On June 14th and 15th, we attended the Medical Device Manufacturers Association (MDMA) Annual Meeting. The organization provides medical device entrepreneurs an opportunity to have their voices heard on the hill. Innovation in our industry generally comes from the smaller players and policy makers need to hear small companies' perspectives in order to foster such innovation.
The purpose of the meeting was two-fold. The first was to get device company leaders up on the hill speaking directly with members of Congress. The second was to share the views of a series of top-notch speakers on exceptionally relevant policy issues. We heard from Andrew von Eschenbach, MD, Acting Commissioner, Food and Drug Administration (FDA), who said his vision for the agency was to be a science-based, science-led organization that could facilitate and promote innovation, not just regulate. He wants FDA to be more transparent, more predictable, more efficient, more effective and more timely which is consistent with the numerous guidance documents they are publishing.
We also heard from Daniel G. Schultz, MD, Director, Center for Devices and Radiological Health who talked about emerging technology trends, the Critical Path Initiative, FDA staffing (who knew FDA spent 80% of its budget on people?) and the controversial Medical Device User Fee Modernization Act (MDUFMA).
Mark B. McClellan, MD, PhD, Administrator Centers for Medicare and Medicaid Services (CMS), described his mission for CMS as (1) providing a clear and predictable reimbursement environment (2) having payment accurately reflect value and (3) ensuring good evidence exists to support what works. He was very enthusiastic about Gainsharing (much to the dismay of MDMA which stands strongly against gainsharing arguing that it harms patient care and stifles innovation) and opportunities to collect better evidence to help patients.
Other meeting topics included reforming GPO practices, R&D commercialization strategy, post-marketing issues and recent developments in patent law. These subjects are extremely relevant for the medical device industry, and we will be writing about them in more depth over the coming weeks.
Overall, we were impressed by the caliber of speakers and the insight provided on both sides of the issues. If you work at a small device company and your organization isn't a member, we highly suggest looking into it. MDMA is working on behalf of our best interests in the policy world and they need our support and our voices need to be heard.
