MDMA 2005 Annual Meeting
May 17 - 18, 2005
The Madison Hotel
15th and M Streets, NW
Washington, DC 20005
Conference Recap / Photos / About the Annual Meeting / Agenda / Sponsors
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Lester M. Crawford, DVM, PhD, Acting Commissioner, Food and Drug Administration |
Mark B. McClellan, MD, PhD, Administrator, Centers for Medicare and Medicaid Services |
2005 MDMA Chairman's Award Recipient U.S. Representative Joe Barton (R-TX), Chairman of the House Energy and Commerce Committee |
On May 17th and 18th MDMA hosted a successful 11th Annual Meeting in Washington, D.C. Highlights of the two day event included:
Acting Commissioner Les Crawford addressed the attendees Tuesday morning (5/17) and discussed many important initiatives at FDA including MDUFMA. Dr. Crawford stated that he is open to discussing changes to MDUFMA including reforming the current system. A panel consisting of Congressional and industry representation followed Dr. Crawford’s remarks to discuss the need to reform MDUFMA in a responsible fashion.
Associate U.S. Attorney James Sheehan discussed potential areas of exposure for GPOs and large medical supply companies and the potential for an increasing number of cases. This is the second time in two weeks that a high profile enforcement agent has discussed the contracting practices of group purchasing organizations. On May 12th, Jon Leibowitz, Commissioner of the Federal Trade Commission addressed the American Bar Association and quoted a report stating “under certain circumstances these practices may be harmful to competition” and if they find the appropriate case, the Federal Trade Commission should pursue it.
MDMA honored House Energy and Commerce Chairman Joe Barton (R-TX) with the MDMA Chairman’s award. Outgoing Chairman of the MDMA Board of Directors, Chris Chavez, presented him with the award and thanked Chairman Barton for his strong and courageous leadership. Chairman Barton reiterated his support for innovative and entrepreneurial device companies and encouraged those in attendance to continue inventing better and safer devices for the health and well-being of all patients.
CMS Administrator Mark McClellan discussed the value of medicine and the importance of health care as CMS continues to implement the changes that resulted from the Medicare Modernization Act. Following his speech, a panel with representatives from CMS, ARHQ and FDA discussed the evolving challenges in federal evidence standards. Dr. Barry Straube, Acting Director of the Office of Clinical Standards and Quality at CMS, was very receptive to the concerns that additional data collection can have on small device companies and he assured the audience that “he is more open than ever to work with industry as collaborators.” He invited MDMA to come meet with him to discuss the membership’s concerns regarding coverage under protocol.
Overall, the meeting was a huge success and an excellent chance for the membership to hear from key federal officials on the issues surrounding the manufacturing of medical devices.
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Dr. Lester Crawford, Acting FDA Commissioner, delivers the FDA Commissioner's Update. |
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| Associate United States Attorney, Jim Sheehan discusses hospital group purchasing organizations (GPOs) during lunch. | |
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| Outgoing MDMA Chair, Chris Chavez, accepts an award for his superior leadership and service at a reception on Capitol Hill. LEFT: Incoming MDMA Chair Nancy Briefs MIDDLE: MDMA Executive Director, Mark Leahey | |
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| U.S. Representative Joe Barton (R-TX), Chairman of the House Energy and Commerce Committee, accepts the 2005 MDMA Chairman's Award at a reception on Capitol Hill. | |
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| Dr. Mark McClellan, CMS Administrator, updates MDMA Annual Meeting attendees on the very latest at CMS. | |
ABOUT the 2005 MDMA Annual Meeting
The MDMA Annual Meeting is a premier industry conference that brings medical technology executives together with senior officials from FDA, CMS, and Congress to discuss critical regulatory and legislative issues affecting innovative medical device companies. This year, attendees will hear directly from Acting FDA Commissioner Dr. Lester Crawford, CMS Administrator Dr. Mark McClellan, and Chairman of the House Energy and Commerce Committee, Representative Joe Barton (R-TX).
Approximately 125 private sector executives, consultants, and government officials will participate in this year's conference. Registration is open to MDMA members, non members, and press.
Who should attend? CEOs, Government Affairs, Legal/Consulting, Regulatory Affairs, Reimbursement, Sales and Marketing
Updated 5.13.2005
| TUESDAY 5.17.2005 | ||
| 8:00-9:00 AM | REGISTRATION & CONTINENTAL BREAKFAST Montpelier Foyer |
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| 9:00-9:30 AM | WELCOME & OPENING REMARKS Montpelier |
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| Mark B. Leahey, Esq., Executive Director, MDMA | ||
| Christopher G. Chavez, Chariman, MDMA and President and CEO, Advanced Neuromodulation Systems, Inc. | ||
| 9:30-10:30 AM | MEDICAL TECHNOLOGIES INNOVATION OUTLOOK: The prospects of medical device companies, both among investors and in the marketplace, have never been better. But getting to today's strong climate has been the product of challenging times over the past decade or so. A look at the past, present and future of the medical device industry. Montpelier |
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| David Cassak, Managing Partner, Windhover Information, Inc. | ||
| 10:30-10:45 AM | BREAK | |
| 10:45-11:15 AM |
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| Lester M. Crawford, DVM, PhD, Acting Commissioner, Food and Drug Administration | ||
| 11:15 AM-12:15 PM | FDA ISSUES ON THE HORIZON: This panel will discuss ways in which to improve MDUFMA after more than two years of experience with the program. Topics include user fees, the FDA review process, the appropriations outlook and more. Montpelier |
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| Panelists: | ||
| Steve Northrup, Health Policy Staff Director, Senate Health, Education, Labor and Pensions Committee | ||
| Paul Touhey, President and COO, Fujirebio Diagnostics, Inc. | ||
| Moderator: | ||
| Mark B. Leahey, Esq., Executive Director, MDMA | ||
| 12:15-1:30 PM | LUNCHEON KEYNOTE Mount Vernon |
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| James G. Sheehan, Associate United States Attorney | ||
| 1:30-2:45 PM | ACCESS TO INNOVATION: Hear the latest on the continuing efforts by Congress, GPOs and the medical device industry to ensure that patients and doctors have access to innovative, cost-effective technologies in the hospital marketplace. Montpelier |
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| Panelists: | ||
| David A. Balto, Partner, Robins, Kaplan, Miller & Ciresi | ||
| Seth Bloom, Counsel, Senate Judiciary Antitrust Subcommittee | ||
| Todd Ebert, President, Amerinet, Inc. | ||
| Jim McManus, Vice President-Finance, St. Joseph Health System | ||
| Moderator: | ||
| Mark B. Leahey, Esq., Executive Director, MDMA | ||
| 2:45-3:00 PM | PREPARING TO "HIT THE HILL" Montpelier |
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| Congressional Fly-In participants have the opportunity to ask any last minute questions and pick up "leave behind" packets for their Capitol Hill appointments. | ||
| 3:30-5:30 PM | CONGRESSIONAL FLY-IN House and Senate Office Buildings |
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Conference attendees head to the Hill to meet with their respective Senators and Representative to discuss issues affecting the innovative medical technology industry. *MDMA staff is available to coordinate Hill meetings on your behalf. If you are registered for the conference and interested in participating in the fly-in, email ejones at medicaldevices.org. |
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| 5:30-7:00 PM | CHAIRMAN'S RECEPTION HONORING REPRESENTATIVE JOE BARTON (R-TX), CHAIRMAN OF THE HOUSE ENERGY AND COMMERCE COMMITTEE Rayburn House Office Building, Room 2322 |
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| MDMA will present U.S. Representative Joe Barton (R-TX), Chairman of the House Energy and Commerce Committee, with the 2005 MDMA Chairman’s Award at a reception on Capitol Hill. MDMA is honoring Chairman Barton for his leadership in pro-innovation, pro-small business policymaking that has enabled MDMA member companies to better serve patients and caregivers in the US and abroad. | ||
| WEDNESDAY 5.18.2005 | ||
| 7:30-8:30AM | BREAKFAST PRESENTATION: How to leverage relationships with independent distributors and sales representatives Montpelier |
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| Presenters: | ||
| The Independent Medical Distributors Association (IMDA) represents the nation's premier providers of medical specialty sales, service and education. Learn how specialty distributors and reps can help manufacturers build a market for their innovative medical devices. | ||
| Rick Pfahl, Vice President Sales & Marketing Acute, Bovie Aaron Medical Corporation | ||
| Shawn Walker, Vice President, Bay State Anesthesia, Inc. | ||
| Presentation by the Health Industry Representatives Association (HIRA) | ||
Stephen M. Souder, Vice President Medical Products, Birchwood Labs, Inc. |
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Thomas Vollmer, CPMR, Owner/President, Provision Associates |
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| 8:30-9:30 AM | FEDERAL HEALTH CARE COMPLIANCE Montpelier |
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| Presenters: | ||
| Promoting Your Medical Device Before and After Clearance or Approval: Recent marketing and enforcement trends in direct-to-consumer advertising, promotion of off-label use, disease awareness communications, pre-approval promotional activities, and communications to investors | ||
| Ben Haas, Associate, Latham & Watkins LLP | ||
| John R. Manthei, Partner, Latham & Watkins LLP | ||
| Emerging Fraud and Abuse Compliance Issues for Device Manufacturers: New developments in law and administrative guidance, government enforcement activities, and changing industry practices | ||
| Eve M. Brunts, Partner, Ropes & Gray LLP | ||
| 9:30-10:15 AM |
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| Mark B. McClellan, MD, PhD, Administrator, Centers for Medicare and Medicaid Services | ||
| 10:15-11:30 AM | EVOLVING CHALLENGES IN FEDERAL EVIDENCE STANDARDS Montpelier |
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| Panelists: | ||
| Elise Berliner, PhD, Scientific Director, Director, Technology Assessment Program, Agency for Healthcare Research and Quality (AHRQ)*invited | ||
| Barry Straube, MD, Acting Chief Medical Officer and Director, Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services | ||
| Bram Zuckerman, MD, Director FDA Division of Cardiovascular Devices | ||
| Moderator: | ||
| Kathy Means, Partner, Patton Boggs LLP | ||
| 11:30-11:45 AM | BREAK | |
| 11:45 AM-1:00 PM | OFFENSIVE AND DEFENSIVE PATENT STRATEGIES: Obtaining and licensing strong patents and procuring clearance opinions Montpelier |
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| Presenters: | ||
| Linda Alcorn, Director, Sterne Kessler, Goldstein & Fox PLLC | ||
| Les Bookoff, Partner, Finnegan Henderson Farabow Garrett & Dunner LLP | ||
| Barbara McCurdy, Partner, Finnegan Henderson Farabow Garrett & Dunner LLP | ||
| 1:00-2:00 PM | LUNCH PRESENTATION Mount Vernon |
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| Anil N. Patel, P.E., U.S. Manager - Medical, Underwriters Laboratories | ||
Click on the logos below to learn more about our 2005 Annual Meeting sponsors.
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| Silver Sponsors | |
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| Bronze Sponsors | |
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