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.