Your Protocol Is a Market Access Document. Write It That Way.

I find myself saying some version of this almost every week:

“This is not a pivotal study. This is not a regulatory study. So why are we designing it like one?”

I’m pretty sure that even then, despite my directness, they’re not quite sure what I mean.

For better or worse (mostly the latter in my opinion) we have an entire culture of research that was raised on the idea that the traditional RCT is the gold standard for nearly everything. It’s also what clinical researchers know best. It’s the cornerstone of pharmaceutical research which, unlike medtech, has been the model for the majority of contract research.

I am not passing judgment or casting dispersions. The protocol is often thoughtful, detailed, and built by smart people with good intentions. The problem is that most teams are reviewing the protocol as a research document whereas I am reviewing it as a future market access document.

Because like it or not – your protocol is about to become a template.

One of the biggest surprises for medtech executives is realizing that protocol decisions made today can influence reimbursement conversations years later. Inclusion criteria, documentation requirements, comparators, endpoints, site selection, and follow-up schedules do not just affect study execution. They shape the evidence package that payers, providers, health systems, investors, and clinical societies will eventually evaluate.

A protocol is not just a plan for collecting data. It is often the first draft of the commercialization story.

Why This Matters More Than Most Companies Realize

When companies think about commercialization, they often focus on reimbursement strategy, coding strategy, market access planning, publications, and health economic evidence as separate workstreams.

In reality, many of those future conversations are constrained by decisions already embedded in the protocol.

I’ve seen companies spend years and millions of dollars generating evidence only to discover that the study was designed around scientific curiosity rather than a true understanding of how market-facing decisions (especially reimbursement!) are made.

The frustrating part is that most of these problems were visible before the first patient was enrolled.

Three Protocol Red Flags I See Repeatedly

1. The Study Population Is Narrower Than the Intended Market

This happens constantly.

A protocol may limit enrollment to a very specific patient population because it feels cleaner scientifically. It’s what they think they’re supposed to do. The resulting study population becomes highly selected, highly controlled, and easier to analyze.

I recently used an ovarian cancer diagnostic example when discussing this issue. Imagine a study that only enrolls post-menopausal women, between ages 45 and 75, with elevated CA-125 levels, who have already been referred to specialty centers and are already scheduled for surgery.

This kind of protocol can accidentally create evidence that only supports use in a highly selected surgical-referral population, not the broader real-world population where the diagnostic may actually be used.

The payer may later say:

“You studied post-menopausal, high-risk, surgical patients in tertiary centers. Why should we cover this for community OB/GYN evaluation, indeterminate adnexal masses, pre-surgical triage, or broader diagnostic workup?”

That is exactly the protocol-as-market-access-document issue. The criteria may make the study easier to analyze, but they can quietly limit the future coverage story.

2. The Protocol Teaches Restrictive Coverage

This is the mistake almost nobody talks about.

Many teams assume that more documentation equals better evidence.

So they require highly specific baseline evaluations, multiple specialist consultations, extensive documentation requirements, and frequent reassessments throughout the study.

The protocol looks rigorous.

The problem is that future coverage policies often follow the evidence.

If your study requires five pieces of documentation before a patient qualifies, do not be surprised when a payer later asks for five pieces of documentation before approving coverage.

If your study requires burdensome reassessments every few months, do not be surprised when future utilization management requirements begin to resemble those reassessments.

3. The Endpoints Are Scientifically Interesting but Commercially Incomplete

Scientific rigor matters.

Clinical relevance matters.

But those are not always the same as commercial relevance.

A protocol may include highly sophisticated clinical endpoints while overlooking outcomes that influence reimbursement, provider adoption, value analysis committee review, or health system decision-making.

Sometimes the missing piece is healthcare utilization. Sometimes it is treatment burden. Sometimes it is workflow impact. Sometimes it is patient adherence.

The point is not that every study needs every endpoint.

The point is that endpoint selection should reflect the decision the evidence is intended to influence.

What a Strategic Protocol Review Looks Like from a Strategic CRO

A strategic protocol review asks different questions.

Not just:

Is the study scientifically sound?

Is the statistical plan appropriate?

Is the study adequately powered?

But also:

What commercialization milestone is this study supporting?

What payer question will this evidence answer?

What future claim are we trying to support?

Does the comparator align with market realities?

Are we unintentionally narrowing future coverage?

Does the evidence package support adoption, reimbursement, and scale?

Those questions often reveal risks that are invisible during a traditional protocol review.

TTi’s Perspective

One of the most common misconceptions in medtech is that commercialization begins after the study is complete.

In reality, commercialization often begins when the protocol is written.

That is why protocol review is one of the highest-leverage activities a company can undertake before launching a pragmatic study, clinical utility study, observational study, or post-market evidence generation program.

At TTi, we spend a great deal of time helping companies bridge the gap between scientific validity and commercial readiness.

Before you activate sites, finalize budgets, and enroll your first patient, it is worth asking whether the protocol has been reviewed through a translational lens that connects Med Affairs, reimbursement, market access, adoption, and evidence generation strategy.

The answer may change the study.

And in some cases, it may change the future of the technology

Remember:

Evidence is only valuable if it changes the next decision.

– Dr. April