In the early 2000s, when medtech companies had new devices they wanted to pass the regulatory process and bring to market, they turned to Europe.
But industry sentiment has shifted dramatically over the past decade as companies shined before U.S. regulators, according to a report released in March by Boston Consulting Group and UCLA.
“In fact, most companies now actually find U.S. regulation not only convenient, but more consistent with driving innovation faster and getting to market faster,” Gunnar Trommer, a partner at BCG and one of the report’s authors, said in a Zoom interview .
However, according to reports, the situation is not entirely optimistic 48 page report. Titled “Interstates and Highways: Global Healthcare Technology Innovation and Regulation in the Digital Age,” it is based on a survey of 104 company leaders.
While U.S. regulatory processes have improved, executives see the country’s reimbursement policy as a new barrier to innovation. They also worry about whether regulators can keep up with the explosion of medtech products that incorporate artificial intelligence and machine learning.
Nonetheless, the report paints a picture of U.S. Food and Drug Administration This has become more open to digital and technological innovation through a series of changes in policies and programmes. Nearly four-fifths of respondents, or 79 percent, agreed that the FDA “responds well to advances in medical technology,” according to the report. Eighty-nine percent said they would prioritize regulatory approvals in the U.S. over approvals in other countries.
“The FDA has significantly outperformed its international peers, and interesting data from this study shows that the U.S. has emerged as the most hospitable market for the emerging digital health product segment,” the report states.
The findings contrast with a 2010 study that showed Europe was the preferred regulatory pathway between 1999 and 2009, according to the BCG/UCLA report.
FDA’s view of improvement stems from several policy and program changes. These include the 2007 reauthorization of the Medical Device User Fee and Modernization Act, which increased funding for the agency and set a stricter timeline for decision-making. Executives in the investigation also cited the FDA’s plans to expedite reviews of so-called breakthrough devices, as well as guidelines for devices that combine artificial intelligence and machine learning.
Meghna Eichelberger, a partner at BCG, said: “These are all the moves the FDA has come up with over the past few years that have greatly simplified the process and, I would say, have made it even more difficult to bring digital and more of these innovative products to market. Predictable,” and co-author of the report, said in a Zoom interview.
Still, startups with less cash to burn remain relatively frustrated with the U.S. regulatory process, the report said. “Usually with only a few months of cash on hand, small companies still face significant challenges in dealing with FDA officials whose time horizons often do not match their own,” the report’s authors wrote.
America’s progress stands in stark contrast to the complexities of Europe.Executives’ new take on the African continent Medical Device Regulations, or MDR. They used the word “trouble and uncertainty”. Describe the MDR registration and approval process.
“These sentiments were expressed most strongly by small companies, while some executives at multinational medtechs were more cautious, speculating that MDR could indeed increase the average product in the EU market by reducing the number of underfunded new entrants,” the report said. quality.” .
Executives also cited new complications from Brexit, which has cut off one of Europe’s biggest markets — the U.K. — from the European Union. Slightly more than half, or 52 percent, of executives surveyed said their companies would prioritise approvals in Europe due to the risks and rewards of the market, the report said.
The main focus of the industry in the U.S. right now is reimbursement policy. Executives believe it has failed to keep pace. For example, they cite the Biden administration’s decision to sever the link between breakthrough device designation and reimbursement from the Centers for Medicare and Medicaid Services, which oversees the administration’s efforts to provide seniors, low-income people and people with disabilities. health insurance plan.
Nearly two-thirds, or 63 percent of executives surveyed, believe the reimbursement path for digital health products in the U.S. is unpredictable, compared with 45 percent for traditional products, the report said.
“Leaders have made broad calls for greater coordination between regulators and reimbursement agencies and the creation of a separate reimbursement classification for digital products,” the report’s authors wrote.
Photo: Waldemarus, Getty Images
