Dec. 3, 2012
FDA Commissioner Margaret Hamburg, MD, today announced a new public-private partnership to develop regulatory science that will speed patient access to new medical device technologies. This is the first public-private partnership specifically focusing on this need.
It’s a very important initiative, and NORD is honored to be the sole representative of the patient community among the founding members of the new Medical Device Innovation Consortium. It’s a responsibility we will take very seriously.
Senators Amy Klobuchar and Al Franken participated in the announcement this morning, as did representatives of several companies with a strong history of involvement in medical device development. It was clear that there is strong commitment to making this public-private partnership succeed.
From NORD’s perspective, the idea of addressing challenges through the application of shared knowledge is clearly a desirable approach and one from which patients are likely to benefit. The new consortium will draw together experts from the FDA, the medical device industry, academia and related organizations, with NORD at the table to serve as the voice of the patient community.
As I stated in my remarks at the announcement today, NORD will be an active participant in working collaboratively with the FDA, the industry and other consortium members to advance regulatory science. We have a long history of working to advance the development of medical devices, including humanitarian use devices for very small (fewer than 4,000) patient populations.
We hope this public-private partnership will serve as a model for additional collaboration. For now, we will take very seriously this opportunity to participate in an initiative aimed at:
- Ensuring that innovative technology is readily available to U.S. patients
- Making the medical device regulatory process more expeditious, transparent and effective
- Reducing the risk and expense of clinical research and
- Reducing the time and cost of medical device development