Understanding FDA Role in Med-Tech Innovation

by: Douglas Cress

The Medical Device Manufacturers Association (MDMA) 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.”

The study, which was supported by MDMA and the National Venture Capital Association, surveyed over 200 small and medium sized medical technology companies to examine the impact FDA regulatory processes have on innovation, patient care and job-creation.