Share This Page
Home > What's New (Live)What's New (Live) > Everything ElseEverything Else

New Report: U.S. Medical Device Review Process Marked by Inefficiencies and Delays

Friday, November 19, 2010

Patients in Europe have Access to American-made Technologies Two Years Sooner

American patients have to wait on average a full two years longer than their European counterparts for many life-saving and life-enhancing technologies made by U.S. medical device and diagnostics companies because of growing regulatory delays and inefficiencies, according to a new study released on 18 November.

Josh Makower, MD

“The data show that the U.S. is at risk of losing its global leadership position in medical technology innovation. Unpredictability and inefficiencies in the U.S. regulatory process are making it difficult for companies to get life-changing medical products into the hands of clinicians and patients,” said Josh Makower, MD, consulting professor of medicine at Stanford University, medical device entrepreneur, and one of the coauthors of the study.” As a result, patients in the United States are waiting years for access to medical devices already available in Europe. I am not aware of any evidence that shows this approval lag provides safer products for U.S. patients.”

This trend could have profound consequences for the U.S. economy. The domestic medical technology industry directly employs 357,000 people and indirectly accounts for another 1.6 million jobs. In 2006, the latest available data, the sector shipped products valued at $123 billion. The industry is largely made up of small start-up companies with an estimated 80% having fewer than 50 employees. These companies serve as the critical engines for innovation and economic growth.

Makower and coauthor Aabed Meer, with the support of the Medical Device Manufacturers Association (Washington, DC) and the National Venture Capital Association (Arlington, VA), surveyed over 200 small and medium-sized medical technology companies in order to evaluate the impact of the current FDA regulatory processes on innovation, and provide comparisons to Europe. For low- and moderate-risk devices, the process to navigate FDA took companies on average three months to two years longer for a green light than it did for a similar approval from European regulators. For higher-risk devices, the discrepancy was greater—the process in the U.S. took three and a half years, or five times as long as Europe, to grant approval.

By overwhelming majorities, companies reported that European regulatory authorities were more predictable and transparent than FDA. Almost half the companies reported that key FDA personnel responsible for reviewing their product changed during the course of the review and one-third reported that appropriate staff were not present at meetings between the companies and FDA to discuss review issues.

“FDA delays are costly to patients desperate for new treatments and to small, innovative companies that often don’t have the resources to withstand regulatory uncertainty,” Makower said. “It takes $31 million to bring a lower-risk device to market—$24 million of which is spent on FDA-dependent and related activities. For higher-risk products, the tab is even steeper—$94 million, with $75 million spent on stages linked to FDA. As a result, researchers and medical-device firms are increasingly considering leaving the United States and setting up shop abroad, taking valuable jobs and tax revenue with them.”

Illustrating this concern, the report cites Rodney Perkins, MD, a clinical professor of surgery at Stanford University and a founder of multiple medical device companies, who says, “In previous decades, we shipped manufacturing jobs offshore. Now we’re shipping knowledge worker jobs abroad. Once you export innovation jobs, those jobs won’t come back.”

“The current regulatory environment is putting our nation’s fragile medical innovation infrastructure at risk,” Makower added. “FDA and innovators share the common goal of improving patient care. To achieve this objective, FDA and industry must work together towards a reasonable and balanced regulatory process for new innovations. This will ensure that patients and clinicians have timely access to safe and effective products. Only then will the most cost-effective advances in medical care be delivered; and only then will the public health and our economy be best served.”


Related Links

Makower, Josh; Aabed Meer, and Lyn Denend. FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies. Mountain View, CA: Josh Makower, 2010; available from Internet: 

Slone, Kelly. “FDA Impact on Innovation Study Out Today.” NVCAccess [online] (18 November 2010): available from Internet:

“Powerful New Study Details the FDA Role in Med-Tech Innovation.” Medical Device Manufacturers Association [online] (18 November 2010): available from Internet:
Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report, Theresa Wizemann, ed. ( Washington , DC: Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Institute of Medicine, 2010); available from Internet:

"New Report: U.S. Medical Device Review Process Marked by Inefficiencies and Delays." InHealth, November 19, 2010.


© 2014 Institute for Health Technology Studies. All Rights Reserved
1319 F Street NW, Suite 400, Washington D.C. 20004-1122 | Phone: (202)783-0940 | Fax: (202)783-0944
Site Map | Contact Us | Support InHealth
PhotoBooks Panacea CMS Solutions