ย New Release โ $49.95ย ย
Most medical device companies
fail after clearance.
Here's why โ and what to do instead.ย
Built to Exit is the honest guide for medical device innovators who want to change lives, build a company that gets adopted โ and one day sell it for what it's worth.
Instant PDF download ย ยทย 11 chapters ย ยทย 50-Question Clarity Checklist included
FDA clearance is the beginning of the hard part โ not the end of it.
Most medical device founders spend years and millions on development and clinical trials. Then they get cleared โ and discover that no hospital will buy it, no payer will cover it, and no acquirer sees the value. Not because the device doesn't work. Because nobody built a commercialization strategy before they needed one.
~90%
of medical device startups never achieve commercial scale
4
customers to align โ physician, hospital, payer, and patient. Most companies design for one.
$0
reimbursement without a coverage policy โ regardless of FDA clearance status
"Clarity of purpose creates clarity of strategy."
โ CHRIS HANNA, BUILT TO EXIT
WHAT THIS GUIDE IS
The commercialization framework they don't teach in engineering school โ or business school.
Built to Exit is a practitioner's guide to medical device commercialization. Not theory. Not academic frameworks. The actual path a device travels โ from concept to covered procedure to strategic acquisition โ written by someone who has been in those rooms.
Chris Hanna has trained hundreds of device reps, billers, coders, and hospital teams across cardiac, neuromodulation, vascular, implantables, wearables, and diagnostics. He's watched devices fail commercially that had no business failing clinically. He wrote this guide so you don't make the same mistakes.
This isn't a motivation book. It's a strategy guide โ with a 50-question pre-development clarity checklist, a 90-day action plan, a 40+ term glossary, and five parts that walk you from your origin story to your exit check.
WHAT'S INSIDE
Five Parts. Eleven Chapters. One Clear Path.
Every chapter covers what actually happens in the field โ not what's supposed to happen in a perfect world.
PART 1
The Spark โ Before the Science, There Was a Story
- โ Chapter 1: Your Origin Story
- โย Chapter 2: The Vision โ The Exit You Haven't Admitted Yet
PART 1
The Reality Check โ Before You Spend Another Dollar
- โย Chapter 3: The Graveyard Nobody Talks About
- โย Chapter 4: The Pre-Development Clarity Checklist (50 Questions)
- โย Chapter 5: The Reimbursement Reality Check
PART 1
The Roadmap โ How Devices Actually Get to Market
- โย Chapter 6: Navigating the FDA
- โย Chapter 7: Building Your Clinical Case
- โย Chapter 8: Cracking the Reimbursement Code
- โย Chapter 9: Getting Into Hospitals, ASCs, and Physician Offices
PART 1
The Exit โ Building to Be Bought
- โย Chapter 10: Thinking Like an Acquirer from Day 1
- โย Chapter 11: The Road to the Deal
PART 1
They Did It โ Real Stories from the Field
- โย Three composite case studies drawn from real device commercialization journeys
BACK MATTER
The Tools You Keep Coming Back To
- 90-Day Clarity Action Plan
- What Comes Next (your roadmap forward)
- Full Glossary โ 40+ terms defined
WHAT YOU WALK AWAY WITH
Not just reading material. Working tools.
50-Question Pre-Development Clarity Checklist
The questions every device innovator should be able to answer before they spend their next dollar. Covers indication, reimbursement, clinical evidence, market access, and exit strategy. If you can't answer these, you're not ready to build.
90-Day Clarity Action Plan
A structured plan to move from where you are to where you need to be โ broken into three 30-day phases. Designed for innovators who are early-stage and need a framework, not just inspiration.
40+ Term Industry Glossary
510(k), De Novo, PMA, NCD, LCD, CPT Category III, DRG, ASP, prior auth โ defined in plain language by someone who has used them in real conversations with real payers. No Wikipedia. Ever.
ABOUT THE AUTHOR
Chris Hanna has been in those rooms. Now he's telling you what happened.
Chris Hanna is the founder of Walnut Hill Medical and WHM Academy โ and has spent 20+ years inside the medical device industry as a strategist, trainer, and practitioner. He's trained hundreds of device reps, billers, coders, and hospital teams across cardiac, neuromodulation, vascular, implantable therapies, wearables, and diagnostics.
He's seen what works. He's seen what kills companies that should have survived. And he built WHM Academy because the industry needs educators who have actually been in the payer's office, in the OR, and at the negotiating table โ not just in the classroom.
- โย 20+ years inside medtech commercialization โ not consulting from the outside
- โย Trained reps, billers, coders, and hospital teams across 8+ device categories
- โย Built reimbursement strategies for real devices with real payers
- โFounded Walnut Hill Medical and WHM Academy
- โConference speaker and curriculum developer