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 will also discuss the impact of the recent US Supreme Court decision on federal preemption.

Kate Cook, Acting Associate Director for Regulation and Policy , CDRH

Dr. Diane Mitchell,CAPT USPHS, 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 will discuss 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 Michael Leavitt, Secretary, Department of Health and Human Service *invited

1:45pm - 2:45pm

REAL AND PERCEIVED CONFLICTS IN THE U.S. HEALTH CARE SYSTEM
This session will review activities related to Group Purchasing Organization reform, recent litigation cases as well as a review of the Physician Sunshine Act.

2:45pm - 3:00pm

PREPARING TO HIT THE HILL
Congressional Fly-In participants should remain in the general session following the "Real and Perceived Conflicts in the U.S. Health Care System" panel to ask any last-minute questions related to their Capitol Hill appointments and pick up “leave-behind packets” to give to the Members and staff with whom they meet. 

CONGRESSIONAL FLY-IN
House and Senate Office Buildings

Meeting participants attend Hill meetings with their respective Senators and Representative to discuss issues affecting the innovative medical technology industry.

When registering please indicate whether you will be participating.

5:30pm - 7:00pm

MDMA CHAIRMAN'S RECEPTION
MDMA will regognize Senator Boxer for her continued efforts to ensure that patients have timely access to safe and effective products

The Honorable Barbara Boxer, United States Senator *invited

NETWORKING BREAKFAST

8:10am - 9:00am

INTERNATIONAL OPPORTUNITIES AND CHALLENGES

China and India are booming, and Japan is still the largest medical device market in Asia. This presentation will discuss key business and regulatory updates in China, India, Japan, and several of the smaller Asian markets. 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

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 will discuss steps companies can take in complying with federal and state laws.

Tom Crane, Partner, Mintz Levin

Daniel F. Donovan III, Counsel, King & Spalding

Don Zarin, Partner, Holland + Kinight LLP

10:15am - 10:30am

NETWORKING BREAK

10:30am - 11:45am

PERSPECTIVES FROM INDUSTRY LEADERS
Executives will discuss issues and challenges facing medical technology companies at various stages of development including raising capital, going public and the acquisition process.

Mark Wan, Partner, Three Arch 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.

Shawn Bishop, Health Policy Advisor, US Senate Committee on Finance

Thomas Gustafson, PhD, Senior Health Policy Advisor, Arent Fox *invited

Marc Hartstein, Deputy Director, Division of Acute Care, CMS *invited

12:45pm - 2:00pm

LUNCHEON KEYNOTE: CMS UPDATE

Mr. Kerry Weems, Acting Administrator, CMS *invited

2:00pm

CLOSING REMARKS

Mark B. Leahey, Executive Director, MDMA