MedTech Member Organizations Participated in Study that Reveals Negative Impact of U.S. Medical Device Review Process on Medical Technology Innovation

Thursday, November 18, 2010

SYRACUSE, N.Y.— MedTech, the hub of Upstate New York’s bioscience and medical technology industry, played a key role in a study released today that reveals challenges faced by the U.S. medical device industry in navigating the U.S. Food and Drug Administration.
According to the report, patients in Europe have access to American-made technologies two-years sooner than patients do in the U.S. because of growing regulatory delays and inefficiencies at the FDA.
MedTech was one of 10 state medical industry organizations contributing to the study conducted by researchers from Stanford University with support from the Medical Device Manufacturers Association and the National Venture Capital Association. A survey of more than 200 medical technology companies identified key challenges facing the U.S. medical products industry.
Key findings:
  • On average, innovative new devices are available to U.S. citizens two full years later than patients in other countries. In some cases, American patients wait as long as six years longer than patients elsewhere.
  • To bring low-risk devices to market, companies must spend $31 million--$24 million of which is spent navigating the FDA approval process.
  • To bring higher-risk devices to market, companies must spend $94 million --$75 million of which is spent navigating the FDA approval process.
  • Almost half the companies reported that 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.
According to Dr. Josh Makower, a consulting professor of medicine at Stanford University, medical device entrepreneur and co-author of the study, “The data show that the U.S. is at risk of losing its global leadership position in medical technology innovation.”
“MedTech is very concerned about the potential effect on the growth of the Bio/Med industry in New York. This important study quantifies the negative impact of our regulatory process on this critical sector,” said Heather Erickson, president of MedTech. “MedTech is happy to be part of this vital effort to identify these challenges and help forge a path for improving the regulatory environment for the Bio/Med industry.”  
The full report is available for download from MedTech at
The Bio/Med industry employs close to 130,000 New York state residents, with about 95,000 of those jobs located Upstate, according to the U.S. Department of Labor. There are more than 200 Bio/Med companies in Upstate New York—primarily small to mid-sized—70 percent of which are headquartered in the region. MedTech currently represents 86 member organizations from across Upstate New York.
MedTech is an active association of pharmaceutical, biotech, and medical technology companies, their suppliers and service providers, and research universities. We boost the growth and prosperity of our members by connecting them for collaboration, offering educational programs, sharing news and information, and advocating for the industry with government and leaders. Our mission is to develop the relationships, tools and programs that enable Upstate New York companies to bring tomorrow’s medical solutions to the healthcare marketplace. For more information, visit  

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