The gauntlet every medtech company faces in the US

Writer: Dr. Dylan Attard, CEO and Co-founder, MedTech World

Key points:

• • Regulatory complexity, reimbursement barriers, and capital constraints are the defining obstacles for MedTech companies entering or scaling in the U.S. market.
• • The FDA’s evolving approach to AI-enabled devices has added a new layer of uncertainty that companies must plan for from the earliest stages of product development.
• • Companies that treat market access as a post-approval problem, rather than a design-stage one, find themselves locked out of the revenue they worked years to reach.

June 2026 — The United States is the largest medical technology market in the world, accounting for roughly 40% of global medtech revenue. It is also one of the most demanding to navigate. For companies that get it right, the rewards are enormous. For those who underestimate its complexity, the consequences include years of delays, eroded capital, and missed commercial windows that do not come back around.

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I trained as a surgeon before moving into the commercial side of healthcare. I built and scaled a global event platform connecting the medtech industry across multiple continents. Today, I sit on the team at Edge Medical Ventures, where we back founders navigating exactly these pressures. That combination of clinical training, operational experience, and investment perspective shapes everything I am about to say. The challenges below are patterns I have watched play out repeatedly, across markets and business models.

The regulatory labyrinth

No challenge looms larger than the FDA. The U.S. regulatory pathway is among the most rigorous in the world, and for good reason. Patient safety demands it. But rigor and unpredictability are not the same thing, and the industry has struggled with both.

The 510(k) clearance pathway, which most Class II devices rely on, has become slower and more document-intensive than it was a decade ago. The De Novo pathway, designed to give novel low-to-moderate-risk devices a route to market without a predicate device, remains underutilized in part because timelines are difficult to predict. And PMA (Premarket Approval for the highest-risk Class III devices) is a multiyear undertaking that demands clinical evidence at a scale that strains even well-funded companies.

What has made this more complicated in recent years is the surge of AI and machine learning-enabled devices. Having spent considerable time in Asia over the past few years, particularly in Hong Kong, I have observed something that U.S.-centric commentators often miss: regulators in markets like Singapore, the UAE, and parts of Southeast Asia are moving faster than the FDA on adaptive frameworks for AI-driven medical tools. That is not a criticism of the FDA so much as a reality check. The FDA has cleared hundreds of AI-driven tools, primarily in radiology and diagnostics, but its regulatory framework for these products is still maturing. The concept of a “predetermined change control plan,” which allows companies to update algorithms post-approval within defined parameters, is a step forward, but it introduces new compliance obligations that many companies are not yet equipped to manage. For any medtech company building intelligence into its core product, regulatory strategy can no longer be delegated to a single affairs team working in isolation. It has to be embedded in product development from day one.

 Reimbursement: The second gate

FDA clearance is often described as the hardest part of bringing a medtech product to market. In my experience, it is the first hard part. Reimbursement is frequently harder, and it receives far less attention in the early stages of company building.

The Centers for Medicare & Medicaid Services (CMS) controls the reimbursement landscape for the majority of U.S. patients, and its coding and coverage processes operate on timelines that are entirely decoupled from FDA approval. A company can achieve FDA clearance and then spend three to five years working through the New Technology Add-on Payment process, navigating MAC coverage determinations, or waiting for a new CPT code assignment.

Private payers add another layer. Each major insurer maintains its own coverage policies, its own evidence thresholds, and its own prior authorization requirements. A device that is reimbursed by Medicare in one state may face coverage denials from a major commercial payer in another. The result is a patchwork reimbursement environment that requires companies to staff up for payer affairs work that, a decade ago, many assumed was the hospital’s problem to solve.

The practical implication for company leaders is stark: reimbursement strategy must begin before clinical trials are designed, not after. The evidence you generate needs to answer not just the FDA’s questions, but the questions CMS and private payers will ask.

 The capital challenge

Medtech is a capital-intensive business. Long regulatory timelines, expensive clinical studies, and complex manufacturing requirements mean that even modestly ambitious companies often need $50 million to $150 million or more before they reach commercial scale. The venture capital environment for medical devices has tightened significantly since the peak years of the last decade.

Investors who once backed early-stage device companies have increasingly shifted toward digital health, biopharmaceuticals, and software-driven models with faster paths to revenue. The companies that continue to attract capital are those that can demonstrate not just clinical efficacy, but a credible plan for reimbursement and a realistic picture of the commercial infrastructure required to drive adoption.

This has placed a premium on leadership teams that understand both the science and the business of medtech. A compelling clinical story is necessary but no longer sufficient. Boards and investors want to see that the team has mapped the reimbursement pathway, identified the hospital value analysis committee dynamics, and understood the purchasing realities of their target market.

 Talent and supply chain pressures

Two additional pressures deserve mention. The medtech sector is facing a persistent talent shortage, particularly in regulatory affairs, clinical operations, and field-based clinical support. Companies that have historically relied on a handful of experienced hires to carry these functions are now competing aggressively, and expensively, for a limited pool of qualified people.

Supply chain fragility, exposed sharply during the COVID-19 pandemic, has not fully resolved. Single-source dependencies, long lead times on critical components, and manufacturing concentration in a small number of geographies continue to create vulnerability for companies that have not diversified their supply chains or built adequate buffer inventory.

 The path forward

None of these challenges is insurmountable. The companies that succeed in the U.S. medtech market share a common trait: they treat complexity as a design constraint, not an external obstacle. They build a regulatory strategy into their earliest product decisions. They design clinical programs with payer evidence requirements in mind. They staff for commercial reality, not just launch day.

These are exactly the conversations I will be bringing to MedTech World North America 2027, taking place from May 5-7, 2027, at the Hilton in West Palm Beach, Florida. If you are a founder, investor, or operator working through any of the challenges above, I would encourage you to be in the room. The U.S. market rewards preparation. It does not wait for those who arrive without it.

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