The floor doesn't open with a bang.
It opens quietly, with a press release from a journal you've been watching for two years.
That's the Nyiragongo image I keep returning to when medical device's evidence pattern runs its course: not eruption, not drama, the lava lake drains. The landscape above looks much the same as it did before. The devastation is underground, and it takes time to register at the surface.
The commercial consequence arrives faster.
Vertebroplasty is the most documented version. By 2009, the procedure had strong observational support: 75 to 95 per cent pain relief rates, established reimbursement, and a cultivated KOL network. Then the NEJM published two sham-controlled trials simultaneously.
Insurance reimbursement volumes contracted. The commercial infrastructure built for a broad indication had to be renegotiated almost from scratch. The procedure survived. The team that had been selling it didn't, not in the same configuration.
Renal denervation moved faster and fell further: fifteen to twenty thousand procedures in Europe in four years. Medtronic had built the market. Physician training, procedure protocols, reimbursement arguments, a pipeline full of competitors watching and building their own programmes.
SYMPLICITY HTN-3 was reported in early 2014. The announcement shocked the field. Medtronic indicated asset writedowns were likely. The competitors stopped.
The commercial infrastructure, which had been optimised for a world where the trial was about to confirm, was no longer useful.
Metal-on-metal hip resurfacing added legal consequences to the same structural failure. Impella, post-ACC 2026, is now negotiating its narrower version.
Here is what these cases share, and it's not the science.
The commercial engine built to take market share before the evidence matures is rarely the right engine to defend the indication once it narrows. The pioneer who sells on physician enthusiasm and mechanism-of-action arguments is optimised for ambiguity, momentum, and relationship-building in the absence of definitive data.
Leaders who manage narrowed indications, rebuild reimbursement positioning, and clinical relationships after difficult news have a different professional profile and behavioural style. Medical device companies routinely assume the person who built the market can rebuild it on new terms.
The pattern says otherwise.
This is not about commercial ambition being wrong. Early investment sometimes funds the very trials that clarify the indication. Renal denervation has returned, with improved technology and positive data in specific populations. The device didn't disappear.
It was rebuilt on a narrower evidence base, by a commercial team with different competencies than the one that built the original market.
The question isn't what to do when the floor opens.
It's what you wrote eighteen months before.
Because by the time the trial reports, the hiring decision has already happened. The commercial team has been selected, trained, and deployed for a world where the evidence was about to confirm. If the brief didn't anticipate the possibility of a narrower indication, the team it produced won't survive one.
Most briefs don't.
Most briefs are written for the world that exists, not the one that might.