Stage does not protect you
What changes with maturity is the shape of the problem, not whether you have one
Two companies in the same breakout last week. One was eighteen months old. The other was several years past FDA clearance, with a deep publication record, a completed pivotal study, and an active randomized trial.
I expected the gap between them to be knowledge. The younger one would not yet know what it did not know, and the older one would. That was half right, and the half I had wrong is the more useful half.
The younger founder did not know which questions to ask. At the end of her twenty minutes she said so, plainly: “it’s really good to know what questions I should be asking at this stage.” Correct answer at eighteen months, and a survivable position, because the questions are findable and she was already looking.
The later-stage CEO knew exactly which questions to ask. He opened by naming them himself. He knew the market he had won and the larger one he had not. He knew the payer evidence was thin and the adjacent use case was unproven. He had been thinking about it for months. What he did not have was a way to afford the answer with one clinical team, an enrolling trial, and a finite budget.
Those are not the same problem at two sizes. They are two different problems, and the second one is the one nobody writes about.
Regulatory evidence is not market evidence
Regulatory evidence is what FDA needs before you can make the claim. Market evidence is what a buyer needs before they sign. They overlap, they are not the same, and running one well makes it easy to believe you are covered on both.
The younger company had a market thesis and no regulatory definition. They were building toward equivalence with an established standard without having asked FDA which predicate they would be measured against. The validation work was real. It had not been checked against the body that decides whether it counts.
The later-stage company had the harder version, because the market side is not one audience. It is at least three, and they do not accept each other’s proof: the clinicians who decide whether to use the device, the institutions that decide whether it pays for itself, and the payers who decide whether to cover it at all. Each wants a different study. A demand signal from clinicians does not move a coverage conversation, and a company that treats the two as interchangeable will spend a year proving the wrong thing to the wrong room.
The trap is not blindness. It is the cost of looking.
It is tempting to say a company with a deep publication record stops asking whether its evidence is aimed correctly, that output gets read as proof of aim. Sometimes that is true. It was not true here, and assuming it is the failure mode sends you to the wrong fix.
This CEO knew. Knowing did not help, because the honest next question is not “is my evidence mis-aimed.” It is “which of several defensible studies do I fund, when funding one means not funding the others, and one of my most expensive assets is already committed to a trial for the market I have rather than the market I want.”
That is a prioritization problem wearing the mask of a strategy problem. It goes unsolved not because people cannot see it, but because seeing it produces a list of good options and no spare capacity, which is a worse feeling than not having looked. So the plan built early, against a real market, keeps running, because it is the one thing already resourced. The decision ages without anyone deciding.
The tell is not silence. It is a leadership team that can describe the adjacent opportunity fluently and has no study pointed at it. If they could not describe it, you would have a knowledge gap. When they can describe it in detail and still have nothing running against it, you have a prioritization gap, and it does not resolve on its own, because next quarter carries the same constraint as this one.
Why this is hard to fix from inside
Two reasons the team that built the plan is usually the wrong team to re-aim it alone.
The first is sunk commitment. Your most expensive study is already enrolling, the roadmap is already sequenced, and every option on the table competes with work you have defended to your board. Reviewing the plan feels like second-guessing effort that succeeded, so the review keeps not happening.
The second is that the answer is rarely a new study. More often it is already sitting in data you gathered for the market you have, or it collapses to a single comparison that stands between your current claim and the one you want to make. Finding that one comparison is most of the work, and it is genuinely hard to see from inside a company that has spent years looking at the same evidence through the same lens.
None of that is a character flaw. It is what focus costs. The same discipline that got a company to fifty publications is the discipline that keeps it pointed where it started.
When staying put is the right call
Re-aiming is not always correct. Moving into a new setting can mean a new indication, which is slow, expensive, and in direct competition with the trial you are already running. Sometimes finishing the market you have is the right answer, particularly if your beachhead is not saturated and the expansion waits on a coverage decision you do not control.
The failure is never choosing the near market. It is arriving there by default.
The younger company could not yet name its questions. The later-stage company named them on the way in the door and could not afford to answer them all at once. Neither was protected by where they were on the journey. What stage changed was the shape of the problem: from not knowing what to ask, to knowing exactly, and having to choose.
If you are the later-stage company in that description, you can probably describe the market you are not yet serving and point to nothing running against it, and the reason is capacity rather than blindness. That specific problem, sorting several legitimate evidence bets down to the one worth funding next, is the work I do with founders and operating teams. If it is the decision on your desk this quarter, it is worth a conversation before you commit the next study.
Arvita Tripati is the Founder and CEO of Vahana Labs, a B2B strategy consulting firm helping healthtech and medtech startups transition from pilot to enterprise contract. She has launched 30+ regulated AI-enabled products and worked with firms like the VA, Moderna, Gilead, NHS, and Bristol-Myers Squibb.