How U.S. Reimbursement Impacts MedTech Product Design
When we talk about bringing a new medical technology to market, it’s easy to picture the pathway as a straight line: concept → R&D → regulatory clearance → commercialization. But in the U.S., there’s a parallel track running alongside that product roadmap, one that’s just as critical to success: reimbursement.
While reimbursement is often thought of as something that happens after FDA clearance, the truth is that payment mechanics can and should influence decisions made much earlier, even in the design phase. Ignoring these considerations until the end can lead to costly redesigns, delayed adoption, and lost market opportunities.
Why Reimbursement Mechanics Matter Early
The U.S. reimbursement system isn’t a single set of rules. It’s a patchwork of coding, coverage, and payment policies, each with their own timelines, evidence requirements, and quirks.
For example:
Coding determines whether providers even have a way to submit a claim for your technology.
Coverage policies decide when and for whom that claim will be paid.
Payment systems dictate how much is paid and whether it covers the cost of adopting your product.
Each of these elements interacts with your product’s clinical profile, indications for use, and even physical attributes. Decisions made during development, like whether a procedure is performed in an outpatient surgery center or a physician’s office, can influence which payment system applies and whether adequate reimbursement is available at launch.
Examples of Early Impact
Site of Service: Choosing a target care setting without understanding the payment environment can be a trap. The same procedure may be financially viable in one setting and underwater in another, even with the same code.
Procedure Workflow: Adding or removing steps in a procedure can change which codes apply, whether those codes are bundled, and whether separate payment is possible.
Device Classification: The difference between being categorized as a durable medical equipment (DME) item versus a surgical supply can mean different payment rates, benefit categories, and coverage criteria.
Adjunct vs. Standalone Use: A product designed to work alongside an existing procedure may run into bundling rules, whereas a standalone procedure might qualify for its own payment pathway—but require a more extensive coding process.
The Ripple Effect of Payment Systems
Medicare payment systems like the Physician Fee Schedule (MPFS), Outpatient Prospective Payment System (OPPS), and Ambulatory Surgical Center (ASC) Payment System each have their own logic for setting payment rates. Commercial payers may follow Medicare’s lead or adopt entirely different structures.
If a product is developed without considering these differences, it can end up fitting neatly into a regulatory category but awkwardly—or unfavorably—into a payment system.
Integrating Reimbursement Thinking into Product Development
Bringing reimbursement into the conversation early doesn’t mean letting payment rules stifle innovation; it means making informed choices that help your technology succeed in the real world. One of the most effective ways to do this is to engage reimbursement expertise before you’ve locked in the product’s design, target care setting, or clinical trial parameters. By understanding the coding, coverage, and payment landscape for each intended use case, you can see where opportunities and obstacles might lie.
It also means shaping your evidence plan to answer not just the regulatory question of “Is it safe and effective?” but the payer’s question of “Is it medically necessary and worth covering because it’s better or cheaper?” Aligning study endpoints, patient selection, and follow-up periods with the needs of payers ensures that when the time comes, your data will resonate with decision-makers.
Finally, it’s important to stress-test your business model against realistic payment assumptions for each relevant care setting. This helps identify whether the economics will work for providers and whether additional coding or payment advocacy will be needed before launch. When reimbursement considerations are integrated from the start, the path to market becomes clearer, faster, and far more sustainable.
A Better Path to Market
Incorporating reimbursement mechanics into product development isn’t about letting finance dictate innovation—it’s about ensuring that innovation can actually reach patients. A product designed with reimbursement realities in mind can accelerate adoption, support provider economics, and strengthen long-term market sustainability.
In the U.S., that’s not just a competitive advantage—it’s a critical part of bringing good ideas to life.
Have questions about how U.S. reimbursement could impact your product design?
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