD a natural fit given that patients have few options. We think this process could impact the lives of patients by providing access to innovative new technologies they so desperately need. In turn, this could also have a positive impact on healthcare, encouraging innovation through smarter regulation that could potentially save companies time and money,” said Shuren.
Photo credit: University of California, San Francisco.