MDMA RECENT EVENTS
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The 2008 MDMA Annual Meeting was another huge success. We had a turnout of more than 150 medical technology executives and professionals. Speakers included Mr. Tommy Thompson, Former HHS Secretary; Dr. Phurrough with CMS; Kate Cook, Dr. Diane Mitchell and Donna Bea Tillman of CDRH; as well as the other representatives from Congress, FDA, CMS, and industry. MDMA was honored to have so many senior government officials provide their unique and valuable insight to our Annual Meeting participants. Understanding the impact of industry and government trends has never been more important; the interaction with these key decision-makers is imperative to ensure that the needs of medical device manufacturers are heard in Washington.
Read highlights, see photos and view the agenda.
10th Annual Coverage, Reimbursement and Health Policy Conference
On November 12 and 13, 2007 the Medical Device Manufacturers Association (MDMA) held its 10th Annual Coverage, Reimbursement and Health Policy Conference in Washington, DC. The Conference presented a unique opportunity for MDMA members and non members to interact with some of the leading stakeholders and decision makers within the reimbursement arena. Participants were treated to several in-depth presentations on basic Medicare reimbursement concepts, the international reimbursement landscape, the role of private investment and venture capital in developing reimbursement strategies, and the role of private payers of medical devices.
The program began with an afternoon dedicated to Reimbursement 101, a thorough review of some of the basic concepts of reimbursement including primers on coding, coverage and payment, investor strategies, and a review of fraud and abuse issues.
Premarket Approval (PMA) and 510(k) Premarket Notification Workshop
September 28, 2007
Palo Alto, CA
MDMA, in cooperation with BayBio, held a one-day workshop in Palo Alto, CA on September 28, 2007 titled, Premarket Approval (PMA) and 510(k) Premarket Notification Workshop. Attendees learned the regulations governing 510(k) and PMA premarket submissions from leading FDA attorneys, industry representatives, and FDA officials. This workshop is designed to help companies understand the technical requirements of submissions, provide practical advice on how to prepare them, help manage and maximize communications with FDA, avoid fraud and abuse in clinical trials, and devise a product reimbursement strategy. The program provided valuable insight from a variety of perspectives and gave companies considering submitting a 510(k) or PMA in the future the tools they need to prepare successful submissions.
2007 MDMA Annual Meeting, Celebrating 15 Years of Achievement 1992 - 2007
May 17-18, 2007
Washington, DC
The MDMA Annual Meeting, Celebrating 15 Years of Achievement 1992 - 2007 is a premier industry conference which brought executives from innovative medical technology companies together with healthcare's most influential and respected decision makers. The program will featured speakers from industry, Congress, the Food & Drug Administration, and the Centers for Medicare & Medicaid Services. Attendees included high-level medical technology executives, attorneys, consultants, and others seeking to learn more about trends in the industry.
View the agenda and sponsors.
MDMA in cooperation with Vector Resources, LC held a product commercialization workshop in Washington, DC on March 22, 2007. Participants interacted with leading healthcare executives who shared their real-world experience in successfully executing a wide range of product commercialization approaches. Attendees learned more than six proven strategies for the commercialization of medical devices, as well as discussed the ones best suited for various types of products and companies.
Click here to view the agenda.
MDMA hosted its 9th Annual Coverage, Reimbursement and Health Policy Conference in Washington, DC on November 8-9, 2006 at the Madison Hotel. This conference offered attendees the opportunity to hear from leaders in Medicare policy, including senior CMS officials, Congressional staffers, and reimbursement consultants. Through presentations and interactive sessions, over 100 attendees learned about evolving challenges in evidence requirements, how new legislation is affecting reimbursement, and strategies for obtaining speedy, adequate reimbursement for new technologies.
Click here to view the agenda and a list of our sponsors.
MDMA in cooperation with CHI, BIOCOM, and Latham & Watkins LLP held a one-day workshop in San Diego Califonia on September 28, 2006 titled Premarket Approval (PMA) and 510(k) Premarket Notification Workshop. Attendess learned the regulations governing 510(k) and PMA premarket submissions from leading FDA attorneys, industry representatives, and FDA officials. This workshop was designed to help companies understand the technical requirements of submissions, provide practical advice on how to prepare them, and help manage and maximize communications with FDA.
We will be holding this workshop again in 2007 for those companies considering submitting a 510(k) or PMA in the future. It will provide valuable insight from a variety of perspectives and give you the tools you need to prepare successful submissions.
Click here to read the agenda.
MDMA in cooperation with Vector Resources, LC and with local coordination provided by the Southern California Biomedical Council (SCBC) held a product commercialization workshop in Los Angeles on September 14, 2006. Participants interacted with leading healthcare executives who shared their real-world experience in successfully executing a wide range of product commercialization approaches. Attendees learned more than six proven strategies for the commercialization of medical devices, as well as discussed the ones best suited for various types of products and companies.
Click here to read the agenda.
2006 MDMA Annual Meeting
June 14th & 15th
Mandarin Oriental
Washington, DC
MDMA hosted its 12th Annual Meeting on June 14th and 15th at the Mandarin Oriental hotel in Washington, D.C. With more than 140 attendees and a host of distinguished speakers, it was MDMA’s most successful annual meeting to date. MDMA Chair Nancy Briefs, CEO of Percardia, Inc., reminded attendees of MDMA’s advocacy successes. “This organization began with just a small handful of entrepreneurial companies and a common mission: to advocate for innovation to improve patient care,” she said. “Today, we are a strong voice in Washington.”
Click here to read all of the details and to view pictures.
Product Commercialization Workshop: Succusseful Strategies for Getting Your Products to Market
MDMA in cooperation with Vector Resources, LC hosted its first Product Commercialization Workshop on March 10, 2006 in Burlington, MA.
Click here to read the full agenda
8th Annual Coverage and Reimbursement Conference
November 9 - 10, 2005
Washington, DC
MDMA hosted its 8th Annual Coverage and Reimbursement conference on November 9th and 10th at the Hyatt Regency on Capitol Hill. The two-day event was a big success as there were more than 100 people in attendance. The conference kicked off on Wednesday afternoon with an interactive Reimbursement 101 & Your Business Plan session hosted by Maren Anderson, President of MDA Consulting. Thursday included an opening address from Mark Miller, Executive Director of MedPAC, and then a series of panel discussions on subjects including trends in evidence development at CMS and FDA, payment factors in the prospective payment system, CPT and coding developments and pay for performance vs. device contract gainsharing. The day wrapped up with a Capitol Hill update on Medicare policy, presented by Joel White, Staff Director for the House Ways and Means Committee, Subcommittee on Health, and Pat Bousliman, Acting Director, Senate Finance Committee Democratic Health Staff.
Click here to view the full agenda and list of our sponsors.
Medical Device Workshop: What Every Medical Technology Company Should Know About the 510(k) Process
September 30, 2005
Burlington, Massachusetts
Click here to read the full agenda.
2005 MDMA Annual Meeting
May 17-18, 2005
The Madison Hotel, Washington, D.C.
Speakers:
Representative Joe Barton (R-TX), Chairman, House Energy and Commerce Committee
Elise Berliner, PhD, Scientific Director, Technology Assessment Program, AHRQ
Seth Bloom, Counsel, Senate Judiciary Antitrust Subcommittee
Lester Crawford, DVM, PhD, Acting Commissioner, FDA
Mark McClellan, MD, PhD, Administrator, CMS
Steve Northrup, Health Policy Staff Director, Senate HELP Committee
Jim Sheehan, Associate United States Attorney
Barry Straube, MD, Acting Director, OCSQ and Acting Chief Medical Officer, CMS
Bram Zuckerman, MD, Director, FDA Division of Cardiovascular Devices
*Partial listing
Click here to view the full agenda and list of sponsors.
Medical Device Workshop: What Every Medical Technology Company Should Know About the 510(k) Process
March 8, 2005
Costa Mesa, California
MDMA 2004 Medicare Coverage & Reimbursement Conference
November 9-10, 2004
The Madison Hotel, Washington, D.C.
MDMA hosted its 7th annual Medicare coverage and reimbursement conference on November 9th and 10th at the beautiful Madison Hotel in Washington, DC. Attendees discussed the Medicare challenges facing innovative medical technology companies with senior officials from the White House, Congress, the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Agency for Healthcare Research and Quality, the US Department of Health and Human Services and private sector experts. Panels focused on topics such as evidence requirements, payment issues, Medicare bidding and CPT codes to name a few. If you missed out this year, be sure to join us in 2005!
Medical Device Workshop: What Every Medical Technology Company Should Know About the 510(k) Process
September 30-October 1, 2004
Washington, D.C.
Speakers:
Karen M. Becker, PhD, President, Becker & Associates Consulting, Inc.
Tony Blank, Director of Corporate Regulatory Affairs, Boston Scientific Corporation
Carolyne R. Hathaway, Partner, Latham & Watkins, LLP
Mark Kramer, Director, Office of Combination Products
John R. Manthei, Partner, Latham & Watkins LLP
Heather Rosecrans, Office of Device Evaluation, Center for Devices and Radiological Health
Daniel Schultz, MD, Director of the FDA’s Center for Devices and Radiological Health
Ann C. Tunstall, PhD, Managing Consultant, SciLucent, LLC
Tracey Zoetis, MS, Managing Consultant, SciLucent, LLC
MDMA
International Reimbursement Conference Attracts Diverse Range
of Speakers and Interests
On June 21, 2004, a diverse group of international speakers
and experts on Germany, Japan, China and the United Kingdom
painted a clear picture for MDMA members on how to secure
medical technology reimbursement in their particular country
during MDMA's International Conference in Washington, D.C.
For more information on our events, please email Erin Jones or call 202.349.7172.