With a record turnout of nearly 175 medical technology executives and professionals, the MDMA 2009 Annual Meeting was a success.  The meeting provided an opportunity for attendees to hear and discuss some of the most critical issues of concern to device manufacturers within the current legislative and regulatory environment.

Attendees were first treated to a cocktail reception featuring Mark McClellan, MD, PhD, Director, Engelberg Center for Health Care Reform at the Brookings Institution and Leonard D. Schaeffer Chair in Health Policy Studies.  McClellan, also a former FDA and CMS commissioner, talked about efforts by the Administration and Congress to enact broad-based healthcare reform.

The Meeting program kicked off with an overview by industry expert David Cassak, Windhover Information's Managing Partner.  Cassak described the current economic outlook for the industry, highlighting that the current economic environment has dampened the industry slightly (although not as severely as other industries).  Cassak also stated that there may be a tendency for investors to focus more on early and late stage deals for device financings.

The first panel of the day, Gaining Access to Capital in Challenging Times, offered a unique perspective about financing device investments within a challenging economic environment.  Casey McGlynn, Chairman Life Sciences Group, Wilson Sonsini Goodrich and Rosati, highlighted the current environment for device investors and what companies can expect moving forward.  Similar sentiments followed with Ryan Drant, General Partner, New Enterprise Associates, who also stressed that the current environment has made it challenging for device companies seeking investors, but stated there are still opportunities.  The panel closed with a government perspective about accessing capital.  Lenka Fedorkova, PhD, Assistant Manager for the SBIR/ STTR Programs, National Institutes of Health (NIH) discussed the numerous opportunities that exist for medical technology companies to participate and compete for SBIR grants from the NIH.

While Congress is discussing legislation that would bring dramatic change to the patent system, Annual Meeting participants heard from leading experts in the field about the potential impact of current legislation.  Steve Jensen, Partner at Knobbe Marten discussed recent Supreme Court decisions affecting patent law and described some of the most impactful provisions of the current patent legislation.   Eb Bright, General Counsel at ExploraMed, also discussed the current legislative proposals and stressed the negative impact that certain provisions of the legislation would have on small, innovative medical device manufacturers.  The panel closed with Andrew Hirshfeld, Acting Deputy Commissioner for Patent Examination Policy, U.S. Patent and Trademark Office.  Hirshfield provided an overview of the USPTO and discussed some of the challenges the office is facing, including an overwhelming backlog of patent applications.

The Luncheon Address on the first day of the meeting was given by Jack W. Lasersohn, General Partner, The Vertical Group and Robert Kieval, Executive VP and Chief Technology Officer, CVRx.  Laserohn and Kieval discussed the MDMA and National Venture Capital Association’s recent white paper entitled, Medical Technology and Venture Capital: A Fruitful yet Fragile Ecosystem.  The session highlighted key issues identified in the MDMA/NVCA white paper exploring the relationship between venture capitalists and emerging medical technology companies. Both Lasersohn and Kieval discussed the critical innovations that have resulted from these interactions and the impact certain policies may have on the future of innovation.

Daniel G. Schultz, MD, Director for the Center for Devices and Radiological Health, FDA, HHS, discussed the current environment at CDRH as well as about the pace of innovation occurring in the industry.   In addition to speaking about the regulatory functions the Agency performs. Schultz also discussed the current trend of the device industry becoming more globalized.

Dr. Schultz’s presentation was followed up by a perspective of current FDA issues from a current and former Capitol Hill staffer.  Keith Flanagan, Minority Health Counsel, at the U.S. Senate HELP Committee, offered a Republican perspective of current proposals affecting device manufacturers and the FDA including efforts to expand liability coverage of PMA device manufacturers, revamp the 510(k) office and increased Congressional oversight.  Nick Shipley, Director, The McManus Group, and former Democratic staff for Jay Inslee (D-WA), offered the Democratic perspective and highlighted that Congressional scrutiny of the industry is likely to increase.

Many Annual Meeting attendees also took part in the Congressional Fly-In.  The Fly-In offered participants a chance to interact with their Members of Congress and their staffs to discuss some of the most pressing legislative issues affecting the innovative medical technology industry.

The first day concluded with a reception honoring Senator Orrin Hatch (R-UT).  Hatch, a senior member on the Senate Committee on Finance, was honored for his tireless efforts on behalf of small, medical technology companies.

The second day of the Annual Meeting began with an overview of several issues affecting device manufacturers commercializing overseas.  Vince H. Suneja, Director, Health Products and Technologies Team, Office of Health and Consumer Goods (OHCG) at the U.S. Department of Commerce, highlighted the work of the OHCG and what services and assistance they can provide to small medical technology companies.  Timothy Ulatowski, Director at the Office of Compliance CDRH, FDA, discussed the FDA’s efforts to reach out to the industry regarding the Global Harmonization Task Force.  The panel concluded with an insightful presentation by Ed Rozynski, VP Global Government Affairs at Stryker Corporation on the problems associated with foreign reference pricing and the impact upon US-based manufacturers.

With increased oversight from both Federal and State entities, the Key Compliance Issues in the Era of Oversight panel provided clarification upon several recently enacted and proposed initiatives affecting device manufacturers.  Eve Burns, a Partner at Ropes & Gray LLP discussed the recently enacted Massachusetts law restricting payments from device manufacturers to physicians and other healthcare providers.  Michael Sullivan, Partner at the Ashcroft Law Firm and Former US Attorney for the District of Massachusetts, discussed the recent trends of increased oversight of device company marketing practices by Federal agencies.  The panel concluded with a presentation by Mike Bell, President of R-Squared, who discussed managing payment disclosures in light of proposed Federal legislation requiring disclosure of such payments.

With healthcare reform on everyone’s mind, the Healthcare Reform in 2009 panel engaged a diverse intersections of opinions by former Congressional staffers.  Attendees heard competing perspectives on the impact of healthcare legislation on the device industry from the republican and democratic sides of the aisle; and also from representatives of the current and former administration.

The panel Comparative Effectiveness: Improving Quality or Rationing Care gauged the interest of many Annual Meeting attendees due to the potential impact comparative effectiveness may have on the industry.  The panel kicked off with Carolyn Clancy, MD, Director for Agency for Healthcare Research and Quality.  Clancy, whose agency will be leading comparative effectiveness research efforts, discussed the goals of AHRQ for comparative effectiveness and highlighted the impact it may or may not have on device manufactures.  Guy Clifton, MD, Runnells Distinguished Chair and Professor of Neurosurgery, University of Texas Health Science Center, Houston, offered his real-life perspective of why comparative effectiveness is necessary, but may be difficult to capture savings when applied to medical technology.  Finally, Gary A. Puckrein, PhD, President and Chief Executive Officer, National Minority Quality Forum, who discussed comparative effectiveness as it relates to addressing disparities in the healthcare system.

The Annual Meeting concluded with a presentation from Jonathan Blum, Director at Center for Medicare Management at CMS.  Blum discussed the Obama Administration’s goals for healthcare reform and more specifically what issues CMS is potentially looking to modify in the context of healthcare reform.

last updated 6.1.09

Agenda

Monday, June 1st

6:00 - 8:00pm

Opening Reception, Tivoli Room

Hosted by Crowell & Moring

Keynote Address

• Mark McClellan, MD, PhD, Director, Engelberg Center for Health Care Reform at the Brookings Institution and Leonard D. Schaeffer Chair in Health Policy Studies

Tuesday, June 2nd

8:00 - 8:40am

Registration, Hyde Park Foyer

8:40 - 10:00am

Welcome and Opening Breakfast, Hyde Park Room

• Mark B. Leahey, President and CEO
• Joe Kiani, Chairman and CEO, Masimo, MDMA Board Chairman

State of the Medical Device Industry, Hyde Park Room

• Industry expert, David Cassak, Windhover Information's Managing Partner, will discuss venture funding, acquisition activity and what lies ahead for the industry.

10:15 - 11:15am

Gaining Access to Capital in Challenging Times, Park Ballroom B&C

Discussion about how companies of various sizes can raise critical resources to survive and thrive in these uncertain times.

• Ryan Drant, General Partner, New Enterprise Associates
• J. Casey McGlynn, Chairman Life Sciences Group, Wilson Sonsini Goodrich and Rosati
• Lenka Fedorkova, PhD, Assistant Manager for the SBIR/ STTR Programs, National Institutes of Health

11:15 - 12:15pm

Improving the U.S. Patent System, Park Ballroom B&C

Participants will discuss administrative and legislative changes to the patent system that will create incentives to innovate and address application backlogs at USPTO.

• Steve Jensen, Partner, Knobbe Marten
• Andrew Hirshfeld, Acting Deputy Commissioner for Patent Examination Policy, U.S. Patent and Trademark Office
• Earl "Eb" Bright, General Counsel and VP, Intellectual Property, Exploramed

12:15 - 1:30pm

Luncheon Address: Medical Technology and Venture Capital: A Fruitful yet Fragile Ecosystem, Hyde Park Room

The session will highlight key issues identified in the MDMA/NVCA white paper exploring the relationship between venture capitalists and emerging medical technology companies. Specifically, speakers will discuss the critical innovations that have resulted from these interactions and the impact certain policies may have on the future of innovation.

• Jack W. Lasersohn, General Partner, The Vertical Group
• Robert Kieval, Executive VP and Chief Technology Officer, CVRx

1:30 - 2:15pm

CDRH Director's Update, Park Ballroom B&C

• Daniel G. Schultz, MD, Director, Center for Devices and Radiological Health, FDA, HHS

2:15 - 3:00pm

FDA: The Hill's Perspective, Park Ballroom B&C

Several legislative and administrative initiatives will be covered, including FDA Globalization Act, The Medical Device Safety Act and the UDI Initiative.

• Keith Flanagan, Minority Health Counsel, U.S. Senate HELP Committee
• Nick Shipley, Director, The McManus Group
• Moderator: John Manthei, Partner, Latham and Watkins

3:00 - 5:30pm

Congressional Fly-in, House and Senate Office Buildings

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

5:30 - 7:00pm

MDMA Chairman's Reception, Tivoli Room

Network with medical technology executives, government officials and other industry leaders while honoring Senator Orrin G. Hatch (R-UT) for his continued commitment to the medical technology industry.

Wednesday, June 3rd

7:30 - 8:15am

Networking Breakfast, Hyde Park Room

8:15 - 9:15am

International Opportunites and Challenges, Park Ballroom B&C

With more companies expanding overseas, panelists will discuss the areas with the greatest growth as well as discuss challenges in certain foreign markets.

• Vince H. Suneja, Director, Health Products and Technologies Team, Office of Health and Consumer Goods (OHCG), U.S. Department of Commerce
• Timothy Ulatowski, Director, Office of Compliance CDRH, FDA
• Ed Rozynski, VP Global Government Affairs, Stryker Corporation

9:15 - 10:15am

Key Compliance Issues in the Era of Oversight, Park Ballroom B&C

With increasing focus on the medical device industry, this panel will discuss the new Massachusetts regulations, pending federal legislation as well as recent enforcement actions. Panelists will also discuss key elements of a comprehensive compliance program.

• Eve M. Brunts, Partner, Ropes & Gray LLP
• Michael Sullivan, Partner, Ashcroft Law Firm, Former US Attorney for the District of Massachusetts
• Mike Bell, President, R-Squared

10:15 - 10:45am

Networking Break

10:45 - 11:30am

Healthcare Reform in 2009, Park Ballroom B&C

This interactive session will provide varying perspectives on key issues of the health care reform debate. Speakers will discuss the perspective of congressional democrats and republicans. as well as the Administration.

• Vincent J. Ventimiglia Jr., Senior Vice President, B & D Consulting
• John McManus, President, The McManus Group
• Sarah Walter, Walter Consulting
• Andrew M. Rosenberg, Senior Vice President, Ogilvy Government Relations

11:15 - 12:30pm

Comparative Effectiveness, Park Ballroom B&C

Improving Quality or Rationing Care-Panelists will debate the appropriate structure and use of comparative effectiveness research.

• Carolyn Clancy, MD, Director, Agency for Healthcare Research and Quality
• Guy Clifton, MD, Runnells Distinguished Chair and Professor of Neurosurgery, University of Texas Health Science Center, Houston
• Gary A. Puckrein, PhD, President and Chief Executive Officer, National Minority Quality Forum
• Moderator: Beth Roberts, Partner, Hogan & Hartson

12:30 - 1:45pm

Luncheon Keynote: CMS Update, Hyde Park Room

• Jonathan Blum, Director, Center for Medicare Management, CMS

1:45pm

Closing Remarks, Hyde Park Room

• Mark B. Leahey, President & CEO, MDMA