WASHINGTON, DC––MAY 24, 2011––Two-thirds of small medical device and diagnostic companies––the drivers of innovation in the sector––are obtaining clearance for new products in Europe first, suggesting delayed market entry in the U.S., according to a comprehensive industrywide survey about FDA's 510(k) product review process by researchers at Northwestern University.
Large and small companies reported that unclear guidelines, inconsistent implementation, and lead reviewer turnover are contributing to increasing unpredictability of the process. Only 8% of survey respondents believe FDA's 510(k) product review process is the most predictable regulatory system, as compared with roughly two-thirds of respondents who stated that Europe's CE marking process is the most predictable.
For 98% of those surveyed, the predictability of regulatory requirements is a crucial factor in deciding whether to invest in developing a new product. According to lead researcher John Linehan, PhD, professor of biomedical engineering at Northwestern University, the U.S. regulatory system has been widely credited with ensuring high standards of patient safety and device effectiveness, while also facilitating innovation. But increasing uncertainty about the implementation of the 510(k) process—partly attributable to increases in device complexity—is posing challenges for FDA and industry that may lead the United States to experience a "brain drain" in the medtech sector.
"As FDA considers regulatory revisions, what's at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace," Linehan said.
Through an online survey of more than 350 professionals engaged in medical device development, researchers sought to determine what works well in the 510(k) process and how its implementation can be further strengthened. In turn, they aimed to provide insight into how U.S. companies are navigating the changing regulatory environment at home. Among key findings of the survey:
Respondents find the consistency and efficiency of FDA's review process a concern.
- Three-quarters of respondents (76%) found preparation requirements for a 510(k) submission to be uncertain or unclear; 72% felt that information requests from FDA reviewers went beyond the requirements established in guidance documents; and 59% reported no guidance documents existed for their devices.
- During the past three years, respondents experienced changes in the lead FDA reviewer for approximately 14% of their submissions; of those, 60% felt the change negatively affected the product review.
- More than two-thirds of all respondents reported that FDA requests had a significant impact on their financial resources.
Small companies are more likely to incur expensive and time-consuming difficulties in navigating the process.
- The development process for small companies—which are involved with new products twice as often as large companies—is significantly longer than for large companies (26.6 months versus 17.7 months).
- Small company respondents report an average total review time of 330 days, while those in large companies report 177 days.
Seeking regulatory clearance and market launch outside the U.S. is becoming increasingly common.
- Only 4% of respondents reported approaching FDA as the first regulator to discuss and plan their submission for a new device, while 80% initially approached EU regulatory bodies.
- In the device-specific portion of the survey, respondents said that 65% of devices were CE-marked before receiving FDA clearance.
- Data suggest that current U.S. review time is more than twice as long as in the EU (part of it attributable to differences in regulatory requirements between the U.S. and the EU).
Coinvestigator Jan B. Pietzsch, PhD, president and CEO of the technology consultancy Wing Tech Inc., and a consulting associate professor in Stanford University's Biodesign program and department of management science and engineering, emphasized that the survey offers both industry and FDA opportunities to improve the 510(k) pathway, and that collaboration is needed to secure the future of medical innovation in the United States and patient access to the safest and most-effective medical devices in the world. Among opportunities identified in the survey:
- Respondents stated that their companies could have improved the initial submission for 39% of applications submitted in the past three years.
- On average, respondents felt that 26% of FDA's follow-up questions should have been anticipated.
"The responses indicate that there may be opportunities for industry to better anticipate FDA's evidentiary needs during the regulatory process, as long as they are clearly stated and communicated," said Pietzsch. "Similarly, the process would benefit from FDA better training inexperienced reviewers on how to treat submissions consistently." He added that 92% of respondents perceived a correlation between inexperienced reviewers and more FDA questions.
The survey findings are timely, as FDA's Center for Devices and Radiological Health (CDRH) is weighing regulatory revisions that support innovation; bring important, safe, and effective technologies to patients quickly; and keep jobs in the United States. (See sidebar on how the Northwestern survey responses align with the CDRH's action plan of January 2011.) The agency has also commissioned the Institute of Medicine (IOM) to produce an independent review panel report, which is expected to be released this summer.
Interviews with more than 80 medtech experts from FDA and industry informed the survey's content. For the survey, investigators queried product designers and developers, entrepreneurs, academic physician inventors, and regulatory affairs professionals––all of whom have been involved with the submission of 510(k) products in the past three years.
The survey is part of a larger study, "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform." Over the next several months, investigators intend to expand on the survey findings by compiling case studies and performing a more in-depth examination of the U.S. and EU regulatory processes.
The survey builds on the investigators' previous InHealth-funded research with colleagues at Stanford that for the first time documented in detail the medical technology development process. That study, published in the June 2009 issue of the Journal of Medical Devices, found that almost half of all activities and decisions in the development process are affected by regulatory requirements.
The study is funded by the Institute for Health Technology Studies (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life.
About InHealth (www.inhealth.org)
Launched in 2004, the Institute for Health Technology Studies is a nonprofit research and educational organization supporting independent analyses of the social and economic effects of diagnostic and therapeutic medical devices.