Walnut Hill Medical Joins FDA TAP Program as Strategic Advisor to Accelerate Patient Access to Breakthrough Therapies

DALLAS, June 11, 2025 /PRNewswire/ -- Walnut Hill Medical, a leading healthcare consultancy specializing in market access, reimbursement strategy, and patient access for medical innovations, is proud to announce its selection as an advisor to the U.S. Food and Drug Administration's (FDA) Total Product Life Cycle Advisory Program (TAP). This landmark 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), with the goal of transforming how breakthrough medical devices reach patients.

TAP addresses a persistent gap in the innovation ecosystem: while many medical technologies are clinically promising, they often face delays in reaching patients due to misaligned regulatory, coverage, and reimbursement pathways. TAP is designed to solve this by offering early, proactive, and sustained support to breakthrough-designated medical devices—connecting innovators with FDA experts and external advisors to accelerate development, streamline regulatory review, and align evidence generation with payer expectations.

As a TAP advisor, Walnut Hill Medical will bring deep expertise in reimbursement strategy, market access, and patient access to help companies design smarter, faster commercialization pathways. The firm will guide early planning for coverage, coding, and payment strategies, ensuring 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."

Walnut Hill Medical's participation reinforces its commitment to advancing innovation by helping medical device companies address regulatory, commercial, and policy challenges through collaborative, patient-centered strategies.

About Walnut Hill Medical

Walnut Hill Medical partners with medical device innovators to provide comprehensive patient access services—from benefits verification and prior authorization to data-driven insights on payer behavior. By working directly with providers, payers, and industry stakeholders, Walnut Hill accelerates time-to-treatment and expands access to life-changing therapies.

About the FDA Total Product Life Cycle Advisory Program (TAP)

The Total Product Life Cycle Advisory Program (TAP) is an FDA initiative focused on providing integrated, strategic input throughout the life cycle of medical devices. By leveraging early engagement and continuous collaboration, TAP aims to improve regulatory predictability and support innovation that benefits patients.

For media inquiries or further information, please contact:

Grace Cuillier
Director of Strategy
Walnut Hill Medical
GCuillier@WalnutHillMedical.com

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SOURCE Walnut Hill Medical