CMTP assisted the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in 2010-2011 in exploring a proposal for a public-private partnership (PPP) known as the Medical Device Epidemiology Network (MDEpiNet). The primary goal of MDEpiNet would be to develop innovative methods in the area of medical devices to improve and enhance the understanding of device performance. Through methodological innovation, post-approval studies can be faster, less expensive and simpler, making the evidence more readily available to end users, while also assisting device manufacturers with their regulatory requirements.
By improving and enhancing the understanding of medical device performance, MDEpiNet aims to enable timely and better decision-making about medical devices by patients, providers, the FDA, payers, the medical device industry, and other information end-users. MDEpiNet has the potential to serve as a platform for multi-stakeholder collaboration to help facilitate the identification of key evidence gaps, foster innovative methodological advances, provide funding for projects and follow-on studies, leverage and create access to data sources, serve as a forum for methods standardization, and enable collaboration and sharing of expertise and resources across a diverse range of medical device stakeholders. Ultimately, MDEpiNet aims to change the paradigm of how information about medical devices is utilized throughout the total product life cycle, and to advance methods to study medical devices and procedures involving medical devices.
As of January 2012, the FDA announced that it will fund early initiatives to build MDEpiNet infrastructure at two universities. We anticipate that establishment of a diverse multi-stakeholder MDEpiNet Public Private Partnership will follow the creation of this infrastructure.