If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance.
And if you're anything like the guests on today's podcast, you've probably gone through a lot of trial and error trying to implementing them.
Wouldn't it be nice if some industry vets were willing to sharin ... Show More
Jul 21
#416: Unpacking Common FDA Compliance Gaps: Pre-Market vs. Post-Market Realities
In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns. They delve into the nuances of software changes, design creep, and off-label market ... Show More
49m 29s
Jun 2018
540: How WeGo Health Are Uniting Patient Leaders and Experts
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
25m 23s
Apr 2024
The Dean of Stanford Medical School on How AI Is Shaping The Future of Health Precision
This week, I am joined by Dr. Lloyd Minor, the Carl and Elizabeth Naumann Dean of the Stanford University School of Medicine and Vice President for Medical Affairs at Stanford University. Dean Minor talks about the transformative potential of AI in healthcare delivery, research, ... Show More
1h 41m
Oct 2019
Disrupting the Healthcare Industry with Ali Diab, co-founder, and CEO of Collective Health
Navigating the healthcare landscape as a patient or caregiver has never been more challenging. Ali Diab, co-founder, and CEO of Collective Health, has experienced this first hand and it was those challenges that motivated him to improve the quality and cost of company-sponsored h ... Show More
58m 2s
Oct 2023
Ep. 134 The Tympa Health Journey: From Clinical Challenge to Tech Solution with Dr. Krishan Ramdoo
In this episode, Dr. Gopi Shah interviews Dr. Krishan Ramdoo, CEO and founder of TympaHealth, a London-based startup that has developed an all-in-one device for hearing health assessment which incorporates otoscopy and microsuction functionalities. --- SHOW NOTES Krishan is an EN ... Show More
42m 12s