Study: Regulatory climate a primary determinant of med device makers market decisions

A new survey of stakeholders in the medical device industry confirms that regulatory requirements strongly sway manufacturers’ decisions around investments in, and development of, new products. Led by John H. Linehan, PhD, professor of biomedical engineering at Northwestern University in Chicago, the study suggests that, in the U.S., the FDA is unnecessarily hindering innovation.

At stake is the capability of companies “to attract investors in order to continue developing innovative, lifesaving products, and sustaining American competitiveness in the global marketplace,” said Linehan in a statement released by the Institute for Health Technology Studies (InHealth) in Washington, D.C., which funded the research.

InHealth said the research, published in the June edition of the Journal of Medical Devices, is the largest ever conducted on the 510(k) process, although its announcement did not disclose the size of the sample group.

Respondents said that, in almost nine out of 10 cases, FDA reviewers asked for additional information on a submission that went beyond what was required in guidance documents, according to InHealth.

The organization highlighted several key findings, including:

• More than two-thirds of manufacturers reported that predictability of the regulatory process is “critically important” for deciding in which country to launch their products.
• More than half of survey respondents (58 percent) cited regulatory requirements as one of the top three factors in investment decisions about proceeding with a new device—with 21 percent citing that as the top factor.
• More than two-thirds of respondents (66.3 percent) felt device-specific guidance documents were critical to preparing a successful submission, yet 58.6 percent stated that a device-specific guidance did not exist for their technology.

The authors said the FDA review process is almost twice as long as that of its European counterpart, the European Medicines Agency, for devices not requiring clinical data and almost three times as long for devices that do.

The study abstract indicated the data suggest that “improvement of regulatory process predictability needs to be a top priority for all stakeholders—especially FDA. Increasing the number of guidance documents available to industry, and ensuring that their content is timely updated to reflect current FDA thinking, could be one way to achieve this goal. Consistent implementation of the regulatory process and enhanced communications between sponsors and the agency could further contribute to improvements, along with efforts to provide additional training opportunities for reviewers and industry personnel.”

The abstract also noted that smaller manufacturers innovating novel medical devices are “particularly challenged by” the present regulatory process.

The full study—titled “Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience”—is available for purchase.

The study’s June 12 release followed two months after Congress’ nonpartisan, independent Government Accountability Office (GAO) confirmed that FDA has gotten a good deal slower at issuing yes or no judgments on manufacturers’ 510(k) applications—and a few weeks after both chambers of Congress, in a rare show of booming bipartisanship, cleared the Medical Device User Fee and Modernization Act (MDUFMA). This calls for industry to double the user fees it pays FDA in exchange for faster and more consistent reviews.

Meanwhile, less than a week after the study’s release, a former FDA commissioner co-authored, with the CEO of a medical-device startup, an op-ed in The Wall Street Journal deploring the current regulatory climate.

“With assets like the National Institutes of Health, cutting-edge academic medical centers, vibrant venture-capital networks, and a vast industrial infrastructure, the U.S. has no excuse not to lead the world in providing new medical devices,” they wrote. “American workers should be employed in this vital industry; American investors should profit from it; and most of all, American patients should benefit from it, in the form of better health and longer life. But that won't happen if we saddle the industry with regulations that are slow, costly and ineffective.”

While reader comments skewed strongly in support of the views expressed in the op-ed—unsurprisingly so, given the newspaper’s unapologetically pro-business bias—several expressed strong disagreement. “In the absence of pre-market clearance, there is no doubt that drugs, devices and whatnot would all get to the market more rapidly than they currently do,” one reader wrote. “The consequence, however, would surely be an armamentarium overflowing with products of dubious worth. Anyone care to bet their health and safety, or their lives, on what fraction would be safe, let alone actually effective?”