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
Vice President of Government Relations
Thomas Novelli is currently the Vice President of Government Affairs at the Medical Device Manufacturers Association where he manages a portfolio of policy issues for the organization. Tom joined MDMA after working on the U.S Senate Committee on Finance for former Chairman and Ranking Member Senator Charles Grassley for four years. At the Committee, Tom 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. Tom 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. Tom holds a Master of Business Administration (Finance), with honors, from the Johns Hopkins University, a Master of Arts in Government, with Honors, from the Catholic University of America and a Bachelor of Arts in Political Science, with Honors, from the University of Dayton.
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.
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. Mr. Benner is also a veteran of numerous Congressional and Presidential campaigns as well. Mr. Benner is a member of the Pennsylvania Bar and a graduate of Georgetown University and Temple University's Beasley School of Law.
Senior Advisor for International/Consultant
Ed Rozynski enjoys introducing medical device executives to health and hospital leaders in key markets, such as China, India, Brazil, Japan, Europe and U.S. Ed has served as a former U.S. trade negotiator and, also, has been a student of international health care systems for the past 30 years. Ed likes to use his knowledge and experience to help medical device companies, especially start-ups with their global pre-market strategy, including how to navigate regulatory, payment and purchaser systems in key global markets.
With senior health policy relationships in the U.S. and abroad, Ed is a successful advocate for favorable economic, market access and coverage and payment policies for U.S. medical device companies. Mr. Rozynski also periodically contributes to U.S government advisory councils at a Presidential and Cabinet-level on ways to improve U.S. competitiveness. Ed co-authored the trade, taxes and regulatory policy section of the 2012 Advanced Manufacturing Partnership (AMP) with America's top academic institutions and business organizations.
In October 2012, Ed helped expand by 30% the overall procedure payment when a small US medical device company's technology is used in German hospitals through improved coverage and coding. Ed has mapped the reimbursement coverage process in more than a dozen countries. Mr. Rozynski's council is often sought when a company is seeking avenues and places to promote their technology in the world's largest and fastest growing markets for medical technology.
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.
Associate, Policy & Outreach
Elliott Warren is a Policy & Outreach Associate at MDMA. Elliott first started with MDMA as an Administrative Assistant where he provided background research and also fulfilled administrative duties. Specifically, he researched implications at the state and federal level surrounding the implementation of the medical device tax provision included in the Affordable Care Act (ACA). He continues to provide background on a portfolio of policy issues as well as helps to maintain MDMA's communications with Capitol Hill. Elliott is also responsible for coordinating MDMA's business development efforts and assists with the Association's grassroots advocacy, outreach and public affairs campaigns. Prior to joining MDMA, Elliott worked in the government affairs divisions of two DC based lobbying firms and spent time on Capitol Hill in the office of Senator Thad Cochran (MS). Elliott is a graduate of the University of Mississippi's Trent Lott Leadership Institute where he received a Bachelor of Arts Degree in Public Policy & Leadership with a minor in History.
Porter byers joined MDMA in March 2013 as the team Executive Assistant. He is responsible for assisting the MDMA team and members with all office functions, membership, working groups and special projects. Porter comes to MDMA from Jeffrey J. Kimbell & Associates, where he worked in political affairs and policy research in the healthcare industry. Previously, he worked as a Constituent visitor Assistant for Senator Richard Burr (R-NC) after internships at the Heritage Foundation and on Capitol Hill. Porter graduated from Southern Methodist University with a double major in Political Science and International Studies.