2011 Annual Report

TO OUR MEMBERS

2010 was an unprecedented year for the medical technology industry.  Technological advancements to extend and enhance lives have never been more promising, and the challenges originating from Washington have never been greater.  While MDMA supported bi-partisan efforts to expand healthcare insurance for Americans and improve the delivery of care, the final law included provisions that we believe would adversely impact innovation, patient care and job growth.  Some of our major efforts this year included:

• Led the fight to oppose the medical device tax from the outset, and though unsuccessful, cut the of the tax in half, and continue to work for a full repeal
• Worked to shape comparative effectiveness research to focus on "clinical effectiveness", not "cost-effectiveness"
• Actively engaged FDA leadership, Congress and the IOM on the need for a more predictable, reasonable and transparent premarket review process
• Worked with Congress to dramatically improve the Patent Reform Act
• Continued our efforts to ensure that patients and caregivers have access to the best products at the best price by pushing for GPO reforms
• Created an alliance with more than a dozen state and regional based groups throughout the country to harness the collective efforts of the med-tech community
• Organized powerful studies and surveys that are being used to educate elected officials and policy makers, as well as the public on key issues

Growing concerns over the lack of predictability with the FDA was a major focus of MDMA in 2010.  MDMA helped organize efforts throughout the country to make sure our members' concerns were heard.  We also conducted a survey with the National Venture Capital Association (NVCA) that quantified the negative impact FDA policies were having on patient care and innovation.

To help confront all of these challenges, MDMA relied upon its growing membership to engage Members of Congress and Administration officials on key issues. MDMA also strengthened its team with the addition of two seasoned professionals.  Heather Rosecrans, the former Director of the 510(k) Staff, joined the MDMA team as its VP of Regulatory Affairs.  Heather will be advising MDMA staff and its members on best-practices to navigate the regulatory process and continue bringing innovative, life-saving products to the marketplace.  Brendan Benner, a former Capitol Hill staffer and member of numerous political campaigns, joined as the Director of Public Affairs, and has been instrumental in driving media coverage of our issues and leading strategic outreach efforts.

As always, thank you for your passion and dedication to improving patient care, as well as your support of MDMA.  Your involvement has never been more important. Together, we will continue to make our voices heard, and ensure an environment exists where patient care and innovation thrive.

If you are not a member of MDMA, I strongly encourage you to join this energetic and passionate organization to help our efforts to ensure the United States remains the global leader in medical technology innovation.

Sincerely,

Eamonn P. Hobbs
President & CEO, Delcath Systems, Inc. 

Chairman, MDMA

Mark Leahey

President & CEO, MDMA