In this episode, I had the pleasure of sitting down with Dr. Sandra Waugh Ruggles, a true expert in the MedTech space and an absolute powerhouse when it comes to innovation policy. Sandy walks us through the often-overlooked reality of how long it really takes for a medical device to get from FDA clearance to Medicare coverage—a whopping 5.7 years, on average! We dive into why that delay exists, how it impacts both patients and companies, and what can be done to close that gap.
Listen in to hear Sandy’s fascinating stories and her deep expertise on how we can bring life-changing technologies to those who need them faster.
00:25 The Long Road to Medical Device Approval
01:06 Meet Sandy Ruggles: Innovator and Policy Expert
01:48 From Biotech to MedTech: Sandy's Journey
03:45 Family Influence on Career Path
05:10 Regulatory and Policy Innovation
09:57 The Biodesign Process: From Needs to Insights
19:15 Electrophysiology and Emergency Department Innovations
24:26 Prototyping Challenges and Market Opportunities
25:55 The Journey of the Pacing Wire
27:00 Innovation Policy: An Introduction
27:45 Creativity in Policy Making
30:16 Navigating the Path to Medicare Coverage
32:19 The Valley of Death in MedTech
36:31 Challenges in Medical Device Approval
43:41 Bureaucracy and Innovation
46:50 The Heart of Healthcare
48:38 MedTech Heroes and Closing Thoughts
Follow Shannon and Sandra:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy/
Connect with Sandra:
LinkedIn: https://www.linkedin.com/in/sandrawaughruggles/
