Regulatory clearance is not the hard part. Getting clinicians, labs, and payers to change behavior; that’s where most diagnostic launches fail.

If you work in commercial, HEOR, or market access at a diagnostic company, you have likely lived this.

A test that is faster, more sensitive, or more clinically informative than the current standard clears the FDA and the market barely responds. Adoption is slower than projected, health system pilots stall., reimbursement lags, and the commercial team is left trying to explain a gap between clinical promise and real-world uptake.

Most of the time, that gap can be traced to three predictable, avoidable mistakes.

‍

Mistake #1: Selling to the Lab When the Decision Lives Elsewhere

Labs run the tests, but they rarely decide to change clinical protocols. The decision to adopt a novel diagnostic is distributed across a web of stakeholders (physicians, nurses, infection control, hospital administration, and payers) each with different incentives and definitions of value.

Even when a lab adds a test to its menu, value may never be realized if ordering physicians don’t change their treatment decisions in response. A rapid result that sits unreviewed until morning rounds is not a rapid result at all. Realizing the clinical value of a diagnostic innovation requires coordinated behavioral change across the entire care delivery system, and that requires a commercial strategy built around multi-stakeholder engagement, not a single point of sale.

‍

Mistake #2: Stopping at Clinical Validity

The evidence required for FDA clearance and the evidence required for real-world adoption are not the same. Regulators want clinical validity; they ask, does the test accurately identify the condition? Payers, guideline bodies, and health system formulary committees want clinical utility; they ask, does using this test actually change decisions and improve outcomes?

To shift payer policy, update clinical guidelines, and win formulary placement at major health systems, your HEOR and market access teams need to demonstrate:

• Real-world comparative outcomes against current standard-of-care tests
• Measurable downstream impact: reduced length of stay, fewer unnecessary treatments, lower total cost of care
• Evidence tied to specific clinical settings, not just aggregate trial populations

Generating this evidence is expensive and time-consuming. That is precisely why it must be planned well before launch and not assembled under pressure after access conversations have already started.

‍

Mistake #3: Ignoring the Economics of the Care Setting

This is the mistake most often missing from commercial planning and it surfaces fast once you are in front of a health system.

Inpatient lab tests are often bundled into the DRG payment, meaning a new, costlier test generates additional cost for the lab without generating additional revenue. That is a structural barrier regardless of clinical merit. Point-of-care, outpatient, and reference lab settings each carry different reimbursement dynamics and decision-makers.

A credible access strategy accounts for each setting your test will enter. That means being clear on:

• Which CPT codes apply, and what the current coverage landscape looks like across payer segments
• Who bears the cost in each setting and who captures the clinical and economic benefit
• What evidence investments are required to move payer policy by setting, not just in aggregate

‍

What the Companies Getting This Right Are Doing Differently

The diagnostic companies achieving real-world adoption share a common approach. They treat regulatory clearance as the start of a new phase of commercial investment. In practice, that looks like:

• Engaging adoption stakeholders during development, not after approval. Physician pull, lab buy-in, and payer receptivity do not emerge on their own. They are built through early, structured stakeholder engagement.
• Building real-world evidence collection into clinical programs. The HEOR and RWE roadmap should be drafted alongside the regulatory strategy, not handed off after clearance.
• Setting commercial timelines that reflect reality. Protocol change at major health systems takes years, not months. Commercial forecasts that ignore this will consistently disappoint.

‍

The Bottom Line

The healthcare system does not change its behavior because a test is technically superior. It changes because the right stakeholders are convinced, the evidence is real-world and comparative, and the economics work for the settings involved.

For commercial, HEOR, and market access leaders, that is the real strategic challenge. Not proving your test is better, but building the plan that actually gets it used.

That plan has to be holistic.

Clinical guideline strategy comes first: identifying the KOLs and clinical society relationships that shape protocols and give payers permission to act.

Alongside that, a phased evidence generation roadmap, one that goes beyond satisfying today's requirements and anticipates what payers and formulary committees will require two and three years from now.

Then a setting-by-setting reimbursement strategy: CPT code pathways, coverage gap analyses, and the budget impact models that health system formulary committees and payer medical directors use to say yes or no.

And none of it stops at approval.

The market development work - physician education, lab onboarding, outcomes tracking, and the feedback loops that identify where adoption is stalled - is what closes the gap between a test being available and a test being genuinely embedded in care.

---

Betsy J. Lahue is CEO of Alkemi, a life sciences consulting firm specializing in HEOR, Market Access, and Market Shaping.

Alkemi has contributed to launches representing tens of billions in global sales and partners with diagnostic and life sciences executives to build value and access strategies that translate clinical innovation into real-world adoption. To discuss your program, contact us at www.alkemihealth.com/contact