Most early-stage founders know they need regulatory help. What they don’t know is that by the time they think they need it, they’re already two years behind. The submission is not the strategy — and confusing the two is one of the most expensive mistakes in medtech.

In this episode, Shaherah Yancy, founder of Research Lifecycle Solutions, joins Dan Mazzucco to talk about what regulatory strategy actually means for early-stage founders. They discuss the five milestones every medtech company must hit, why regulatory is the anchor to your entire commercialization plan, how FDA has become more collaborative when you bring quality questions, and why the founders who win are playing chess while others are playing checkers.

This conversation is for medtech founders and innovators who suspect their regulatory thinking is a checkbox exercise and are ready to find out what it actually should be.

Shaherah Yancy is the founder and CEO of Research Lifecycle Solutions (RLS), an internationally recognized clinical scientist, award-winning regulatory strategist, and global keynote speaker. With over 20 years in life sciences, she has led regulatory, clinical, and commercialization strategies behind hundreds of MedTech and BioTech innovations launched across the U.S., Canada, Europe, China, and Australia. Before founding RLS, Shaherah held leadership roles at Medtronic, Smith + Nephew, and Stryker, where she directed global clinical affairs and market access for Class I–III medical devices, robotics, and enabling technologies. She has been named Best Regulatory Consultant by Consulting Magazine and nominated for Best Regulatory Strategy Consultancy of the Year by MedTech World.

Theme Music: Prelude, composed andperformed by Benjamin Mazzucco, © 2026. Used with permission.