US Emerging as Top Global Medtech Destination

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to entering the U.S. market. But more recently, especially with the EU’s implementation of the complex and burdensome Medical Device Regulation (MDR) requirements for obtaining a CE mark for medtech products, Europe has started losing its status as the preferred medtech product launchpad.

International companies have more recently been shifting operations to the US in preparation for launching their products in the region. About 89% of medtech executives said they will prioritize US regulatory approval, according to a Boston Consulting Group (BCG) and UCLA Biodesign survey.¹

As a result, the world’s largest medtech market, accounting for roughly 40% of the global medtech market, will now see medtech companies entering much earlier in their life cycle. This transition necessitates that companies navigate U.S.-specific regulatory, corporate, and intellectual property regimes at an earlier point in their life cycle than many of their past predecessors. We will explore each of these topics in a series of articles.

European Regulatory Challenges Drive Medtech Firms to US

The introduction of MDR in 2021 is likely a key catalyst in driving more medtech companies to seek device approvals in the U.S.

The MDR regulation increases the safety criteria required for medical device regulatory approval, in many cases including new clinical evidence. Devices with software components are subject to particularly rigorous requirements due to potential data privacy risks.

Companies are required to obtain a certificate confirming that they meet MDR safety requirements before marketing and selling their devices. As feared, the stringent rules have created bottlenecks and delays: more devices are now falling into higher classifications under the MDR, meaning increased data requirements and increased review from Notified Bodies, who are themselves adjusting to an increased volume of work on an increased number of devices under the MDR regime. This all impacts the timeline for certification.

According to a 2022 survey of MedTech Europe members, the time required for device certification roughly doubled after the MDR regulations took effect. More than 85% of previously certified devices had not received MDR certificates at the time of the survey.

According to a more recent 2024 MedTech Europe survey, uncertainty around certification timelines persists and costs significantly increased for clinical evaluation, post-market surveillance, and certification.

Established US Regulatory Processes May Lure Medtech Companies

Medtech companies pursuing approval for devices across a range of uses have been increasingly turning to the FDA for initial regulatory approvals. Many end up establishing and growing their operations in the U.S.

The preference for the U.S. in part reflects a much more positive view of the US regulatory process compared with more than a decade ago.

For example, a Stanford University survey of medtech companies published in 2010² showed only 16% of respondents had excellent or very good experiences with the FDA, compared with 75% in the EU . In comparison, the 2022 BCG/UCLA Biodesign survey indicated a dramatic change. About 62% of surveyed medtech executives found the FDA approval process for standard medical technology predictable, while only 22% said the same for the EU.

These data suggest that the steps taken by the FDA designed to expedite the development and approval processes are paying off. The Breakthrough Devices Program, for instance, offers companies enhanced opportunities to gain clarity on regulatory expectations and potentially accelerate their entry into the market. Such measures have positioned the FDA as a more innovation-friendly regulator, particularly for companies developing cutting-edge technologies. Indeed, 79% of the BCG/UCLA Biodesign survey respondents agreed that the FDA has responded well to advances in medtech innovation over the past decade, while only 13% disagreed.

The hard data underscores the FDA’s strides towards establishing pathways to get advanced technologies to market.

The strong market potential and smoother regulatory process will likely continue to draw medtech companies into the U.S. sooner than anticipated. As a result, many firms will face unfamiliar regulatory, corporate, and intellectual property issues and decisions. We will unpack these topics in more depth in our “Medtech Coming to America” series.

^[1] “Interstates and Autobahns: Global Medtech Innovation and Regulation in the Digital Age,” Boston Consulting Group and UCLA Biodesign. March 2022.
^[2] “FDA Impact on U.S. Medical Technology Innovation,” Makower, J., Meer, A., & Denend, L. November 2010.

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