According to a poll from Boston Consulting Group, the United States has surpassed the European Union as the most important market for medical device makers, with 89 percent of MedTechs planning to prioritize the US Food and Drug Administration (FDA) approval in the future.
MedTech Manufacturer’s Executives Respond to BCG’s Poll
Boston Consulting Group (BCG), which worked with UCLA Biodesign to present data from a survey of 104 senior executives, said the shift is being driven by the EU’s “complex and unpredictable” Medical Device Regulation (MDR). The MDR took effect in mid-2021, making obtaining a CE mark more difficult.
The EU’s MDR “is killing innovation,” stated the European cardiac device business CEO who responded to the study.
The Appeal Of The European Market Is Now Declining
The decline in the EU’s appeal has occurred at a time when the FDA is courting the MedTech industry. Only 34% of respondents say the EU has adapted adequately to the changes brought on by digital technology, while two-thirds of respondents believe the FDA has. According to BCG’s study based on survey data, the FDA has “spent extensively to keep pace with digital changes” and the United States “has emerged as the go-to-market for worldwide launch.”
European Approach vs United States Approach
There is a significant difference in the approach that regulators on both sides of the Atlantic seem to be using nowadays. This is leading to a shift in the industries’ priorities.
Europe Is Redefining Requirements
Regulators on both continents have shifted their stance on MedTech in recent years. The most significant developments have occurred in the European Union, where the MDR and the In Vitro Diagnostic Regulation are redefining what it takes to bring pharmaceuticals to market in the region.
At the same time, the FDA has set a goal of making the United States a priority market for device developers.
The FDA Is On Track To Make The US The Priority Market
According to the FDA’s most recent evaluation, this leads to the current situation that nearly two-thirds of manufacturers of novel technological devices expect to introduce their goods to the United States first. Either just in the US or in tandem with other key markets. The BCG research adds to the growing body of evidence suggesting the FDA is on track to meet its goal.
The EU Now Has Fallen Behind Japan And China
The shift in focus from Europe to the United States appears to be due to what Europe has done to alienate the business as much as what the FDA has done to woo it. The EU has now fallen behind Japan and China on the list of priority markets for 23% of CE-marked companies, suggesting concerns about the impact of MDR and other considerations.
Europe Alienates MedTech Businesses, US Adapts To MedTech Businesses
“Respondents overwhelmingly view new MDR rules as complex and unpredictable, making it less appealing to develop and launch novel products in Europe. Other factors, including Brexit and intense reimbursement pricing pressure, may also reduce the attractiveness of pursuing the CE mark,” the BCG report states.
Only 22% of those polled believed the EU regulatory confirmation process for conventional medical devices is predictable. The United States’ percentage was 62 percent. Although the FDA still has space to improve, with just 33% of respondents believing its digital product pathway is predictable, there was widespread approval for some of its important objectives and a belief that it currently offers a clearer path to market than the EU.
According to the study, 79 percent of respondents strongly agreed or somewhat agreed that the FDA is effectively responding to medical improved technology. When it comes to artificial intelligence and machine learning, executives polled believe US regulators have a significant advantage.
AI/ML Products Require a High Level Of Competence From Reviewers
According to the BCG report, MedTech companies are rapidly developing AI/ML products (Artificial Intelligence / Machine Learning)
“More than half of the FDA’s 343 approvals of these kinds of products since 1997 were in 2019 and 2020. Because they are creative, these items require a higher level of competence from reviewers as well as more regulatory clarity for businesses“, according to the report.
The FDA’s breakthrough device designation program was praised by survey respondents, with 88 percent saying the guideline is at least somewhat clear and 75 percent believing it will lead to quicker patient access. More than half of those polled felt the program encourages more flexible research design.
Information of interest:
- Summary of the survey, from Boston Consulting Group: For Cutting-Edge Innovations, the US Pulls Ahead of the EU in Medtech Regulation
- Official website of the FDA
- Text MDR
- EU MDR explained