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Your device just got FDA clearance. So why isn't anyone using it? In this episode of From Idea to Market, Joe Schwab and a panel of surgeons, engineers, and MedTech leaders explore why regulatory approval is only the beginning — and what it actually takes to earn a place in the operating room.

Clearance tells you a device is safe and effective. It doesn't tell you whether a busy surgeon will change their workflow, whether a procurement committee will approve it, or whether a hospital can absorb it into daily practice. This episode unpacks the gap between permission and performance — the space where most MedTech innovations either earn trust or stall out.

Drawing on Everett Rogers' Diffusion of Innovations theory and recent research on early adoption decision-making in surgery, the conversation examines why clinical evidence alone isn't enough. Guests describe how simplicity, immediate benefit, team dynamics, and peer influence determine whether a technology sticks — and why the intention-behavior gap in surgical practice is wider than most companies expect.

The panel also explores how success is redefined after clearance, moving from trial endpoints to real-world outcomes including patient satisfaction, complication rates, workflow efficiency, and health economics. In the PJI space alone, annual hospital costs are projected to reach $1.85 billion by 2030, giving technologies that move the needle enormous clinical and economic significance.

⏱️ Chapters:
00:00 Introduction and series overview
02:34 Meet the panel
05:47 Why clearance is only the beginning
07:42 Diffusion of innovations in surgery
11:07 Investing in data vs inventory after clearance
16:11 The intention-behavior gap in adoption
18:14 Deliberate rollout and early adopter strategy
20:55 Simplicity as the key to surgical adoption
23:18 Market forces behind technology uptake
26:19 Redefining success outside controlled settings
29:24 PJI economics and the case for innovation
33:19 When innovation becomes the standard of care
36:52 Three lessons from life after clearance

Listen to the AHF Podcast on your preferred platform:
Buzzsprout: https://ahfpodcast.buzzsprout.com
Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487
Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc
LinkedIn: https://www.linkedin.com/showcase/ahf-podcast
YouTube: https://www.youtube.com/@anteriorhipfoundation
Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

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From Idea to Market: Ep 7 - Beyond Clearance