Hardware Podcasts

#387: The case for Real World Evidence Studies

Global Medical Device Podcast · 17 Oct 2024 · 29m · Episode 387

What this episode covers

Simon Mason, President of NEST (National Evaluation System for Health Technology), explains how the organization leverages real-world evidence (RWE) to streamline FDA regulatory submissions and accelerate time-to-market for medical device companies. He details NEST's unique governance structure, funded by MDUFA fees, which facilitates collaboration between the FDA, industry stakeholders, and data providers to validate existing data for regulatory use. Mason highlights successful test cases involving Johnson & Johnson and Intuitive Surgical, demonstrating how off-label data from pediatric and robotic surgery applications can support new clearances, significantly reducing clinical trial costs and protecting market share against erosion.

Most relevant to

early-stage companies and large enterprises

Topics

Mentioned

Companies
Johnson & Johnson, Intuitive Surgical, Health Verity
Also
NEST, MDUFA, FDA, MDIC, Greenlight Guru, Rook Quality Systems, Epic

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