The Myth of the Perfect Study for U.S. Market Access

If you work in medtech, you’ve probably heard some version of this advice: “Just do the right study, make sure you capture endpoints of interest to U.S. payers, publish it in a good journal, and you will have coverage.”

It’s a comforting idea. One definitive piece of evidence, universally recognized, that unlocks coverage everywhere, except for a few payer hold-outs in isolated pockets.

But in reality, there’s almost never a single “perfect” study that opens every door. Coverage decisions are made by multiple payers, in different contexts, for different reasons—and each has its own lens on what “good evidence” looks like.

Why One Study Rarely Does It All

The U.S. reimbursement landscape is fragmented by design. Medicare has national and local coverage determinations. Medicaid programs are state-run. Commercial insurers each have their own medical policy criteria. Even when these payers look at the same study, they may interpret it differently based on their own member population, cost profile, and internal thresholds for clinical benefit.

A randomized controlled trial might be the gold standard for demonstrating efficacy, but if the comparator arm doesn’t match a payer’s “standard of care,” they may not find it persuasive. A large registry study might show strong real-world outcomes, but if it lacks certain endpoints, it may be considered incomplete. And a study designed for FDA clearance might not address the economic questions a payer cares about at all.

Building a Body of Evidence

Instead of chasing the idea of a single perfect study, most successful market access strategies are built on a portfolio of evidence. This might include:

• A pivotal trial to establish safety and effectiveness for regulatory purposes

• Real-world data from early adopters to demonstrate impact in routine practice

• Economic analyses to quantify cost offsets or budget impact

• Subgroup analyses to show value in high-risk or high-cost populations

• Longitudinal follow-up to address durability of outcomes

Each piece contributes to the overall story, and different payers may value different parts of that story more highly.

The Role of Timing and Sequencing

U.S. payers don’t all move at the same pace. Medicare may update a coverage determination years before a major commercial plan changes its policy. Medicaid decisions may hinge on State legislative sessions or budget cycles.

That’s why sequencing matters. An early trial can open the door for initial coverage in certain segments, while real-world evidence and economic modeling build momentum for broader adoption. Over time, the cumulative effect of multiple studies, in different formats, for different audiences, is what shifts coverage from scattered to widespread.

Redefining “Enough”

The takeaway for medtech innovators is that “enough evidence” isn’t a single event—it’s a moving target shaped by payer type, patient population, and competitive landscape. Instead of aiming for the elusive perfect study, aim for the right mix of studies that together answer the regulatory, clinical, and economic questions that matter to your customers and their payers.

In market access, progress is usually incremental. But when each step is intentional and aligned to payer needs, the cumulative effect can be just as powerful as the mythical “perfect” study—without the wait for a unicorn that doesn’t really exist.

Build Your Market Access Strategy With the Right Evidence — Not Just the “Perfect” Study

Trying to align your clinical and economic data with U.S. payers?

At Coustier Advisory, we help early-stage MedTech teams develop reimbursement strategies that go beyond FDA trials — and speak directly to payer decision-makers.

Schedule a 30-minute consult to explore how your current study plan stacks up — and what evidence you may need to unlock broader coverage.

Learn more about Coustier Advisory.