MEDpiNET

Duke University, Durham NC

Investigators

Abstract

The MDEpiNet PPP construct promotes a critical step forward for regulatory science, to facilitate both medical device safety surveillance and innovation. Within this construct a number of traditional research and development (R&D) boundaries can be recognized as barriers to both the quality and efficiency of device evaluation and surveillance. In particular boundaries that inhibit informative data pooling (data silos, differing nomenclature, case report forms and endpoint definitions), that unnecessarily partition information gathered over the total product life cycle (pre-market vs. post-market), and that fragment information across international borders, all constitute barriers to the accrual of device-related knowledge, especially with regard to safety information. All of these areas thus provide important targets for efforts that support a higher quality, more seamless and global approach to device registration and surveillance. Pre-competitive collaboration across stakeholders in conjunction with regulatory and other governmental authorities in a transparent public-private partnership (PPP) promotes an ecosystem approach well fitted to both the conceptual and pragmatic transformation of these barriers. Tools such as national and international electronic registries, consensus definitions applied within such electronic infrastructure, statistical methodologies suited to such data sources and actual device evaluation proof of concept programs or other related research projects with deliverables that enhance regulatory science as applied to human clinical trials are well fit to engineer this transformation. This proposal will address the strategy, scale, scope, resources, organizational structure, deliverables and timelines to develop and support systems to facilitate a in-depth understanding of medical device use and associated health outcomes through the Medical Device Epidemiology Network (MDEpiNET) initiative.