Medical Device Innovation Consortium

The Medical Device Innovation Consortium (MDIC) is the only public-private partnership specifically developed to collaborate with government and industry stakeholders to advance solutions that promote patient access to innovative medical technologies. MDIC has established several initiatives and programs to achieve its mission. The medical extended reality device workgroup focuses on developing an augmented/virtual reality implementation roadmap. The Advanced Manufacturing Clearing House initiative encourages the adoption of advanced technology throughout the total product life cycle. MDIC’s Clinical Diagnostics program aims to enhance diagnostic testing and product development using novel regulatory science approaches. The Case for Quality Collaborative Community elevates the focus of medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety. The External Evidence Methods program seeks to establish a more predictable pathway for using external evidence methods, such as real-world data and computational modeling, to support regulatory medical device decisions. The Science of Patient Input initiative collaborates to improve the inclusion of patient perspectives in the development, pre-market approval, and post-market evaluation of medical devices. MDIC’s Digital Health initiative addresses the convergence of connectivity, information, and software in medical devices, including areas like Software as a Medical Device and patient-generated data. The Cybersecurity program identifies priorities for ensuring the safety and effectiveness of medical devices across their lifecycle. Lastly, the Health Economics and Patient Value initiative promotes predictability of evidentiary processes, improves pathways for coverage, and ensures patient perspectives are considered.