Guest Blogger Mark Leahey of MDMA discusses SBIR

My name is Mark Leahey, and I am the Executive Director of the Medical Device Manufacturers Association (MDMA).  MDMA is a national trade association representing innovative, entrepreneurial medical technology companies across the country.  Our mission is to ensure that patients have timely access to the latest advancements in medical technology, most of which are developed by small, research-driven medical companies.

With advancements in science, increasing regulatory requirements and market access challenges, significant investments from the government and venture capital are often needed to develop these life enhancing and life sustaining technologies. 

The majority of the most innovative advances in medical technology over the past twenty years have been developed by small, entrepreneurial medical companies.  These technologies are continually advancing and improving the health care for many Americans every day. At the same time, these innovative products are reducing long-term health care costs by improving outcomes, reducing hospitalization time and increasing productivity.

One of the cornerstones of government investments in small medical technology companies has been the SBIR program.  However, as you are aware, the Small Business Administration (SBA) implemented a change that significantly worsened the landscape of the public-private partnership envisioned by the SBIR program.  As a result, many promising technologies from smaller companies did not receive SBIR support, and patients suffered as a result.   The Medical Device Manufacturers Association would like offer the following recommendations that will help reestablish the program’s success.

1)  Reauthorization should include language — similar to that passed in H.R. 3567 — to restore the participation of venture-backed companies.  This will serve to provide SBIR grants to the most promising technologies which are likely to provide more patients with access to life-saving medical devices.

2)  Increase the dollar amounts of the Phase I and Phase II awards, given increasing development costs and to provide a greater incentive for companies to participate in the program.

3)  Provide agencies with more flexibility in administering the SBIR program.  Specifically, we believe it would be helpful to agencies if a small percentage of the SBIR set-aside could be used for activities such as conferences aimed at helping small businesses to compete successfully; commercialization assistance programs to help companies transition to the marketplace; and improved systems for assessing program effectiveness