Hardware Podcasts

#374: Clinical Evidence - The Key to Market Adoption

Global Medical Device Podcast · 25 Jun 2024 · 47m · Episode 374

What this episode covers

Shaherah Yancy, CEO of Research Lifecycle Solutions and former executive at Medtronic, Stryker, and Smith & Nephew, explains why robust clinical and regulatory strategies are critical for MedTech companies to secure funding and achieve market adoption. She argues that while market access via 510(k) is a milestone, true success requires generating clinical evidence that demonstrates superiority over the standard of care to drive surgeon adoption and payer reimbursement. Yancy advises early-stage founders to design comprehensive studies with 'smart endpoints' that capture economic and workflow benefits, and to use limited market releases to gather real-world evidence for novel technologies.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru Clinical, Research Lifecycle Solutions, Medtronic, Stryker, Smith & Nephew
Also
510(k), PMA, FDA

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