Jaishankar Kutty, Ph.D., VP of Regulatory, Reimbursement, and Access, Cardiovascular Center of Excellence, RQM+
I have spent most of my career at the intersection of clinical evidence, regulatory science, and reimbursement reality. I have watched devices with genuinely compelling science move through pivotal trials, achieve approval, and then stall because the commercial infrastructure to support adoption was never built into the program design.
At LSI USA 2026, I presented a framework I have been developing over years of working through CMS coverage decisions, IDE studies, national coverage determinations, and payer advisory boards.¹ The core argument is simple: Most reimbursement outcomes are decided before approval, not after.
The evidence design choices you make at the protocol stage determine whether your device ends up just being approved, or being approved, covered, and adopted.
The Most Dangerous Word in MedTech
“Eventually.” Reimbursement … eventually. CPT code … eventually. Coverage … eventually. Adoption … eventually.
I have seen this word appear in business plans, investor decks, and board presentations more times than I can count. What it tells me is that the team has achieved regulatory clarity and commercial ambiguity at the same time. The approval is real, but the revenue is theoretical. And the path between them is treated as something to figure out later. The problem with that approach is that “later” is exactly when you have the least leverage to fix it.
The three forces that determine whether a device actually reaches patients are regulatory, clinical, and economic.
- Regulators determine whether a device can exist
- Clinicians determine who will benefit
- Payers determine whether it will be used
These are simultaneous constraints on the same study design, not sequential steps. A trial built to satisfy only one of them is a trial that leaves the other two to chance.
Evidence That Wins Twice
The devices that achieve genuine commercial success share a pattern. The evidence was designed to satisfy regulatory reviewers and payer decision-makers with the same data. The patient population looked like the real-world population the system will actually reimburse, not a carefully curated, anatomically pristine cohort optimized for clean Kaplan-Meier curves. The primary endpoints demonstrated patient-centered benefit and system value, with technical metrics in a supporting role. And real-world evidence was built into the program architecture from the start, not retrofitted after approval when the coverage question came to the forefront.²
The devices that stall share a different pattern. Evidence is only sufficient for clearance. The value story is vague or absent. No credible plan exists for permanent coverage. These outcomes are rarely surprising in hindsight. The signals were there in the protocol design because evidence design determines commercial destiny.
The Hospital Economics Test
There is a layer of this problem that does not receive enough attention, and that layer is hospital economics. Even when a device achieves coverage, adoption can stall because the economics punish the institutions being asked to use it.
Two structural forces can quietly kill adoption at the hospital level:
- Payment misalignment means that if a hospital loses money on every case, innovation gets rationed regardless of clinical benefit.
- Workflow burden means that unpaid clinician time accumulates as resistance, even when no one says so directly.
Before a hospital adopts a new technology, the real questions being asked are whether it improves outcomes, reduces cost or risk, and fits the payment model. Hospitals do not reject innovation. They reject negative margin.
A reimbursement strategy that stops at coverage without modeling the hospital economics of adoption is only half a strategy.
Post-Market Evidence Is the Second Approval
The program does not end at approval. Post-market evidence is how the system updates its belief about your device, and that updating process shapes coverage renewal, indication expansion, and pricing defense over the long term.³ Post-market evidence either compounds the value of your approval or steadily erodes it. Teams that treat post-market surveillance as a compliance obligation rather than a strategic asset are leaving the most durable part of their commercial story unwritten.
The practical implication is that PMCF strategy, registry architecture, and claims linkage planning should not be deferred until after approval. They need to be designed alongside the pivotal evidence plan, because the payer questions that arise post-approval are predictable, and the ability to answer them depends on data that have to be collected prospectively.²
A Self-Check Before You Lock the Protocol
Before your pivotal trial begins, four questions are worth sitting with:
- Are the patients in your study the patients the system will actually reimburse?
- Are you comparing against what payers already fund?
- Will your endpoints demonstrate system value, not just biological effect?
- Will your evidence survive payer scrutiny three years after approval?
If any of those questions produce hesitation, there’s still time to respond. Once the trial is locked, the runway is committed, and the market has formed an impression of your device, the room to maneuver shrinks considerably.
Reimbursement problems designed into the protocol have an obvious solution. Design the protocol differently — before the evidence is locked, not after.4
Frequently Asked Questions
Why isn’t regulatory approval enough to drive adoption and reimbursement?
Regulatory approval establishes that a device is safe and effective for its intended use. Coverage decisions require evidence that the device improves outcomes and delivers value in the real-world population a payer is responsible for, which is often broader, older, and more complex than the population studied in a pivotal trial. These are different evidentiary standards, and a program designed to satisfy only one of them will routinely fail the other.
What does a reimbursement-ready trial design actually look like?
It starts with a patient population that reflects real-world complexity rather than optimized study conditions. It includes primary endpoints that capture patient-centered outcomes and system impact alongside technical performance metrics. It has a comparator arm built around what payers already fund. And it incorporates a post-market evidence architecture (registry participation, claims linkage, PMCF strategy) designed from the start rather than retrofitted after approval.
When is the right time to bring reimbursement strategy into the development process?
Early feasibility is not too early. The protocol decisions made before a single patient is enrolled determine whether the evidence can answer the coverage questions that will arise years later. By the time a pivotal trial is locked, and the device is approaching approval, the most consequential reimbursement strategy decisions have already been made — often without anyone in the room asking the payer questions.
References
1 Kutty, J. (2026). Approved. Covered. Adopted. Presented at LSI USA 2026, Waldorf Astoria Monarch Beach Resort, Dana Point, California. March 17, 2026.
2 Centers for Medicare & Medicaid Services. Coverage with Evidence Development. Accessed 2025. https://www.cms.gov/medicare/coverage/evidence
3 Centers for Medicare & Medicaid Services. Medicare Coverage of Investigational Device Exemption (IDE) Studies. Accessed 2025. https://www.cms.gov/medicare/coverage/investigational-device-exemption-ide-studies
4 Centers for Medicare & Medicaid Services. Final Notice — Transitional Coverage for Emerging Technologies (CMS-3421-FN). 2024. https://www.cms.gov/newsroom/fact-sheets/final-notice-transitional-coverage-emerging-technologies-cms-3421-fn
