Should You Avoid Being a Medical Device? With Steven Wardell and Joe Schwendt

What's the line for being classified as a medical device? Is it worth it today to be a medical device? What is going on in medtech?

What's the line for being classified as a Medical Device? Is it worth it today to be a medical device? What is going on in medtech? The promise of Medical Devices used to be that it wasn't that hard to provide great clinical value for an unmet medical need with a new device and with an straightforward FDA process you could have a high-growth, high-margin product. But what is the real opportunity today?

In this show we'll cover:

• What are the challenges facing Medical Devices today?
• What are the tradeoffs to avoiding or choosing the medical device pathway?
• What is the real cost difference?
• How does AI come into play?

And we'll answer your questions.

Joe Schwendt is the Founder and CEO of Runway Hero, a boutique consultancy that helps MedTech and Pharma teams build modern medical device software fast, compliant, and inspection-ready. With three decades in regulated digital products, he turns concepts into validated releases with clean documentation, disciplined engineering, and clear business outcomes.

Steven Wardell is the Managing Partner of Wardell Advisors, a consulting firm focused on growth, fundraising, and strategic alternatives for digital health companies. He is the host of DigitalHealth InvestorTalk and the author of The Future of Digital Health. Follow for digital health insights at X.com/StevenWardell.