New medtech partnership aims to streamline reviewsby Martin Moylan, Minnesota Public Radio
ST. PAUL, Minn. — The Food and Drug Administration will collaborate with a public-private partnership conceived by LifeScience Alley, a trade group for Minnesota's medical device companies.
The FDA, academic researchers, and device companies across the county will all be part of the Medical Device Innovation Consortium. The goal is to speed up the development and federal review of medical devices.
"This consortium is truly ground-breaking," said FDA Commissioner Margaret Hamburg. "It creates a safe space to collaborate on early-stage regulatory science efforts that will eventually benefit the entire industry: the advancement of innovation and ultimately, and most importantly, patients."
The industry has long complained FDA evaluations are overly burdensome and slow. Shaye Mandle, a spokesman for LifeScience Alley, said organizations joining the consortium will look for ways to safely expedite medical device evaluations.
"Computer models, tools, technology development that can be done collaboratively that would benefit the entire industry that might produce faster pathways to product development," Mandle said.
The location, staffing and budget of the consortium have yet to be worked out. Medtronic executive Maura Donovan will serve as interim executive director.