This morning a study on the FDA approval process for medical technologies was released by Dr. Josh Makower, consulting professor at Stanford Universityand CEO of ExploraMed.  NVCA along with the Medical Device Manufacturers Association (MDMA) supported the study which surveyed more than 200 CEOs at medical technology companies in the United States.  The survey found that due to inefficiencies at the FDA, innovative new medical devices are available to U.S. citizens on average two full years later than patients in other countries. In some cases, American patients wait as long as six years longer than patients elsewhere.  The study cites specific challenges faced by small innovative medical device companies seeking FDA approval for their technologies.  In the end, both American patients and the U.S. economy are negatively impacted.

The NVCA has long been an advocate for FDA reform in hopes of making the approval process for medical technologies more predictable, transparent and efficient.  We commend this study for quantifying what we have been hearing anecdotally for some time.  We feel the FDA shares our commitment to improving the current approval path and look forward to working with them to ensure that U.S. patients have access to safe medical innovations in a more timely manner.

To view Dr. Makower’s full white paper click here

To view slides on the study, click here.

To view the NVCA statement on the study click here