Essay · Commercialization
FDA clearance is the most overrated milestone in MedTech, and the proof sits inside almost every cath lab in the country · Juan Vegarra
FDA clearance is the most overrated milestone in MedTech, and the clearest proof is sitting inside almost every cath lab in the country.
Consider intracoronary imaging. The term sounds technical, but the idea is simple. Instead of judging a coronary artery from a flat X-ray shadow, you thread a miniature ultrasound or light-based camera inside the vessel and look at the wall, the blockage, and the stent from within. The two common versions are IVUS, which uses sound, and OCT, which uses light. It is one of the most heavily studied tools in interventional cardiology. A decade of trials has pushed in the same direction. In 2024, European cardiology guidelines handed it their strongest possible endorsement, a Class IA recommendation, for the most complex procedures. The worldwide market for it runs north of four billion dollars a year.
And after all of that, it is used in only about a third to forty percent of the cases where the guidelines say it belongs.
That number deserves a long pause, because it quietly demolishes the story this industry tells itself about how innovation works. The story is comforting and linear. Build something that genuinely works. Prove it in trials. Earn the clearance. Watch adoption follow. Intracoronary imaging did every step of that, at the highest level the field can confer, and most operators still default to the older approach on most days.
The gap is not a medical failure. It is a commercial one. And once you learn to see it here, you cannot stop seeing it everywhere in this business.
Here is what an FDA clearance actually certifies: that a device is reasonably safe and does what its maker claims. That is the whole of it. It is a necessary permission slip, and it is also the most predictable, most controllable, and frankly cheapest milestone in the entire life of a medical technology.
What clearance does not touch is the only thing that decides whether a company survives, which is behavior change. A busy operator has to be persuaded to alter a routine that already works well enough. The hospital has to be convinced to spend money it had earmarked for something else. And somewhere in the background, a payer has to agree to cover the result. The FDA weighs in on none of this, and none of it is settled the day the approval letter arrives. Treating clearance as the finish line is like treating a driver's license as the road trip. It gets you legally permitted to begin. The distance still has to be driven.
The second comfortable assumption is that strong data forces its own adoption. If the trials are good enough, surely the behavior follows.
It does not, and intracoronary imaging is again the proof. Even the evidence refuses to resolve into a clean mandate. A series of trials run largely in East Asian centers, including RENOVATE-COMPLEX-PCI and OCTIVUS, reported meaningful benefit from imaging guidance. More recent Western trials, including IVUS-CHIP and OPTIMAL, both published this year, did not separate from plain angiography, the standard dye-and-X-ray picture, on their primary endpoints. The data is not weak. It is genuinely mixed, shaped by who was enrolled, how good the comparison already was, and whether the picture actually changed what the operator did next.
But notice the deeper point. A Class IA recommendation already exists, built on the larger body of work, and adoption still sits at a third to forty percent. A guideline is a recommendation, not an entry on anyone's calendar. It changes what gets said from the podium at the big meetings. It does very little about the schedule pressure in a real lab, where every extra imaging run adds minutes to a case, and where minutes are the currency that decides how many patients get treated that day. Evidence sets the ceiling on what is possible. Habit, workflow, and time decide what actually happens beneath it.
This is the fact founders and engineers underweight more than any other, and it sits at the center of the whole problem.
The cardiologist at the table may want the imaging tool. The cardiologist does not write the check. That decision lives with a hospital value-analysis committee, the cross-functional group that vets new purchases, and with a hospital profit and loss statement that has to balance at year end. Those people are reading a completely different spreadsheet than the enthusiast in the procedure room. The enthusiast is reading clinical benefit. The committee is reading capital cost, per-case disposable cost, training time, throughput, and how all of it trades against the ten other things the hospital could buy instead.
It gets harder, because most imaging platforms follow a razor-and-razorblade structure. There is an expensive console, the capital equipment that lives in the lab, and there are single-use catheters consumed on every case. The console is a one-time brawl with the budget. The disposables are a small tax on every procedure, forever. A device can win every clinical argument in the room and still lose the meeting down the hall, because the people in that meeting are solving a different equation than the one the science answered.
There is one more gate, and it is the one that turns a cleared, evidence-backed, clinically loved device into a commercial non-event: payment.
A technology that is not reimbursed is not a product. It is a favor the hospital performs at its own expense. The machinery that decides payment, the procedure codes, the category a hospital's payment falls into, the supplemental payments that occasionally bridge the gap for genuinely new technology, moves on its own slow timeline, and that timeline frequently lags the FDA by years. The date a device is cleared and the date a hospital can actually get paid to use it are often far apart. The second date is the one that matters. It is the real launch date, and almost nobody outside the commercial function is even tracking it.
If you want to know what a sophisticated buyer believes is truly scarce in this industry, watch where the largest checks go.
In January, Boston Scientific agreed to acquire Penumbra for roughly fourteen and a half billion dollars. A company with that engineering bench could build a great deal on its own. What it cannot quickly build is a deep, trusted position in a set of clinical channels, the relationships, the contracts, the install base, the commercial reach into the room where care happens. So it bought them. Distribution, it turns out, is far harder to manufacture than a catheter. The technology is replicable. The path to the patient is not.
That is the quiet truth underneath all of it. The device gets you a ticket to the game. Everything that decides whether you win, the economic case for the buyer who is not the user, the workflow fit, the payment pathway, the channel, gets built around the device after the science is done. The product is the beginning of a company, not the company itself.
None of this is an argument against great engineering. It is an argument against mistaking great engineering for a finished job. I have watched the best technology in a category lose to plainly inferior technology with a better commercial architecture more times than I can count, and most people who have spent a career in this business carry the same scars.
So the next time a device earns its clearance and the room erupts, it is worth sitting with a quieter question while everyone else celebrates. The science is settled. Who, exactly, is going to change their Tuesday for it, and what will it take to make that worth their while?
SOURCES
2024 ESC Guidelines for the Management of Chronic Coronary Syndromes. European Heart Journal. 2024. Class IA recommendation for intracoronary imaging (IVUS or OCT) in anatomically complex PCI.
IVUS-CHIP. Intravascular Ultrasound-Guided or Angiography-Guided Complex High-Risk PCI. New England Journal of Medicine. 2026. DOI: 10.1056/NEJMoa2601521.
OPTIMAL investigators. IVUS-Guided versus Angiography-Guided PCI in Unprotected Left Main Coronary Disease. New England Journal of Medicine. 2026. DOI: 10.1056/NEJMoa2600440.
Industry market estimate: coronary intravascular imaging market exceeding $4 billion annually, with IVUS and OCT penetration at 30 to 40 percent of eligible procedures. Conavi Medical Corp. press materials, April 2026.
Boston Scientific Corporation. Definitive agreement to acquire Penumbra, Inc., approximately $14.5 billion enterprise value. Press release and Form 8-K, January 15, 2026.
Juan Vegarra is the author of An Outsider's Playbook (forthcoming). The views here are his own. More from the Notebook · Continue the conversation