Silver Spring, MD – The US Food and Drug Administration (FDA) has unveiled a new nonprofit, public-private partnership that aims to speed safe medical devices to market, in part by encouraging otherwise-competing manufacturers to pool their knowledge about product testing .
One example of how this collaboration might bear fruit is the development of a standard computer model of the heart for testing valves and such, said Dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press conference yesterday.
“If I have a model of the heart that includes not only the anatomy but the blood flow and the dynamics of the blood, I can . . . test-drive different configurations of that valve and can get a better understanding of what [it] can do without having to test it in an animal or person initially,” said Shuren. “That can reduce a lot of time and cost in bringing that product to market.
“That’s a winner for patients, for companies, and ultimately a winner for our healthcare system.”
The new partnership, called the Medical Device Innovation Consortium (MDIC), was created by LifeScience Alley, a biomedical science trade association. Founding MDIC members include the FDA, the US Centers for Medicare & Medicaid Services, LifeScience Alley, Medtronic, Boston Scientific, the Pew Charitable Trust, and the National Organization for Rare Disorders. Organizers envision bringing aboard leaders of academia as well as industry and government.
FDA commissioner Dr Margaret Hamburg said at the press conference that MDIC represents the first public-private partnership devoted to improving the science of assessing the safety, efficacy, and quality of new medical devices. Most device makers, Hamburg noted, are much smaller than pharmaceutical companies and have fewer resources for “regulatory science.” There is strength in numbers, however.
“We really needed to create a safe-haven organization to foster precompetitive collaborative research,” she said.
Serving as the interim executive director of MDIC is Dr Maura Donovan, recently the vice president of therapy research and development at Medtronic. Her initial responsibilities will entail recruiting a board of directors and launching subcommittees that will identify and direct specific research projects.
Avoiding the time, expense of animal studies
Shuren said it was premature to talk about research priorities because MDIC has yet to solicit and sift through ideas. However, he threw out two tantalizing hypothetical examples. One was computer modeling of the heart. The second dealt with neurological devices that use implanted electrodes to stimulate the brain and treat disorders such as Parkinson’s disease or help patients control prosthetic limbs with their thoughts.
“One of the challenges, though, is that those electrodes can degrade,” said Shuren. “We didn’t have great tests for assessing them. We don’t want to use people as guinea pigs.”
One answer is conducting tests with an artificial human brain, which is already being developed, he said.
“That would help you to better understand what a particular electrode may do, how durable it is, what the impact may be on the brain . . . and design a better device before it ever gets to patients,” he said. In the process, researchers could avoid the time and expense of less productive animal studies.
MDIC is not related to a nonprofit group with a similar name—the Medical Device Innovation, Safety and Security Consortium.
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- Food and Drug Administration. FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies [press release]. December 3, 2012. Available here.
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Source: Heart Wire