The United States represents more than 45% of the global medtech market, worth an estimated US$190 billion annually, and remains one of the most influential healthcare markets shaping global trends in investment, regulation and commercialisation.
But size alone does not explain why so many medtech companies look toward the US.
The country combines purchasing power, clinical influence, federal research funding and one of the world’s strongest venture ecosystems. At the same time, the US remains one of the most competitive and structurally complex healthcare markets globally.
The US concentrates capital, research and commercialisation at unusual scale
The United States is not only a commercial market. It is also one of the world’s largest ecosystems for translating research into healthcare innovation and commercialisation.
Federal organisations such as:
- NIH (National Institutes of Health)
- ARPA-H (Advanced Research Projects Agency for Health)
- BARDA (Biomedical Advanced Research and Development Authority)
invest heavily in biomedical research, breakthrough technologies and healthcare preparedness.
What often distinguishes the US is less the model itself and more the scale: larger pools of capital, concentration of influential institutions and stronger access to private investment throughout commercialisation. Combined, these conditions can create relatively short distances between research, financing and commercialisation.
This partly helps explain why many trends in medtech, digital health and healthcare investment emerge or accelerate in the US.
FDA determines market access — but regulatory pathways shape more than approval
The Food and Drug Administration (FDA) regulates medical devices, medicines and certain healthcare technologies in the United States and remains a critical gatekeeper.
The FDA operates several routes depending on how novel and high-risk a technology is considered:
510(k) - Technologies substantially equivalent to existing products
De Novo - Novel lower-risk technologies without an existing category
PMA - Higher-risk technologies requiring more extensive evidence
Programmes such as FDA Pre-Submission meetings or Breakthrough Device Designation may also enable earlier interaction with the FDA for technologies addressing serious conditions.
For European companies, FDA processes differ from CE marking. CE enables access to the European market through conformity assessment, while FDA clearance or approval provides access to the US market through pathways overseen by a central authority. Neither route is universally stronger, but they require different evidence strategies and timelines.
Regulatory pathways may influence more than approval alone. They can shape evidence generation, competitive dynamics and how technologies are perceived within healthcare systems.
The US healthcare system is shaped as much by payers as by providers
Unlike many healthcare systems where regional variation drives complexity, fragmentation in the US is often tied to who pays, who influences decisions and what outcomes different stakeholders value.
One important institution in this landscape is the Centers for Medicare & Medicaid Services (CMS), overseeing Medicare and Medicaid programmes and influencing how and under what conditions technologies may be reimbursed within parts of the healthcare system.
While the FDA determines whether technologies can enter the market, CMS influences reimbursement within federal insurance programmes. The two institutions serve different purposes and may follow different evaluation criteria, incentives and decision-making processes.
This means medtech companies may encounter multiple layers simultaneously:
- hospitals and health systems
- clinicians and department leaders
- Integrated Delivery Networks (IDNs)
- private insurers
- Medicare and Medicaid
- hospital Value Analysis Committees (VACs)
Two hospitals in the same city may operate under different reimbursement dynamics, procurement processes and economic incentives.
The payer landscape is broadly divided between:
Commercial payers – private insurers often influencing early adoption and uptake.
Medicare – the federal insurance programme primarily covering people aged 65+, reaching around 66 million Americans and often becoming important for long-term scale.
Medicaid – state and federally funded programmes supporting lower-income populations.
In practice, this means there is rarely one US market. Multiple adoption logics may operate in parallel, where commercial payers and leading hospital systems influence early uptake while Medicare becomes increasingly important for long-term scalability.
As a result, technologies may require different value propositions for clinicians, hospital finance teams and payers. This partly explains why local clinical, regulatory or commercial partnerships often become important in the US ecosystem, where decision-making is distributed across multiple stakeholders.
For some technologies, commercial success may also depend on coding pathways; standardised reimbursement codes used to classify procedures and determine how providers are paid.
For novel technologies without clear reimbursement codes, this may create additional complexity around adoption and scaling. This partly explains why reimbursement considerations often emerge earlier in development strategies.
Faster reimbursement pathways signal attempts to reduce friction in adoption
Recent US initiatives suggest increasing focus on reducing the time between regulatory approval, reimbursement decisions and implementation.
One example is RAPID, introduced to shorten timelines between FDA approval and reimbursement decisions within Medicare programmes overseen by CMS. Historically, reimbursement clarity could take more than a year after approval. Parts of that process are now intended to move within 60–90 days.
Another structural shift is the move toward value-based care, where healthcare providers are increasingly evaluated not only on treatment volume but also on outcomes, efficiency and cost reduction. This changes how technologies create value. Solutions improving throughput, reducing complications or lowering healthcare costs may become attractive for reasons extending beyond clinical performance alone.
The underlying challenge is not unique to the US. Healthcare systems globally are increasingly exploring how to accelerate adoption without compromising safety, accountability or economic sustainability. In Europe, discussions around revisions of the Public Procurement Directive (PPD) reflect similar concerns around implementation, although through different mechanisms.
Why the Boston–New York–San Francisco corridor shapes medtech far beyond its borders
Although the US healthcare ecosystem is geographically dispersed, influence often concentrates around a corridor stretching from Boston to New York and the San Francisco Bay Area.
These regions combine:
- leading academic institutions
- influential hospital systems
- venture capital
- biotech and medtech ecosystems
- regulatory and policy expertise
Validation within these environments may sometimes carry disproportionate influence beyond local markets.
Beyond this corridor, specialised ecosystems contribute in different ways:
Minneapolis → traditional medtech and device manufacturing
Houston → large clinical environments
San Diego → life science and biotech convergence
Entering the US is not always the question – timing often is
The size and influence of the US can create an assumption that it should always be the first expansion market. In practice, the picture is more nuanced.
For some companies, Europe may provide earlier clinical validation or faster access to real-world evidence. Other markets may offer lower commercial costs or stronger alignment with specific patient populations.
The strategic question is often not whether a company should enter the US. More often, it becomes:
When?
For what purpose?
And under which conditions?
The US rewards technologies that fit not only clinical needs, but also reimbursement structures, institutional incentives and economic realities. Understanding those systems may become almost as important as understanding the technology itself.
The opportunity in the US is not only market access — but understanding one of the world’s most influential healthcare systems
The United States is not simply the world’s largest medtech market. It is a healthcare ecosystem shaped by clinical incentives, reimbursement structures, investor expectations and regulatory pathways.
Companies operating in the US are not only interacting with a regulator or a healthcare provider. They are navigating a system where financing, evidence, adoption and commercialisation are closely interconnected.
For medtech companies, understanding the US is therefore less about accessing one market and more about navigating one of the world’s most influential healthcare systems.
This article is part of our internationalisation series exploring how healthcare systems, reimbursement structures and market dynamics shape medtech commercialisation across different global markets. You can also explore our foundational article on international medtech expansion.
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