US market roadmap for medical devices – a European perspective

Translation: Original published in Finnish on 3/27/2026 at 8:56 am EET.

The US is clearly the largest single market for medical device companies. What makes the market attractive is its large size, uniform regulation, and high prices, which is why innovative companies usually aim to commercialize their products in the US first. On the other hand, the operating environment is complex, navigating it takes time and money, and it can be difficult for investors to grasp. Commercial success after regulatory approvals requires, for example, securing reimbursement, building clinical credibility, gaining access to hospital procurement systems, and establishing a local organization. In this article, we will go through what we believe are the most important success factors and milestones for a medical device company commercializing its innovation in the United States.

The FDA route impacts the burden of proof and reimbursement

One of the most important early-stage decisions is the choice of the FDA (Food and Drug Administration) approval pathway: whether to pursue 510(k), De Novo, or PMA approval (see our previous article on FDA pathways). The 510(k) route is based on substantial equivalence to an already approved predicate device. The De Novo and PMA paths, in turn, are for higher-risk devices without an approved predicate device. Each path differs significantly in terms of timeline, evidence requirements, and costs. In addition, the choice has direct implications for reimbursement. The PMA and De Novo pathways are more burdensome in terms of regulation, but approved devices meet the requirements of reimbursement mechanisms much more easily than 510(k) devices. These include the NTAP (New Technology Add-on Payment) and pass-through mechanisms for new innovative solutions. In addition, FDA Breakthrough Device status opens access to the TCET (Transitional Coverage of Emerging Technologies) pathway, which can accelerate Medicare coverage. In other words, PMA and De Novo devices may receive more favorable pricing from payers compared to 510(k) devices.

Clinical evidence – stakeholders may have different requirements

Building clinical evidence is a bridge between regulation and commercialization. Different stakeholders may have slightly different requirements, and the commercializing company must design studies to meet these needs. Pivotal marketing authorization studies should therefore be designed from at least three perspectives: 1) Obtaining FDA approval, 2) achieving the most favorable reimbursement possible, and 3) convincing opinion leaders and hospital Value Analysis Committees (VAC) of the product's value. Evidence sufficient for FDA approval may not be enough for the payer to justify reimbursement. Ultimately, the VAC has the final say in product adoption, and they may also have their own requirements, for example, regarding cost savings, shorter treatment periods, and reduced re-admission. In our view, the weight of high-quality clinical evidence, especially randomized and blinded studies (so-called Level 1 studies), is continuously increasing.

The KOL network attracts followers

Identifying and engaging key opinion leaders (KOLs) may begin years before launch and continue throughout commercialization. The goal is typically to identify a group of respected leading physicians in the field and engage them as researchers, advisors, or educators. In practice, KOLs can communicate about the product at congresses, in peer-reviewed publications, and in discussions with their colleagues. This helps build clinical credibility and disseminate information in often highly competitive and conservative markets. 

Reimbursement and go-to-market strategy

Success in reimbursement is crucial for commercial success. The reimbursement strategy must be developed well in advance of the expected FDA approval. In the early stages, it needs to be determined, for example, 1) whether a CPT code (an identifier defined by the AMA) exists for the procedure, or if a new one is needed 2) What is the product's placement in Medicare's (federal health insurance program for the elderly and disabled) payment environment: inpatient (DRG), outpatient (APC), or day surgery (ASC)? 3) Are the criteria for additional reimbursement mechanisms (NTAP, pass-through, or TCET mechanisms) met? 4) Commercial payers' perspective: Do major national insurers cover the product, or are additional measures needed? 

Building a local organization

A European company typically needs local management and a team in the United States. Managing and leading the various components of commercialization typically requires a strong local presence in addition to building relationships and managing sales operations. Quality, regulatory, reimbursement, and medical capabilities must either be built or acquired from contract partners in the US. In our view, an undersized organization in the United States is quite often a contributing factor to the commercialization challenges faced by European companies in the US. For early-stage companies, this often represents a significant financial commitment, so balancing the scale of the investment is often a very important decision for these companies.

Sales organization and distribution strategy

Regarding sales strategy, the options roughly boil down to direct sales, distributors, or a hybrid model combining both. A direct sales organization is expensive, but on the other hand, it offers full control over sales and training. Distributors bring established relationships with hospitals and doctors to the table, but on the other hand, they weaken the gross margin and do not allow for direct customer contact. Typically, European med-tech companies start with a small in-house sales team in a limited geographical area and grow the organization once a functional sales model is found. For implantable or technically demanding devices, the sales representative is often present during the procedure – which makes the representative's expertise and training very important and supports the use of direct sales. On the other hand, for less demanding devices, the distributor model can be more functional and capital-light. Companies often end up with a hybrid model in practice, aiming to optimize the best aspects of different approaches within resource constraints.

User training

The adoption of a new product often requires training for the entire care team: in addition to the physician, for example, operating room nurses and technicians. Investing in training programs is very common among companies and indicates the importance of training. Training can take place, for example, in cadaver labs, with various simulation models, in supervised initial procedures, and through certifications. If successful, training programs can accelerate adoption and reduce adverse events. A well-functioning KOL network can bring added value: peer training led by a respected colleague can be more effective than training conducted by the company itself.

Agreements with procurement organizations

Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs) control purchasing decisions in a significant portion of US hospitals. Their task is to enter into framework agreements and centralize purchases. Signing agreements with these organizations opens sales access to a larger number of hospitals, but the agreement itself does not yet guarantee sales. The key GPOs include Vizient, Premier, and HealthTrust. As for IDNs, these include HCA, CommonSpirit, and Kaiser.

For new technology, commercialization typically begins in a few carefully selected hospitals. As usage increases and treatment outcome data accumulates, access to GPO/IDN systems will gradually become more relevant. GPO/IDN Value Analysis Committees (VACs) can be particularly important, as a single committee decision can open or close dozens of hospitals simultaneously.

Post-market evidence

In our view, clinical trials and real-world evidence are increasingly important factors in the long-term expansion of device use. CMS (Centers for Medicare & Medicaid Services), commercial payers, and hospital systems all require real-world data: registries, post-market studies, and comparative effectiveness data to justify product use. Early adopters can try out new innovative solutions with a low threshold, but convincing large user masses requires, in our estimation, a high level of evidence regarding safety, efficacy, and effectiveness. In practice, this often means large, randomized, and blinded studies. Comparative studies are the best, but companies may not be willing to conduct them if there is a risk of their own product losing to a competitor in a direct comparison. Strong data also helps defend reimbursement: NTAP, TCET, and pass-through are temporary mechanisms, and maintaining favorable reimbursement levels after their expiration requires strong evidence of the solution's value. 

Summary

From an investor's perspective, successful commercialization in the US is often critically important. However, understanding the multifaceted and sometimes complex operating environment can be challenging. For the reasons mentioned in the article, revenue growth is typically slow and gradual, which is why market growth expectations are often overly optimistic. On the other hand, careful preparation and execution of these steps help the company build a permanent foothold, which can provide defensive revenue and high profitability in the long term. If the product is sound and the groundwork is done well, once the flywheel gets going, it can lead to excellent long-term results.