MDIC to Host Innovations in Evidence Summit Focused on RWE in MedTech 

The Summit will feature FDA’s Dr. Michelle Tarver in a fireside chat keynote with CMS’s Dr. Dora Hughes, with a particular focus on the divergent expectations of the FDA and CMS regarding approval and coverage 

WASHINGTON, DC — April 21, 2026 — The Medical Device Innovation Consortium (MDIC), a unique public-private partnership in which FDA, CMS, and NIH work alongside medical device stakeholders to accelerate patient access to innovative technologies, today announced the agenda for their Innovations in Evidence Summit, to be held in Hyattsville, MD on May 5-6, 2026.   

The summit will build on MDIC’s role as a convenor in the medical device space, bringing together government agencies, device manufacturers, and patient advocacy groups to collaborate on the regulatory process and deliver science-backed resources that break down barriers to innovation and patient access. Sessions will include: 

• A fireside chat keynote with Dr. Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health, and Dr. Dora Hughes, Chief Medical Officer and Director within CMS’s Center for Clinical Standards and Quality, in conversation with MDIC President Andy Fish. 

• Case spotlights focused on medical devices which have recently gained regulatory approval exclusively through the use of real-world evidence, guided by the NEST framework. 

• A deep dive into NEST’s new evaluation tool for real-world data sources. 

• Informational discussions on the role of and best practices for real-world evidence in the regulatory approval process.

A key focus at the Summit will be the real-world evidence advancements and standards advocated for by NEST (National Evaluation System for health Technology). NEST works to transform how real-world evidence is used to catalyze medical device innovation from source to regulatory submission to quality assurance.  

“Given the pace of medical innovation, every stakeholder requires a clear understanding of the role and power of real-world evidence to address quality manufacturing, inform regulatory and coverage decisions and help answer questions about our new era of digitally enabled devices,” said MDIC President Andrew Fish. “MDIC provides a trusted, non-competitive space where all stakeholders solve ecosystem problems together through collaboration, and the Summit is an extension of that.” 

Certain sessions will spotlight medical devices which used the NEST framework to achieve regulatory approval exclusively through use of real-world evidence, digging into the strategies that shaped their successful submissions. 

“From the beginning, NEST has been focused on generating better evidence for medical device evaluation and regulatory decision-making,” MDIC Chief Enterprise Officer and NEST President Simon Mason said. “At the summit, we’re looking forward to sharing new tools that will expand that scope and streamline the identification of regulatory-grade RWE for all stakeholders.” 

About MDIC
The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together FDA, CMS, and other agencies with medical device manufacturers, clinicians, and patients to advance the science behind device innovation, manufacturing, regulation and coverage. Working across three core areas — Quality, Evidence, and Digital Health — MDIC develops research, toolkits and actionable frameworks that help manufacturers navigate regulatory approval, maintain the highest quality standards, and build the evidence base payers need to make coverage decisions. MDIC demonstrates that when regulators, payers, patients and industry solve problems together, innovation accelerates and patients benefit. For more information, visit mdic.org. 

About NEST (National Evaluation System for health Technology)
In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology (NEST). NEST is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. NEST combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design™. For more information on NEST, please visit nestcc.org or connect with us on LinkedIn.

Press Contact: mdic@crosscutstrategies.com