Medical Device Innovation Consortium

MDIC is not an investment firm. It is a public-private partnership consortium that does not deploy capital, make direct investments, or manage a portfolio. Its budget and funding model are member-supported, and programmatic decisions are driven by its executive leadership and a board composed of industry, government, and patient representatives.

No. The organization allocates no capital to venture funds, does not take equity positions, and does not participate in direct investment rounds. Its work is entirely focused on regulatory science — creating tools and standards that reduce the time, cost, and evidence burden for medical device developers seeking FDA clearance or approval.

MDIC operates as a neutral convener, running projects where FDA reviewers, device manufacturers, and researchers co-develop regulatory science tools. For example, the FDA accepts computational modeling and simulation evidence shaped by MDIC working groups as part of pre-market submissions. The consortium also manages early feasibility study programs that align with the FDA's efforts to bring novel device trials into the U.S. earlier.

The consortium produces frameworks, metrics, and benchmark reports that are designed for practical integration into regulatory filings. These include the Case for Quality's product quality metrics, computational modeling credentialing templates, real-world evidence study designs, and cybersecurity maturity models. Members use these assets to strengthen their interactions with the FDA and payers.

No, and the distinction is baked into its operating model. MDIC explicitly states that it works on science, not policy. It does not lobby Congress or advocate for specific legislation. Instead, it solves pre-competitive technical problems — such as how to validate an AI algorithm across multiple hospital sites — that no single company or the FDA could efficiently solve alone.