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, and 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. Members of MDIC share a vision of providing U.S. patients with timely access to high-quality, safe and effective medical devices.
MDIC is a non-profit 501(c)3 organization, governed by a Board of Directors, that represents public and private sectors, and patient advocacy groups. 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. A listing of current board members is included at the end of this document. MDIC works on science, not policy. Participation in MDIC is open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; organizations that promote public health; and organizations with expertise in regulatory science. MDIC has 59 member organizations; approximately one-third are government or not for profit, one-quarter are larger companies with revenue greater than $1B, one-third are companies with revenue less than $1B and one-tenth are pre-revenue companies.
Our Mission: Faster, Safer and more Cost-effective innovation for Patient Benefit
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
We have two primary areas of focus to realize our mission:
- Develop Regulatory Science Tools that can be used to transform the development, assessment and review of new medical technologies for patient benefit in the following priority areas:
- New tools and methods to support clinical trial innovation for therapeutics and diagnostics to improve access, reduce cost and improve safety
- Practical tools that support incorporation of patient preferences and patient engagement into the clinical trial design process to give patients a voice where appropriate
- Apply regulatory grade computational modeling & simulation science to clinical applications
- Quality improvement initiatives to improve patient outcomes beyond product quality
These priority areas were identified based on member input, potential impact on patient benefit, willingness of member organizations to staff projects, project funding and alignment with CDRH strategic priorities. The goal is to develop tools and processes that enable implementation and drive cost-effective innovation. The governance structure is designed to scale and adjust as member resources and funding priorities change. Specifically, the design is modular: each board-approved project has a steering committee that provides oversight and governance and directs work group activity and milestones. FDA has representation on the steering committee and working groups for each project.
- Establish the National Evaluation System for health Technology (NEST) Coordinating Center (CC). In September of 2016 MDIC was awarded a $3M grant by CDRH followed by a $30M commitment over 5 years of MDUFA funding. Our primary priority during the performance period is to establish the CC, develop the governance structure and execute on projects that demonstrate the value of real world evidence to patients, manufacturers, payers and providers. Our work in this area has the potential to redefine how new technologies are developed and evaluated
Accomplishments to Date:
MDIC has made significant progress in a number of priority areas:
- Our most significant accomplishment is the Patient Preference Framework Report. This report has more than 1000 unique downloads and was used to inform FDA draft guidance on incorporating patient preferences into premarket clinical trial designs
- Another important milestone is the completion of a mock submission of a cardiac lead with virtual patients to support reduced clinical trial size. The submission is complete and has been approved. It is an important first step to incorporating modeling and simulation tools into clinical trial designs
- Developed a statistical framework for incorporating prior clinical data to inform clinical trial design; 8 member organizations to date have completed retrospective analysis showing a clinical trial size reduction between 15% and 50%
- MDIC also piloted a process for “regulatory grade” expert review of models for submission to CDRH. This project has real potential for situations where traditional clinical trials are not practical or add undue burden to patients.
- To support adoption of the CDRH Early Feasibility Study program, MDIC has developed a Blueprint report followed by a collaborative initiative with the Transcatheter Cardiovascular Therapeutics (TCT) leadership to address the practical challenges of conducting early feasibility studies in to realize the vision of US patient access of safe and effective medical therapies first in the world.
- Awarded $3M grant from CDRH for the NEST Coordinating Center followed by $30M of MDUFA funding commitment over 5 years to support demonstration of value for the use of real world evidence for premarket approvals and clearances as well as enhanced safety reporting.