Walnut Hill Medical, a healthcare consultancy specializing in market access and reimbursement strategy, has been selected as an advisor to the U.S. Food and Drug Administration's Total Product Life Cycle Advisory Program (TAP). The announcement, made on June 11, 2025, positions the Dallas-based firm to help accelerate patient access to breakthrough medical devices through the FDA's landmark initiative.
FDA's TAP Program Addresses Innovation Ecosystem Gaps
The TAP program was launched in 2023 by the FDA's Center for Devices and Radiological Health (CDRH) as part of the Medical Device User Fee Amendments (MDUFA V). The initiative was designed to transform how breakthrough medical devices reach patients by addressing a persistent challenge in the innovation ecosystem: while many medical technologies show clinical promise, they often face significant delays in reaching patients due to misaligned regulatory, coverage, and reimbursement pathways.
TAP offers early, proactive, and sustained support specifically to breakthrough-designated medical devices. The program connects innovators with FDA experts and external advisors to accelerate development, streamline regulatory review, and align evidence generation with payer expectations.
Strategic Advisory Role in Market Access
As a TAP advisor, Walnut Hill Medical will contribute deep expertise in reimbursement strategy, market access, and patient access to help companies design more efficient commercialization pathways. The firm will guide early planning for coverage, coding, and payment strategies, ensuring that high-impact devices are not only approved but also accessible to patients who need them most.
"We are honored to contribute to the FDA's TAP Program and support its mission to modernize how innovative devices move from concept to clinical use," said Chris Hanna, CEO at Walnut Hill Medical. "It's not enough to secure regulatory approval—companies must also navigate payer policy, pricing, and access barriers. TAP gives us the platform to help innovators think holistically from day one."
Comprehensive Patient Access Services
Walnut Hill Medical partners with medical device innovators to provide comprehensive patient access services, ranging from benefits verification and prior authorization to data-driven insights on payer behavior. The company works directly with providers, payers, and industry stakeholders to accelerate time-to-treatment and expand access to life-changing therapies.
The firm's participation in the TAP program reinforces its commitment to advancing innovation by helping medical device companies address regulatory, commercial, and policy challenges through collaborative, patient-centered strategies.
Program's Integrated Approach to Device Development
The Total Product Life Cycle Advisory Program represents an FDA initiative focused on providing integrated, strategic input throughout the entire life cycle of medical devices. By leveraging early engagement and continuous collaboration, TAP aims to improve regulatory predictability and support innovation that ultimately benefits patients.
The program's approach recognizes that successful medical device innovation requires coordination across multiple stakeholders and regulatory pathways, from initial development through post-market surveillance and reimbursement decisions.
