Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents hundreds of research-driven medical technology companies. Mr. Leahey's responsibilities include advocating on behalf of the entrepreneurial sector of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and other federal and state agencies. He has lobbied for a more reasonable user fee for smaller companies, worked to open access to the hospital marketplace by challenging the exclusionary and anti-competitive nature of certain large group purchasing organizations (GPOs), as well as ensure that medical device technologies are reimbursed adequately. Mr. Leahey has been named one of the medical device industry's top lobbyists and sits on the Editorial Advisory Board of Medical Product Outsourcing. He is a member of the Massachusetts Bar and a graduate of Georgetown University, the Georgetown Law Center and Georgetown's McDonough School of Business.
About Us - Staff
Mark B. Leahey
President & CEO
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Thomas Novelli
Vice President of Government Relations
Thomas Novelli is currently the Vice President of Government Relations for the Medical Device Manufacturers Association (MDMA). Mr. Novelli joined MDMA after working on the Committee on Finance for former Chairman and Ranking Member, Senator Charles Grassley, for nearly four years. At the Committee, he worked on several areas directly affecting the medical device and pharmaceutical industries including Federal reimbursement, drug and device safety and approval, and fraud and abuse in the Medicare and Medicaid programs. Mr. Novelli conducted several high-profile investigations into the pharmaceutical and medical device industries including the investigations of the use of educational grants and off-label marketing, clinical research organizations, and conflicts of interest in the healthcare industry. He is currently working on issues facing the device industry, including ensuring adequate and timely reimbursement for new medical technologies, transparency issues involving manufacturers and physicians, and patent legislation currently before the Congress. Mr. Novelli holds a Master of Arts in Policy, with Honors, from the Catholic University of America and a Bachelor of Arts in Political Science from the University of Dayton. He is currently pursuing a Master of Business Administration degree from the Johns Hopkins University. |
Heather Rosecrans
Vice President of Regulatory Affairs
Heather Rosecrans brings more than 30 years of public health and medical device experience to MDMA. Rosecrans continues her commitment to public health at MDMA where she provides strategic consulting services and works with MDMA members to bring innovative devices to patients. Prior to joining MDMA, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements. Rosecrans started her FDA career as a biologist in the agency's Bureau of Medical Devices - prior to the formation of CDRH. In 1980, Rosecrans joined the newly organized CDRH Premarket Application (PMA) Staff. For the next seven years, she coordinated the administrative, scientific and regulatory review of PMAs, product development protocols and associated submissions. In 1987, Rosecrans joined the 510(k) Section of CDRH's Program Operations Staff (POS). In this role, Rosecrans served as a Consumer Safety Officer and was a key contact for CDRH and FDA on 510(k) matters. Rosecrans held this position until 1992, at which time she became Director of the 510(k) Staff. Rosecrans' accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA). Rosecrans' extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation's leading experts on the program. Rosecrans' tenure also allowed her to play a pivotal role in the program's development and reform. Since the program's inception in 1976, more than 120,000 products have been cleared via the 510(k) program. Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies. Rosecrans holds a Bachelor of Science in Biology from Pfeiffer College in Misenhelmer, NC. |
Brendan Benner
Vice President of Public Affairs
Brendan Benner is the Vice President of Public Affairs for the MDMA where he is in charge of communications, strategic outreach and grassroots development. Benner has extensive experience in the private and public sector, as well as working with non-profits. He began his career with the Archdiocese of Philadelphia’s Office of Public Affairs where he worked on education policy and other issues, interacting with elected officials and policy makers. He spent several years working in Congress, serving both as a Communications Director and District Director for former Congresswoman Melissa Hart (PA) and Congressman Jim Gerlach (PA) respectively. He oversaw and implemented aggressive media and outreach plans in these highly competitive congressional districts. During the 2008 presidential campaign, Mr. Benner served as the Pennsylvania Victory Communications Director for Senator John McCain. Most recently, he was the campaign manager for one of the most competitive open House seats in the nation. Mr. Benner is a member of the Pennsylvania Bar and a graduate of Georgetown University and Temple University’s Beasley School of Law. |
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Sheri DeVinney
Director of Operations and Executive Assistant to the President
Sheri DeVinney is MDMA's Director of Operations and the Executive Assistant to the President. She brings more than 20 years of operational management and accounting experience to our association. In her current role, she is responsible for all office operations, programs, membership and serves as the Executive Assistant to MDMA’s President and CEO. Prior to joining MDMA, she held positions in the medical device, insurance, and real estate industries. Sheri also served in the United States Marine Corp for four years prior to attending Coastal Carolina Community College where she studied business and accounting. |




