Survey: Most Companies Prioritize Overseas Product Launches

Three out of four medical technology companies debut their new products overseas before introducing them to the U.S. market due to high costs and unpredictable U.S. Food and Drug Administration (FDA) requirements, a survey has concluded.

A study funded by the Institute for Health Technology Studies (InHealth) of Carpenteria, Calif., found that 76 percent of companies went overseas with their new products over the last three years. Firms’ motivation for this exodus fell into three main categories: the cost of conducting clinical trials (cited by more than one in five, or 22 percent of respondents), quicker and easier regulatory processes outside of the United States (cited by another 14 percent of companies) and unpredictable premarket approval 510(k) requirements (cited by the majority of participants – 64 percent).

The study was conducted by John Linehan, Ph.D., a bioengineering professor at NorthwesternUniversity in Evanston, Ill. Linehan surveyed more than 350 professionals from device development companies closely involved in a recent 510(k) submission. The roughly 90-question anonymous electronic survey was completed by entrepreneurs, academic physician-inventors, product developers, and regulatory affairs experts.

In recent years, the 510(k) process has come under fire from many directions. Advocates of a more rigorous premarket review process say that current processes may permit unsafe devices to make their way onto market. But the device industry maintains that current processes are both unpredictable and slow, inhibiting patient access to medical technology.

The FDA has admitted to problems with the current 510(k) process, and in January, unveiled 25 changes to its highly-criticized program. Some of those changes include streamlining the “de novo” process (typically reserved for innovative, lower-risk products), publising guidance on product modifications and clinical trial data, developing a network of external experts to help the agency address scientific issues about new medical device technologies, and creating a new Center Science Council (CSC) to guide the agency in science-based decision making.

In July, the Institute of Medicine (IOM) released its own blueprint for overhauling the 510(k) process, claiming in a 246-page report that the program does not reliably evaluate device safety and effectiveness and therefore should be scrapped. The IOM’s report noted that the 510(k) clearance process—used by manufacturers to clear about 90 percent of medical devices for the U.S. market since its inception 35 years ago—“cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” Translation: data regarding the safety and effectiveness of previously cleared devices is insufficient—therefore, while previously cleared devices might be deemed similar to newer products, they offer no clues about the new products’ safety and effectiveness.

The InHealth survey’s conclusions contradict the IOM’s findings and provide additional insight into ways to improve the 510(k) process. “In spite of the IOM recommendation that FDA should abandon the 510(k) process, the results of this survey show that there is wide agreement among many experts on 510(k) issues about basic changes that could make this process work better and help America retain its position as the global leader in new medical technologies,” Linehan said. “The real question is exactly what the FDAcan and will do with this feedback.”

Some of the key findings from the InHealth survey include:

Device Classification and Premarket Review
While the IOMreport found the 510(k) process to be more “economical, faster and less burdensome to industry than the premarket approval application,” survey respondents found that increased testing requirements have made the average time from submission to approval effectively the same for the two processes. As a result, more firms – particularly smaller ones – launch their products in foreign markets.

FDAInfrastructure
Survey respondents agree with with the IOM findings that there is simply not enough staff at FDA to manage these applications in a timely manner, and suggest that insufficient training and expertise among the staff who are there is leading to repeated – and costly – requests for information already provided. Respondents further submit that inconsistencies and unpredictability in the approval process may be due, in part, to staff turnover and varying levels of expertise from reviewer to reviewer. Senior staff at FDA with longer histories of working with industry were viewed much more favorably.

Implementation
Lack of consistent or clear interpretation at FDA of intended use and indications for use is problematic according to both the IOM panel and industry survey respondents. A fuller understanding of these two terms would improve the efficiency of the process for both device companies and FDA reviewers.

Evidence Supporting 510(k) Submissions
The IOM panel and the survey respondents agree that FDA’s determination of need for pre-clinical and clinical data is inconsistent, and this process has changed the most over the past three years in comparison with other types of requirements. The survey further revealed that guidance documents issued by FDA are insufficient to help companies navigate the process, and don’t exist at all for many types of devices. Both situations pose difficulties for manufacturers.

De Novo Premarket Review
The study confirms the IOM finding that the De Novo review process is underutilized due to a number of factors, including lack of clarity in the process and undefined timelines. Industry finds the process further complicated and undesirable due to a perception that FDA staff discourage these applications.

Innovation and the Clearance Process
The regulatory environment is widely cited as the number-one factor in a company’s decision whether to develop a new product, according to the survey. The study authors suggest a slightly altered definition of innovation to that used in the IOM report, and cite the length of submission review times as a strong disincentive to innovate, especially for smaller companies.

The Medical Device Ecosystem
Lack of predictability in the 510(k) process is uniformly viewed as a barrier to venture capital investment in companies seeking approvals, and may be leading to companies opting for non-U.S. avenues to get their products to market. Predictability is further cited in the survey as the most critical metric for evaluating the efficacy of any changes to the 510(k) system, followed by “appropriate alignment of device risk and review intensity.”