- Explore More MDIC Sites:
- NESTcc
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- Annual Public Forum
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 advance regulatory science in the medical device industry. MDIC will coordinate the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.
Members of MDIC share a vision of providing U.S. patients with timely access to high-quality, safe and effective medical devices.
Our board includes the director of CDRH, the director of Coverage and Analysis at CMS, C-level 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
That are involved in the promotion of public health; or that 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 important 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.
