Monday, November 22, 2010

NVCA Commends Makower Study on the FDA Impact on Med Tech Innovation

Contact: Emily Mendell, NVCA. 610-565-3904,

Today the National Venture Capital Association commended the release of a new study led by professor and entrepreneur, Dr.Josh Makower, entitled "FDA Impact on U.S. Medical Technology Innovation."

The study, which was the first of its kind and conducted with support from the NVCA and the Medical Device Manufacturers Association (MDMA), surveyed more than 200 medical technology company CEOs regarding their experiences with the Food and Drug Administration (FDA) approval process for new medical technologies. The study found that inefficiencies at the FDA have led to U.S. medical technologies being available in Europe on average two years sooner than in the United States.

NVCA President Mark Heesen stressed the importance of the study to U.S. patients and
the economy while committing to continue working with the FDA on improving the
approval pathway:

“This study quantifies, in no uncertain terms, the challenge that small medical
device companies have when seeking approval for their products in the United States,”
said Heesen. “The current approval path is paved with inefficiency and uncertainty for
our most important innovators, compelling them to launch their medical breakthroughs
overseas years before offering them here in the U.S. Not only does this environment hurt American patients who would benefit from these innovations sooner rather than later, but it also hurts our entire health care system and the economy. We feel strongly that there are meaningful changes that can be made at the FDA which would improve efficiency and transparency without compromising on safety. We will continue working with the FDA to explore these remedies and feel confident that officials are committed to long term solutions that will help advance important medical breakthroughs in this country.”

About NVCA

The National Venture Capital Association (NVCA) represents more than 400 venture
capital firms in the United States. NVCA's mission is to foster greater understanding of
the importance of venture capital to the U.S. economy and support entrepreneurial
activity and innovation. According to a 2008 Global Insight study, venture-backed
companies accounted for 12.1 million jobs and $2.9 trillion in revenue in the United
States in 2008. The NVCA represents the public policy interests of the venture capital
community, strives to maintain high professional standards, provides reliable industry
data, sponsors professional development, and facilitates interaction among its members.

The Medical Device Manufacturers Association (MDMA) also applauded the efforts by one of America’s leading med-tech entrepreneurs, Dr. Josh Makower, to examine the impact of the current regulatory environment on medical device innovation. Dr. Makower led a study that details how patients in Europe are getting access to new therapies an average of two years before patients in the United States due to regulatory challenges at the FDA.

MDMA President and CEO Mark Leahey noted the importance of working together to protect America’s leadership position in medical technology:

“This powerful study provides compelling evidence of what we have been hearing for years at MDMA: the current regulatory environment is adversely impacting innovation, patient care and job-creation here in the United States. We must all work together to ensure that the FDA’s dual mission to protect and promote the public health maintains a balance that supports innovation and improves the lives of patients.

MDMA members who participated in this study are at the forefront of developing new products to improve our quality of life. They are the small and mid-sized companies that are helping to turn around this economy, and ignite the entrepreneurial spirit that makes the United States so unique. It is critical to support their efforts to develop tomorrow’s medical advancements, and that American patients and workers are the beneficiaries of American innovation.”

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