AnnualMeetingAgenda08

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PHOTOS


(from left to right) Mark Leahey, MDMA Executive Director Tommy Thompson, Former Secretary, Department of Health and Human Services Cynthia Fitzgerald, President, DMSG, Inc. Joe Kiani, MDMA Board Chairman, Chairman & CEO of Masimo Corp.	Michael Bell and Andrew Stuart, of R-Squared, demonstrate their compliance and reimbursement software for attendees.

Attendees participated in a multitude of panels and discussions regarding many facets of the future of the medical device industry.	CDRH Update and Other Key FDA Issues panel speaker Kate Cook addresses attendees.

The Honorable Tommy Thompson, Former Secretary, Department of Health and Human Services, gave the Keynote Address.	Patric Kallman, CEO, Vasco Advisors, demonstrates flexibility as he speaks amidst glowstick lighting during a 30 block power outage.

HIGHLIGHTS From This Year's Program

STATE OF THE MEDICAL DEVICE INDUSTRY

The 2008 Medical Device Manufacturers Association (MDMDA) Annual Meeting kicked off with an outstanding presentation by David Cassack of Windhover Information. Cassack highlighted the prevailing investment and merger trends within the device industry, citing that for the most part, a strong and favorable environment for emerging medical technologies exists. Cassack also discussed some of the possible challenges to investment in the device industry in the coming years including various regulatory and reimbursement hurdles.

CDRH UPDATE AND OTHER KEY FDA ISSUES

MDMA attendees received an update on Center for Device and Radiological Health (CDRH) issues from key government leaders including Kate Cook, Acting Associate Director for Regulation and Policy at CDRH, Dr. Diane Mitchell, CAPT. USPHS, Acting Associate Center Director for Postmarket Operations at CDRH, and Donna Bea Tillman, PhD, Director, Office of Device Evaluation at CDRH. Cook provided an insightful overview of the Food and Drug Administration Amendments Act (FDAAA) of 2007 and what the implications are for device manufacturers. Dr. Mitchell provided information to attendees regarding FDA’s efforts with respect to the post-market review process. Dr. Tillman provided attendees an overview of what to expect with the interactive review process.

THE CHANGING LANDSCAPE OF THE U.S. PATENT SYSTEM

Current challenges facing the US patent system made for an interesting and fruitful discussion during the Annual Meeting. Les Bookoff, Partner at the law firm Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, provided a poignant summary of best practices medical device companies should be aware of given the changing landscape of the patent system. Steve Jensen, Partner at Knobbe Martens Olson & Bear LLP, presented an overview of recent case law affecting intellectual property as well as highlighted potentially harmful provisions in the proposed Patent Reform Act (PRA). Jensen was also honored for his continual efforts on the PRA on behalf of MDMA.

LUNCHEON KEYNOTE

Former Health and Human Services Secretary and Former Wisconsin Governor Tommy Thompson delivered the keynote address at the 2008 MDMA Annual Meeting. Secretary Thompson focused his address on some of the looming issues affecting the health care system, including the expected shortfalls in the Medicare and Medicaid programs. Secretary Thompson also spoke to the negative consequences and anticompetitive nature of group purchasing organizations (GPO), citing how the proliferation of these entities will adversely affect healthcare spending by not enabling providers to always get the best product at the best price.

REAL AND PERCEIVED CONFLICTS IN THE U.S. HEALTH CARE SYSTEM

Cynthia Fitzgerald, a former GPO employee turned whistleblower, spoke to attendees about how perverse incentives within the GPO model are leading to substantial fraud, waste and abuse within the Medicare program. Fitzgerald was most recently featured in a front page article in the New York Times Business section highlighting her pending whistleblower case which alleges millions of Medicare dollars lost to fraud by the GPOs. The Panel was rounded out by Mark Leahey, Executive Director of MDMA, who highlighted the recently proposed Physician Payment Sunshine Act and what implications the legislation could have for small medical technology companies.

INTERNATIONAL OPPORTUNITIES AND CHALLENGES

The International Opportunities and Challenges Panel provided attendees with a perspective of what to expect within international markets. Jennifer Loffredo International Trade Specialist, Global Healthcare Team Leader, U.S. Commercial Service, at the U.S Department of Commerce, discussed some of the ways in which the Commerce Department may be helpful expanding in overseas markets. Patrick Kallman, PhD., CEO of Vasco Advisers, described his experience developing business and strategies for medical technology companies in the European marketplace. The Panel was concluded by Ames Gross who shared his expertise of the Asian-Pacific marketplaces and described the current climate for medical device export.

KEY FRAUD AND ABUSE ISSUES IN THE MEDICAL TECHNOLOGY INDUSTRY

Medical device companies are facing a changing environment with respect to government enforcement oversight of several facets of the manufacturer-physician relationship. Tom Crane, Partner at Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo spoke about recent enforcement actions against medical device companies by the Department of Justice. Dan Donovan, Counsel at the law firm of King & Spalding, provided insight into the growing practice by Congress to use its oversight authority to specifically examine individual device companies and what the activity means for future legislation. The Panel was concluded by Mike Bell, President of R-Squared who provided an overview of compliance issues between manufactures and physicians as well as offered insight into solutions to manage these relationships.

PERSPECTIVES FROM INDUSTRY LEADERS

Several prominent leaders in the device industry shared their experiences at the MDMA Annual Meeting. Joe Kiani, Chairman and CEO of Masimo Corporation, and MDMA Chairman of the Board, talked to participants about his experiences of taking Masimo public by discussing the relevant issues associated with his initial public offering. Chris Chavez, President of ANS, discussed his company’s experience of being acquired by St. Jude by highlighting some of the key aspects of the transaction and what it meant to both companies.

KEY REIMBURSEMENT ISSUES

Meeting participants had the opportunity to listen to some of the current reimbursement issues and challenges facing medical technology companies. Allison Shuren, Partner at the law firm of Arent Fox, presented an overview of what device companies seeking reimbursement can expect in the coming years. Miechal Lefkowitz, an Analyst at the Division of Acute Care at the Centers for Medicare and Medicaid Services (CMS) discussed the agency’s proposal for charge compression outlined in the most recent inpatient proposed rule. The panel concluded with Thomas Novelli, MDMA’s Director of Federal Affairs, discussing ongoing issues associated with comparative effectiveness research.

LUNCHEON KEYNOTE: CMS UPDATE

Steve Phurrough, MD, Director of the Coverage and Analysis Group at CMS, discussed general issues the agency is pursuing in the coming years. Dr. Phurrough also discussed some of the more recent actions taken by CMS and what it means for reimbursement for medical technologies. TOP

AGENDA(last updated 6.11.2008)



WEDNESDAY, June 11th

6:00 - 8:00 pm	NETWORKING RECEPTION

	Hosted by Crowell & Moring
	Meeting attendees networked with medical technology executives, government officials and other industry leaders while enjoying a beautiful view of the Nation's Capitol from the Crowell & Moring rooftop terrace.


THURSDAY, June 12th


8:15am - 8:45 am	REGISTRATION

8:45am - 9:00 am	WELCOME AND OPENING REMARKS
	Mark B. Leahey, Executive Director, MDMA Joe Kiani, Chairman and CEO, Masimo Corporation

9:00 - 10:00 am	OPENING BREAKFAST: STATE OF THE MEDICAL DEVICE INDUSTRY
	David Cassak, Managing Partner, Windhover Information

10:00am - 11:15am	CDRH UPDATE AND OTHER KEY FDA ISSUES An update on key CDRH issues including implementation of the Food and Drug Administration Amendments Act (FDAAA) of 2008 (interactive review and clinical trial registry database) and post market activities. The panel discussed the impact of the recent US Supreme Court decision on federal preemption.
	Kate Cook, Acting Associate Director for Regulation and Policy , CDRH Diane Mitchell MD, Acting Associate Center Director for Postmarket Operations, CDRH Donna Bea Tillman, PhD, Director, Office of Device Evaluation, CDRH, FDA John Manthei, Partner, Latham and Watkins


11:15am - 11:30am	NETWORKING BREAK

11:30am - 12:30pm	THE CHANGING LANDSCAPE OF THE U.S. PATENT SYSTEM Panelists discussed recent developments impacting the patent system including the Patent Reform Act, the PTO rulemaking authority, and recent US Supreme Court decisions.
	Les Bookoff, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. Steve Jensen, Partner, Knobbe Martens Olson & Bear LLP

12:30pm - 1:45pm	LUNCHEON KEYNOTE
	The Honorable Tommy Thompson, Former Secretary, Department of Health and Human Services

1:45pm - 3:00pm	REAL AND PERCEIVED CONFLICTS IN THE U.S. HEALTH CARE SYSTEM This session reviewed activities related to Group Purchasing Organization reform, recent litigation cases as well as a review of the Physician Sunshine Act.
	Mark B. Leahey, Executive Director, MDMA Cynthia Fitzgerald, President, DMSG, Inc. Blake Rodgers MD, President, Spine Midwest Research, Inc.

3:00pm - 3:15pm	PREPARING TO HIT THE HILL

3:30pm - 5:30pm	CONGRESSIONAL FLY-IN House and Senate Office Buildings Meeting participants attended Hill meetings with their respective Senators and Representative to discuss issues affecting the innovative medical technology industry.

5:30pm - 7:00pm	MDMA CHAIRMAN'S RECEPTION Attendees networked with medical technology executives, government officials and other industry leaders. MDMA will honored Senator Barbara Boxer for her continued efforts to ensure that innovative, entrepreneurial companies have the ability to deliver lifesaving technologies to patients.


FRIDAY, June 13th


7:30 - 8 :00am	NETWORKING BREAKFAST

8:00am - 9:00am	INTERNATIONAL OPPORTUNITIES AND CHALLENGES This presentation dicussed key business and regulatory updates in China, India, Japan, and several European countries. Topics to be covered include; product registration, business opportunities and trends, and common pitfalls to avoid. Real case studies will be utilized to emphasize key points.
	Ames Gross, President and Founder, Pacific Bridge Medical Patric Kallman PhD, CEO, Vasco Advisers Jennifer Loffredo, International Trade Specialist, Global Healthcare Team Leader, U.S. Commercial Service, U.S Department of Commerce

9:00am - 10:15am	KEY FRAUD AND ABUSE ISSUES IN THE MEDICAL TECHNOLOGY INDUSTRY With increasing government enforcement activity in the medical device industry, panelists dicussed steps companies can take in complying with federal and state laws.
	Michael Bell, Managing Member, R-Squared Tom Crane, Partner, Mintz Levin Daniel F. Donovan III, Counsel, King & Spalding

10:15am - 10:30am	NETWORKING BREAK

10:30am - 11:45am	PERSPECTIVES FROM INDUSTRY LEADERS Executives dicussed opportunities and challenges facing medical technology companies at various stages of development including raising capital, going public and the acquisition process.
	Guy Nohra, Co-Founder & Managing Partner, Alta Partners Joe Kiani, Chairman & CEO, Masimo Corporation Chris Chavez, President, ANS Inc., A St. Jude Medical Company

11:45am - 12:45pm	KEY REIMBURSEMENT ISSUES Discussion of key reimbursement issues in 2008 including charge compression in the inpatient setting and comparative effectiveness research.
	Miechal Lefkowitz, Analyst, Division of Acute Care, CMS Allison Weber Shuren, Partner, Arent Fox

12:45pm - 2:00pm	LUNCHEON KEYNOTE: CMS UPDATE
	Steve Phurrough,MD, Director, Coverage and Analysis Group, CMS

2:00pm	CLOSING REMARKS
	Mark B. Leahey, Executive Director, MDMA
	TOP