How to Bring a Medical Device to Market (Why 90% of Products FAIL)

In this episode of the Leadership Exchange Podcast, host Tracy Lee sits down with pediatric urologist and medical device innovation consultant, Dr. Emily Blum. They explore the complex world of medical device development—from identifying real clinical needs to navigating FDA regulations, market fit, and reimbursement challenges. Emily shares insights on why 90% of medical devices fail, the importance of customer discovery, and the surprising role of culture change in healthcare innovation. They also discuss the rise of continuous glucose monitors, the evolution of wearable health tech, and what startups need to consider before bringing a product to market.Key Takeaways from This Episode:- Why Most Medical Devices Fail – Around 90% of medical devices never make it to market, often because startups don’t conduct enough customer discovery. Many innovators build solutions for problems that don’t truly exist or fail to consider how real-world workflows impact adoption.- Regulatory and Reimbursement Challenges – Getting FDA approval is just one hurdle; securing reimbursement from insurers (especially CMS) is often even harder. Many devices fail commercially despite regulatory clearance because they lack a viable payment pathway.- Technology Isn’t Always the Answer – Not all healthcare problems require a new device or software solution. Sometimes, the real issue is a cultural or workflow challenge within hospitals. Understanding the root problem is crucial before jumping to a tech-based solution.- Wearable Health Tech and FDA Oversight – Devices like the Owlet baby monitor and Apple Watch illustrate how regulatory classification impacts product design and claims. Whether a device is considered a “wellness” product or a regulated medical device depends on the claims it makes, influencing its market potential and legal requirements.

Chapters

0:00 Intro & The Challenge of Customer Discovery

0:27 Guest Introduction: Emily, Pediatric Urologist & Innovator

1:00 Medical Device Innovation & Market Success

2:22 The High Failure Rate of Medical Devices

3:49 Why Customer Discovery is Critical

4:11 A Urology Startup’s Misguided Innovation Story

5:07 Expanding Your Network for Better Insights

7:02 The Role of Epic in Healthcare Innovation

9:00 Technology vs. Culture Change in Healthcare

12:22 What Counts as a Medical Device?

15:02 FDA Regulations & Wellness Devices

16:59 Medical Device Development: Five Key Pillars

19:28 The Importance of Reimbursement Strategy

21:19 Continuous Glucose Monitors & Adoption Challenges

22:24 The Rise of CGMs in Consumer Health

23:25 Blood Sugar, Stress, and Behavioral Insights

24:02 Where to Find Emily & Closing RemarksFollow Dr. Emily Blum on Linkedin: https://www.linkedin.com/in/emilyblummd/Sponsored by This Dot: thisdot.co