Mission & Purpose

Faster, safer, and more cost-effective innovation for patient benefit.

The Medical Device Innovation Consortium (MDIC) is the first-ever public-private partnership created with the sole objective of advancing medical device regulatory science for patient benefit. Formed in late 2012, MDIC brings together representatives of the FDA, NIH, CMS, industry, non-profits, and patient organizations to improve the processes for development, assessment, and review of new medical technologies. Our work is unique and complementary to trade associations such as AdvaMed and MDMA.

Our Mission

Medical Device Innovation Consortium (MDIC), through its public-private partnership, aims to accelerate and improve patient access to innovative, high-quality, safe, and cost-effective medical technologies.

Members of MDIC share a vision of a world with timely access to safe and cost-effective medical innovations to improve patients’ lives.

Our board includes the director of CDRH, the director of Coverage and Analysis at CMS, executives representing patient organizations, non-profits, and industry.

MDIC is the first-ever public-private partnership (PPP) created with the sole objective of advancing medical device regulatory science.

We are a nonprofit 501(c)3 organization that operates in partnership with the FDA to improve the medical technology environment.

Participation in MDIC is open to representatives of organizations that are substantially involved in medical and/or medical device:

Research
Development
Treatment
Education

Our members are also involved in the promotion of public health or have expertise in regulatory science.

MDIC works on science, not policy.

Our work improves patient access and safety while reducing costs to the healthcare system. We work on what is essential to all stakeholders. We are helping to re-engineer the tools for innovation and regulatory assessments to address the unsustainable cost trajectory of medical technology innovation

MDIC has been designed to pursue several strategies to support its mission:

Create a forum for collaboration and dialogue, working within a flexible governance structure to encourage broad participation from medical device industry stakeholders, including nonprofits, industry, and government
Make strategic investments in regulatory science, utilizing working groups to identify and prioritize key issues and to request, evaluate, and implement project proposals that support MDIC’s mission
Provide tools to drive cost-effective innovation, emphasizing education, and the development of new methods and approaches with well-documented data and details to enable implementation

The activities and output from MDIC will:

Ensure that innovative technology is readily available to U.S. patients
Provide industry and government with methods and tools that may be used to expedite medical device development and the regulatory process
Reduce the risk and expense of clinical research
Reduce the time and cost of medical device development

Regulatory Science

Regulatory science refers to the development and evaluation of new:

Tools
Methods
Standards
Applied science

To support a better understanding and improved evaluation of:

Product safety
Quality
Effectiveness
Manufacturing

Throughout the product lifecycle.

Improving Health

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 United States.

Interested in MDIC membership?

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Current as of November 23, 2020