Best Practices for Implementing Design Contro...

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere ...  Show more

The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined the podcast. Driven by factors like the rise of AI, economic volatility, and post-pandemic shifts, the dynamic has swung from a "war for tal ...  Show more

Did you know that all people with blue eyes are related to each other? That is just one of the fascinating things we explore as I begin this episode with a look at how your eyes work and how they help you navigate your world.  http://www.buzzfeed.com/acuvue/impossibly-cool-facts-y ...  Show more

WEGO Health is on a mission-driven company connecting healthcare with the experience, skills, and insights of Patient Leaders. They are the world’s largest network of Patient Leaders, working across virtually all health conditions and topics. The WeGo Health network collaborates ...  Show more

Pediatric airway surgeon Dr. Michael Rutter and I discuss risk-taking and effective market analysis in entrepreneurship. In the operating room, Dr. Rutter cultivates a congenial OR environment and often seeks ideas from other team members with different areas of expertise. These ...  Show more

Today's guest is Dr. Nele Jessel, Chief Medical Officer at Athenahealth. Athenahealth is one of the leading U.S. providers of network-enabled services for healthcare and point-of-care mobile apps. She joins us on the program to talk about the biggest challenges facing healthca ...