FDA to partner with medical device makers
The Food and Drug Administration said Monday it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.
The agency said it hopes to offer guidance to the Medical Device Innovation Consortium, a new industry-backed group that aims to simplify the design and testing of medical devices.
FDA Commissioner Dr. Margaret Hamburg noted that many medical device companies are small businesses and don't have the research budgets to find more effective ways of testing their products. She said the new group would pull information and ideas from industry, government and academia.
"This can best be done by making sure we're applying the best science to the task and bringing together the best minds, no matter where they are found," Hamburg said in a teleconference with reporters.
On Long Island, officials have long hoped that innovations at Cold Spring Harbor Laboratory, the Feinstein Institute for Medical Research, Stony Brook University and other research institutions would yield high-tech companies and stimulate local job growth.
The FDA's pledge to make that process easier follows criticism from device industry advocates, who have lobbied Capitol Hill for more than a year to fix FDA procedures they say are forcing some companies out of business.
Medical device makers have criticized the FDA for an overly burdensome system of reviewing devices, which they claim slows down development of important new therapies. They point to some device companies that are launching their products in Europe, where the bar for approval is lower.
In recent months the FDA has been highlighting efforts to slash red tape and accelerate review times.
The new consortium will take suggestions from its members on initial projects for research. The group has raised about a half-million dollars from industry members and hopes to double that the first year, said interim director Maura Donovan.
The Medical Device Innovation Consortium was created by LifeScience Alley, a Minnesota-based group that includes companies like Minneapolis-based Medtronic Inc., the world's largest medical device company. With Joe Ryan
