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.
Focused on the Medical Device Industry
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.
Focused on Regulatory Science
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.
Focused on Improving Health
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.
MDIC Members
About Us
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.
- CDRH and LifeScience Alley, Inc. (LSA), a Minnesota trade association, executed a Memorandum of Understanding in December 2011 to, in part, work together on establishing research collaborations in regulatory science. LSA showed a strong commitment to this objective by filing Articles of Incorporation with the State of Minnesota in August 2012 to create an entity focused on advancing medical device regulatory science.
- Membership and participation in the MDIC will be open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or who have expertise in regulatory science.
Governance Structure
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).
- Each subcommittee will be responsible for establishing working groups chartered with identifying key issues affecting their industry segment.
- The working groups will bring forward project plans for prioritization.
What We Do
Strategies
The MDIC will pursue several strategies in support of its mission:
- Create a forum for collaboration and dialogue, working within a flexible governance structure to encourage broad participation from the medical device industry stakeholders, including non-profits, 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 the 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.
Value
The activities and output from the MDIC will:
- Ensure innovative technology is readily available to U.S. patients
- Provide industry and government with methods and tools that can 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
Projects
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 subcommittees will organize working groups to develop rigorous project plans for prioritized topics.
- The subcommittees will work to find resources necessary to support the selected project plans.
The advantages of conducting research within the MDIC include:
- Share best practices across the entire medical device community, including but not limited to government, academia, industry, and non-profits.
- Exposure to a range of perspectives representing multiple constituents which can ensure more robust project development and data interpretation.
- A mechanism for sharing the expense of research in the regulatory science, non-competitive domain.
Join
The core operations of the MDIC are funded through contributions from members.
- Pricing for annual membership is determined based upon the operating expenses for the MDIC.
- The goal is to keep the membership low enough to encourage broad, cross-industry participation while still meeting the operational needs of the organization.
- It is anticipated that as the membership base is increased, there is the potential that the dues per member will decrease.
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.
Benefits of Membership
The MDIC will provide its members with:
- A process for identifying, documenting, prioritizing and removing issues affecting the industry.
- Processes, policies, support staff and pooled project funding to enable efficient regulatory science research in areas of strategic importance to the medical device community.
- Educational forums in which to learn about the evolving regulatory science process, new tools, standards and test methods.
- Searchable databases and links to relevant reports and methods.
- Regular updates on the status of the MDIC’s activities and opportunities for involvement.
Contact Us
To receive further information and to discuss next steps and membership details, please contact:
Dale Wahlstrom
CEO of LifeScience Alley
952-542-3077
dwahlstrom@biobusinessalliance.org
News
Press Releases
- FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies
- LifeScience Alley Launches Medical Device Innovation Consortium