The Medical Device Innovation Consortium is a public-private partnership (PPP) whose mission is to improve health through the application of shared knowledge in regulatory science.
The MDIC is the only public-private partnership (PPP) focused exclusively on the strategic needs of the medical device industry. The MDIC is designed to create a collaborative environment where the industry, non-profit organizations, and government can work together to advance pre-competitive medical device research so that the medical device community can keep pace with the needs of the patients in the United States in a more timely manner.
Regulatory science refers to the development and evaluation of new tools, methods, standards and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.
The MDIC has been formed to add value at the intersecting needs of the medical device industry, the FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the U.S.
The MDIC is the first ever public-private partnership (PPP) created with the sole objective of advancing medical device regulatory science. The intent is to be a national 501c(3) organization that operates in partnership with the FDA.
The MDIC will be governed by a Board of Directors that will oversee the MDIC’s subcommittees. Subcommittees will represent industry sectors or technology areas (eg, modeling, interoperability, orthopedics, neurological devices).
The MDIC will pursue several strategies in support of its mission:
The activities and output from the MDIC will:
The MDIC will accept project proposals specifically focused on advancing medical device regulatory science.
After the initial meeting of the MDIC Board of Directors (early in CY13), the first sector subcommittees will be commissioned.
The advantages of conducting research within the MDIC include:
The core operations of the MDIC are funded through contributions from members.
Membership will be offered at several levels based on organization type and, if applicable, annual revenue. Project specific funding will be obtained from companies and foundations as a result of working group development of rigorous project plans.
The MDIC will provide its members with: