TAP Expansion, RWE Momentum, and FDA Funding Pressures
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Kristy Katzenmeyer-Pleuss, PhD (KP Medical Device Consulting) to break down key FDA updates and what they mean for MedTech companies navigating regulatory strategy in 2026.
The episode covers the De Novo clearance of neuropacs™, a Parkinsonian diagnostic tool using MRI data to support clinical decision-making, and a new PMA for the NEXUS® Aortic Arch Stent Graft System. The discussion then shifts to broader regulatory trends, including the expansion of the FDA’s Total Product Life Cycle Advisory Program (TAP) and the agency’s increasing use of real-world evidence (RWE), highlighted by the release of 73 case examples across 510(k), De Novo, and PMA pathways.
The team also explores the growing tension between investor expectations and regulatory readiness. Startups face pressure to engage with the FDA earlier than optimal, often tying funding milestones to regulatory interactions. This dynamic raises strategic risks that can impact long-term success.
Additional topics include:
The FDA’s READI Home Innovation Challenge and the shift toward home-based care models
The launch of White Oak 66, a venture firm led by former FDA leaders aiming to align early-stage funding with regulatory strategy
Differences between EU MDR data generation and U.S. regulatory expectations
Ongoing staffing changes at the FDA and their potential impact on review timelines and submission quality
Throughout the episode, the group shares practical insights drawn from their FDA and consulting experience, offering a candid look at where current programs are working—and where gaps remain.
If you're working in regulatory affairs, clinical strategy, or early-stage MedTech development, this episode provides timely perspective on how to align your approach with evolving FDA expectations.
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