Public-private partnership coordinating center for National Evaluation System

Medical Device Innovation Consortium, Arlington VA

Investigators

Abstract

The Medical Device Innovation Consortium (MDIC), a 501(c)3 Public-Private Partnership and governance structure is best suited to bring together device manufacturers, payers, regulatory agencies, patient groups, physicians, providers and other relevant stakeholders to develop a National Medical Device Evaluation System (NMDES) Coordinating Center (CC). Our approach is to develop a CC that oversees the development and operations of a collective modernized medical device surveillance program via decentralized data evaluation systems. We leverage and develop standards for data procurement, signal detection, data processing, and reporting. The CC and governance system will be anchored on diverse stakeholder inclusion, highest ethical standards, patient-centered outcomes, and a business culture of efficiency and accountability to create the foundational principles of trust, transparency, scalability, sustainability and accountability. AIM 1: Establish a governance committee of the key stakeholders charged with inaugurating a CC for the NMDES that is inclusive, patient-focused, and anchored in equity and transparency. AIM 2: Establish scope, strategy (decentralization, stakeholder engagement, independence from bias, open science and data sharing, objective prioritization), structure (primary data processes and secondary data and results dissemination), standards (data, methods, reporting, and data access, audit and certification), in a decentralized and federated NMDES. AIM 3: Guarantee an inclusive pathway for competitive innovation and continual modernization through decentralized data warehousing and integration. AIM 4: Conduct pilot projects to develop, verify and operationalize methods of evidence generation and data use, demonstrate scalability across healthcare systems and device types and manufactures, and prove out principles of NMDES sustainability. Our first Phase 1 patient focused pilots are centered on high-risk category devices that require tracking and EHR data from hospital systems that use modern means of data collection. MDIC's letters of support from strategic patient and industry partners indicate a commitment to these pilots to establish state-of-the-art safety surveillance methods for medical technologies of public health importance. Phase 2 pilots will establish sustainability of the NMDES to the broader medical technology ecosystem. MDIC will establish the NMDES CC and create a sustainability plan for continued operations. This will allow the use of real-world data in an efficient manner to quickly identify new safety problems for devices on the market and optimally and appropriately rely on real-world evidence to support product approvals of public health importance, to potentially shift premarket data collection to the postmarket setting, and to meet postmarket data collection commitments through a modern system that leverage electronic health information generated in the clinical and home setting.