Tuesday, September 23
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TIME |
TRACK |
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9:00-10:30 a.m. |
21st Century Health Policy |
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Panel: |
Can Innovation Thrive in a Healthcare System focused on both Clinical and Cost Effectiveness? |
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9:00-10:30 a.m. |
Business Development |
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Panel: |
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9:00-10:30 a.m. |
Compliance Best Practices |
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Panel: |
Use of Distributors in the Promotional Process - Managing the Risks |
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9:00-10:30 a.m. |
Legal / IP |
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Panel: |
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9:00-10:30 a.m. |
Reimbursement |
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Panel: |
Clinical Utility or Impossibility? Meeting Evolving Value Requirements for Devices and Diagnostics |
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10:30-10:45 a.m. |
Refreshment Break (Exhibit Hall) |
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10:45 a.m.-12:15 p.m. |
21st Century Health Policy |
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Panel: |
Balancing on the Edge: Managing the Dynamics of Risk, Innovation, and Globalization |
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10:45 a.m.-12:15 p.m. |
Business Development |
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Panel: |
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10:45 a.m.-12:15 p.m. |
Compliance Best Practices |
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Panel: |
Success Strategies for Assuring Compliance Across a Combination Product's Lifecycle |
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10:45 a.m.-12:15 p.m. |
Legal / IP |
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Panel: |
Recent Developments in Intellectual Property Law for MedTech Companies |
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10:45 a.m.-12:15 p.m. |
Reimbursement |
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Panel: |
Novelties of Health-Economic Evidence Requests for Medical Devices in EU |
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2:00-3:30 p.m. |
21st Century Health Policy |
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Panel: |
Health Care Reform 2009-2010: Experts' Views of the Road Ahead |
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2:00-3:30 p.m. |
Business Development |
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Panel: |
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2:00-3:30 p.m. |
Global Business Issues |
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Panel: |
Expansion into Asia-Pacific: Challenges & Opportunities for MedTech Companies |
2:00-3:30 p.m. |
Medical Technology Product Innovation |
Panel: |
Wired & Unwired: MedTech's Convergece with the IT & Wireless Sectors |
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2:00-3:30 p.m. |
Quality Management |
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Panel: |
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2:00-3:30 p.m. |
Reimbursement |
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Panel: |
A Strategic Overview of CMS Reimbursement for Medical Devices |
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3:30-4:00 p.m. |
Refreshment Break (Exhibit Hall) |
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4:00-5:30 p.m. |
21st Century Health Policy |
|
Panel: |
The Longevity Boom: Opportunities for Medical Technology Innovation |
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4:00-5:30 p.m. |
Business Development |
|
Panel: |
Traditional and Alternative Methods of Financing Your Medical Device Company |
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4:00-5:30 p.m. |
Global Business Issues |
|
Panel: |
A New Paradigm: Development of Partnerships with Private Healthplans |
4:00-5:30 p.m. |
Medical Technology Product Innovation |
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Panel: |
Remote Patient Monitoring Technologies: Opportunities and Issues |
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4:00-5:30 p.m. |
Quality Management |
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Panel: |
|
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4:00-5:30 p.m. |
Reimbursement |
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Panel: |
Can Innovation Thrive in a Healthcare System Focused on Both Clinical and Cost Effectiveness?
Track: 21st Century Health Policy
Tuesday, September 23, 9:00-10:30 a.m.
Room Location: Washington 2
A vital aspect of government's role in shaping health policy is to foster innovation by encouraging uptake of new products and technologies. However, as economic pressures force the US to move towards a value-based healthcare system, and costs and margins get squeezed, will innovation be a key casualty? In the UK, where uptake within the NHS is driven by both price and performance, what lessons can be learned from companies that have been successful in this market? The panel will examine these issues, drawing on the experiences of the UK's National Institute for Health & Clinical Excellence (NICE) and the private sector in a value-based healthcare system.
Moderator: Jeremy Nobel, M.D., MPH, Adjunct Lecturer on Health Policy and Management, Harvard School of Public Health
Moderator: Jeremy Nobel, M.D., MPH, Adjunct Lecturer on Health Policy and Management, Harvard School of Public Health
Speakers:
Andrew Dillon, Chief Executive, National Institute for Health & Clinical Excellence (NICE)
Sir Duncan Nichol, Former Chief Executive of the NHS and Non-Executive Director, Deltex Medical
Parashar Patel, Vice President, Health Economics & Reimbursement, Boston Scientific Corporation
Sean Tunis, M.D., MSc, Director, Center for Medical Technology Policy
Diagnostics Financing Trends
Track: Business Development / Finance
Tuesday, September 23, 9:00-10:30 a.m.
Room Location: Washington 5
Investing in early stage molecular diagnostics companies has historically lagged far behind investments in companies developing therapeutics or medical devices. This panel will consider whether there is evidence of growth in diagnostics deal flow with regard to traditional venture capital, corporate venture capital, and angel investing. Panelist will offer entrepreneurs suggestions on improving the funding prospects for their emerging diagnostics companies.
Moderator: Vijay Lathi, Managing Director, New Leaf Venture Partners
Panelists:
Andrew Jay, Managing Partner, Medical Solutions Fund, Siemens Venture Capital, Inc.
Richard Crawford, Managing Director, Virginia Active Angel Network
Vijay Aggarwal, CEO, Aureon Laboratories
Eric Aguiar, M.D., Partner, Thomas, McNerney & Partners
V. Randy White, Ph.D., CEO, Adnavance Technologies, Inc.
Use of Distributors in the Promotional Process - Managing the Risks
Track: Compliance Best Practices
Tuesday, September 23, 9:00-10:30 a.m.
Room Location: Hoover
With the increased focus of the enforcement community on promotional activities of medical device, diagnostics, and technology companies and the precedent set for substantial penalties due to alleged non-compliance with laws and standards, there is a heightened sense of awareness amongst company stakeholders that management of the risks is a priority. But managing risks should not just be limited to the activities of company employees. Since use of distributors for promotion of company products is common in the industry, effective risk management controls must include activities of distributor employees as well. During this session, our panelist will discuss the unique challenges to managing risks related to distributor activities in the U.S. and international markets, and share insight on best practices for managing these risks.
Moderator: Eileen Erdos, Principal, Fraud & Investigative Dispute Services, Ernst & Young
– Back To Top –
Proving Medical Necessity: From Claims to Appeals
Track: Legal / IP
Tuesday, September 23, 9:00-10:30 a.m.
Room Location: Coolidge
Having completed the long process of obtaining government approvals for new technology, the manufacturer may enter the marketplace only to find yet another hurdle. Even covered products and devices will not be reimbursed by third party payors or Medicare unless they are considered "medically necessary." This panel will address the issues related to establishing medical necessity for new technologies. Because Medicare is the predominant payor and often the toughest taskmaster on this issue, the panel would focus on the Medicare Medical Review process. Our panel will feature Ms. Susan Morris of KCI, who will address her participation with the Medical Directors of the Regional Carriers in developing a local coverage determination (LCD) for the Wound VAC©. The panel will address the following additional topics:
- The impact of Carrier Policy Articles, bulletins and other formal and informal guidelines on medical necessity
- The process of challenging medical necessity determinations by the Medicare program
- How best to make the case for medical necessity, including the evidence most likely to be influential before payors and adjudicators
- The fraud and abuse and liability implications of corporate representations about medical necessity
Moderator: Donna K. Thiel, Shareholder, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
Panelists:
Terence Liley, Senior Attorney, Office of Medicare Hearings and Appeals
Susan P. Morris, Vice President Health Policy, Kinetic Concepts Inc.
Richard Toselli, M.D., Vice President, Evidence-Based Medicine, Office of Science and Technology, Johnson & Johnson
Clinical Utility or Impossibility? Meeting Evolving Value Requirements for Devices and Diagnostics
Track: Reimbursement
Tuesday, September 23, 9:00-10:30 a.m.
Room Location: Washington 4
As health decision makers request more complex and costly evidence of product value, manufacturers are pressed to generate an expanding variety of evidence to support product reimbursement, adoption and diffusion. Preferences for historical evidence hierarchy-based approaches, where the randomized controlled trial (RCT) is considered ideal, have complicated evolution of HTA practices that take into account the unique factors inherent to devices and diagnostics. For such rapidly evolving technologies, it is clear that one-size-fits-all approaches challenge innovation and access. As the “rules of the road” continue to change for devices and diagnostics, how do manufacturers maximize commercialization potential, minimize avoidable risks, and distinguish “got to have” versus “nice to know” evidence requirements? This panel will explore current practice and policy issues in an environment increasingly focused on value-based and personalized health care, where stakeholders often seek direct evidence of clinical utility to characterize product value. How can we meet evolving evidence requirements for devices and diagnostics in a manner that balances our need for evidence with the practical realities required for obtaining such information? How should the requirements for value-based decision-making for devices develop and are evolving requirements reasonable?
Moderator: Eric C. Faulkner, MPH, Senior Director, US Market Access and Reimbursement, RTI Health Solutions and Director, Genomics Biotech Institute, National Association of Managed Care Physicians
Panelists:
Randel E. Richner, BSN, MPH, President, NeoCure Group
Marcel Salive, MD, MPH, Director, Division of Medical and Surgical Services, Coverage and Analysis Group, Centers for Medicare and Medicaid Services
Patrick Terry, Co-Founder, Genomic Health
Richard Toselli, M.D., Vice President, Evidence-Based Medicine, Office of Science & Technology, Johnson & Johnson
Balancing on the Edge: Managing the Dynamics of Risk, Innovation, and Globalization
Track: 21st Century Health Policy
Tuesday, September 23, 10:45 a.m.-12:15 p.m.
Room Location: Washington 2
Similar to the advent of the World Wide Web, medical technology continues to evolve with changing strategies, business models, and products. This international CEO panel will explore some of the key factors of the evolution of the industry, particularly as they relate to product innovation and market entry. Among the key issues that will be discussed are emerging product development and commercial models, international regulatory compliance, and the importance of integrating risk intelligence in every business decision. Panelists will share insights regarding the elements necessary to support innovation in a global marketplace, including critical considerations as they manage risk, protect intellectual property, and harness the power of globalization from a product development, sourcing, and sales standpoint.
Moderator: Eric C. Faulkner, MPH, Senior Director, US Market Access and Reimbursement, RTI Health Solutions and Director, Genomics Biotech Institute, National Association of Managed Care Physicians
Panelists:
Randel E. Richner, BSN, MPH, President, NeoCure Group
Marcel Salive, MD, MPH, Director, Division of Medical and Surgical Services, Coverage and Analysis Group, Centers for Medicare and Medicaid Services
David Browning, Ph.D., CEO, Personalized Healthcare, Philips Healthcare
Christina Farup M.D., MS, Vice President, Evidence-Based Medicine, DePuy, Inc. (a Johnson & Johnson company)
Balancing on the Edge: Managing the Dynamics of Risk, Innovation, and Globalization
Track: 21st Century Health Policy
Tuesday, September 23, 10:45 a.m.-12:15 p.m.
Room Location: Washington 2
Similar to the advent of the World Wide Web, medical technology continues to evolve with changing strategies, business models, and products. This international CEO panel will explore some of the key factors of the evolution of the industry, particularly as they relate to product innovation and market entry. Among the key issues that will be discussed are emerging product development and commercial models, international regulatory compliance, and the importance of integrating risk intelligence in every business decision. Panelists will share insights regarding the elements necessary to support innovation in a global marketplace, including critical considerations as they manage risk, protect intellectual property, and harness the power of globalization from a product development, sourcing, and sales standpoint.
Moderator: R. Terry Hisey, Vice Chairman & U.S. Life Sciences Leader, Deloitte LLP
Panelists:
José (Joe) Almeida, President, Medical Devices, Covidien
David B. Perez, President and CEO, CaridianBCT, Inc.
Richard Toselli, M.D., Vice President, Evidence-Based Medicine, Office of Science and Technology, Johnson & Johnson
Dual Track Exits: Keeping Your Liquidity Options Open
Track: Business Development / Finance
Tuesday, September 23, 10:45 a.m.-12:15 p.m.
Room Location: Washington 5
Privately-held medical technology companies often choose to achieve liquidity for their investors through mergers with bigger players. This well worn path can be the best way to maximize shareholder value, especially when evaluated against the risk/reward of going it alone. As development runways lengthen, however, companies need to consider whether shareholder value will be enhanced by turning to public capital markets to fund further development. A healthy IPO market provides alternatives, both for companies and their investors, to stay independent longer to avoid becoming "captive" to a potential acquirer. Having a liquid stock also provides access to continued funding in the form of follow-on offerings. This panel will explore the strategic and operational aspects considered by companies that have successfully moved down both tracks. This would include issues such as the types of companies that may be best suited to pursue a dual track strategy, what companies need to consider in order to build commercially sustainable organizations, as well as tactical issues such as the decision process surrounding, including the prioritization of, incremental investments in infrastructure (personnel, policies and procedures, etc.) necessary to operate as a public company.
Moderator: John Babitt, Senior Manager, Transaction Advisory Services, Ernst & Young
Panelists:
Robert DeSutter, Co-Head of Healthcare Equity Investment Banking, Piper Jaffrey
Gregory Belinfante, Managing Director, One Equity Partners
Zev Scherl, General Partner, NewSpring Capital
Dan Gladney, Operating Partner, Norwest Equity Partners
Success Strategies for Ensuring Compliance Across a Combination Product’s Lifecycle
Track: Compliance Best Practices
Tuesday, September 23, 10:45 a.m.-12:15 p.m.
Room Location: Hoover
Commercialization of combination products poses a unique set of challenges. Our moderated panelists will discuss their insights, experiences and best practices to ensure compliance. The discussion will touch on clinical evaluation, manufacture, regulatory requirements, and safety surveillance of combination products.
Moderator: Brian A. Burk, Senior Vice President, Sales & Marketing Compliance, Kaplan EduNeering
Panelists:
Gary Thompson, Vice President, Clinical Operations, Abbott Vascular
Chris Kane, U.S. Sales Training Leader, W L Gore & Associates
Paul Chaney, President, OSI Eyetech
Russ Davies, Vice President, Global Regulatory Affairs, Smiths Medical
The Changing IP Landscape in the U.S. and Europe: What It Means for You
Track: Legal / IP
Tuesday, September 23, 10:45 a.m.-12:15 p.m.
Room Location: Coolidge
Now, more than ever before, the vitality of a medical device company turns on the strength of its intellectual property ("IP") position. Recent and anticipated changes in U.S. and European patent law will have a significant effect on such companies' ability to protect and enforce their IP. This panel will discuss the implications of several recent decisions of the U.S. Supreme Court and the Court of Appeals for the Federal Circuit, and other recent and proposed developments in U.S. and European and Community patent law. Learn how the "EPC 2000" and the London Protocol on European patent translations, are expected to have a lasting effect on medical device companies doing business around the world.
Moderator: Brian Hopkins, Esq., Member, Medical Device Practice Group, Mintz Levin
Panelists:
William “Bill” Murray, Division Counsel, Abbott Laboratories
Julian Crump, Head, Chemistry and Life Sciences Group, Mintz Levin
John R. Thomas, Professor of Law, Georgetown University
David Schramm, Senior IP Litigation Attorney, Corporate Innovations, Medrad, Inc.
Novelties of Health-Economic Evidence Requests for Medical Devices in EU
Track: Reimbursement
Tuesday, September 23, 10:45 a.m.-12:15 p.m.
Room Location: Washington 4
Regulatory requirements for clinical trials are now increasing. This implies tightened standards in the EU for CE marking upon MDD amendments. In addition to this CE marking process cost-effectiveness analysis is used for assessments of medical devices performed by National Health Care Decision Boards in Germany, France, and UK, the so-called "Big Three" in Europe. It is an increasing requirement for policy makers as well as for stakeholders to acquire real-time knowledge about developments in various health care systems and to critically assess their success or failure in practice. Institutes with high influence on coverage and pricing of Medical Devices are IQWiG or G-BA in Germany, NICE or PASA-CEPS in UK, and CEPP (HAS) or CEPS in France. The presentation will provide an overview of health-economic assessment tools used by these forefront decision bodies. Illustrations will exemplify assessments carried out.
Moderator: Hubertus Rosery, President & CEO, AiM GmbH
Panelists:
Hubertus Rosery, President & CEO, AiM GmbH
Jacques Biot, CEO and Founder, JNB-Développement S.A.
Richard Devereaux-Philips, Public Affairs Manager, Medtronic Limited
– Back To Top –
Health Care Reform 2009-2010: Experts' Views of the Road Ahead
Track: 21st Century Health Policy
Tuesday, September 23, 2:00-3:30 p.m.
Room Location: Washington 2
Americans are once again identifying access to health care as one of the nation's most pressing problems, a fact reflected in this year's presidential campaign. While national health care reform could present many opportunities for medical technology companies, it also would present many challenges. In this session, a panel of experts spanning the ideological spectrum will engage in a robust debate about the shape that national health care reform should take and the political feasibility of their proposals. Panel members will share their differing views on reform plans ranging from a single-payor, government-administered approach to a market-based approach, and the multiple variations in between these two models. In addition, panelists will address specific elements of health care reform that could have a significant impact on the medical technology industry, including initiatives related to comparative effectiveness research and price transparency, as well as the creation of new national benefit mandates and/or the elimination of current state benefit mandates. Finally, the panelists will assess the likelihood of serious congressional action on health care reform in 2009-2010 and whether their proposals can withstand the scrutiny and political heat associated with nationalized debates on Capitol Hill.
Moderator: Paul Seltman, Counsel, Drinker Biddle & Reath
Panelists:
Jack Meyer, Principal, Health Management Associates, former Founder and President of the Economic and Social Research Institute
Michael Tanner, Senior Fellow, Cato Institute
Diane Archer, Special Counsel and Co-Director of the Health Care for All Project, Campaign for America’s Future
Partnerships with Clinicians: Is Collaboration Dead?
Track: Business Development / Finance
Tuesday, September 23, 2:00-3:30 p.m.
Room Location: Washington 5
What will the future of medical device development look like with heightened public scrutiny and skepticism regarding the interactions between physician and manufacturers? Are doctors being scared away to the detriment of innovation? Potentially AdvaMed could execute a poll of clinicians to determine how they would respond to medical device companies publishing all clinician relationships for the public's consumption. Would clinicians continue to collaborate with industry? Would this impact innovation and patient care? Hear a distinguished panel of experts discuss these unanswered questions and more.
Moderator: Paul G. Yock, M.D., Department of Bioengineering and Program in Biodesign, Stanford University Medical Center
Panelists:
David C. Dvorak, President and CEO, Zimmer
Jack Lewin, M.D., CEO, American College of Cardiology
Ziyad Hijazi, MD, MPH, FSCAI, FACC, FAAP, Director, Rush Center for Congenital & Structural Heart Disease, and President, SCAI
John Parrish, M.D., Executive Director and Founder, Center for Integration of Medicine and Innovative Technology (CIMIT), Massachusetts General Hospital, Harvard Medical School
Expansion into Asia-Pacific: Challenges & Opportunities for MedTech Companies
Track: Global Business Issues
Tuesday, September 23, 2:00-3:30 p.m.
Room Location: Wilson BC
In autumn 2008, Ernst & Young expects to publish a comprehensive study that will assist medical technology companies in planning the expansion of their distribution, manufacturing, and /or research & development facilities within the Asia-Pacific market. As we see today, only the larger medtech players have had the capacity to establish operations in these functions. Conversely, most of the small-to-midsize medtechs are distributing their products through local organizations and likely have limited local capabilities. The small-to-midsized medtech players will need to increase their capabilities within these functions if they wish to compete within the fast-growing Asia-Pacific market. However, these companies must also realize the risks of building their own manufacturing, distribution, and R&D capabilities in Asia-Pacific are significant and not easy to manage. The aforementioned study will be the result of an extensive research project, as well as first-hand interviews between Ernst & Young and company executives from 20 medical technology companies that are headquartered with Europe and North America. This panel will discuss the following topics from the perspectives of the panel members:
- Demonstrate the pros and cons of different locations (India, Singapore, China, Japan)
- Outline the risks and challenges of expansion into Asia-Pacific
- Share best practices from their companies' recent experiences in the marketplace
Moderator: Heinrich Christen, Partner, European Medical Devices Leader, Ernst & Young
Panelists:
Corinne Lyle, President, Global Operations, Edwards Lifesciences
Chris Miller, Senior Director, Healthcare Economics and Reimbursement, Medtronic Asia Pacific
Wired & Unwired: MedTech’s Convergence with the IT & Wireless Sectors
Track: Medical Technology Product Innovation
Tuesday, September 23, 2:00-3:30 p.m.
Room Location: Coolidge
We live in a connected world and no technology can stand on its own. Increasingly, medical device makers must take into account wireless applications, interfacing with the internet, software, supply chain systems, post market tracking and surveillance - and more. Integration of the patient and government perspectives is critical as well. How are regulatory agencies looking at compliance now? What do patients expect from their doctors? We'll discuss integration of these technologies, where the market is going in this area, interoperability and where our communities can collaborate. Hear from our panel of experts on how wireless equipment and software applications are being used to advance medical devices and bring better patient care.
Moderator: Karen Katz, Director, Health Care & MedTech, Mintz Levin
Panelists:
Charlie Huiner, Vice President, Business Development, InTouch Health
George Hill, Vice President, Investment Banking, Leerink Swann
Clint McClellan, Senior Director, Market Development, QUALCOMM Health and Life Sciences
Joe Miles, Senior Director, Life Sciences Industry Solution Group, SAP America, Inc.
Slim Down with Lean Quality
Track: Quality Management
Tuesday, September 23, 2:00-3:30 p.m.
Room Location: Hoover
During these turbulent economic times, everybody is talking about slimming down and becoming lean. Companies that are implementing lean manufacturing programs to improve performance and reduce costs may be incapable without predictable processes built through effective quality management, thereby preventing many lean goals from being met. Cutting corners with your quality systems and processes is not the answer. With so many process efficiency models today, how can you get to “Lean Quality?” Come listen to this Panel discussion on how some key medical device companies have achieved Lean Quality.
Moderator: Nikki Willett, Vice President, Marketing & Regulatory Affairs, Pilgrim Software, Inc.
Panelists:
Bob Dicheck, Vice President, Quality & Regulatory, Osmetech
Linda Lovett, Principle Consultant, Lovett Consulting, LLC
Bob Sendek, IT Manager Manufacturing Quality Systems, Physio-Control, Inc.
A Strategic Overview of CMS Reimbursement for Medical Devices
Track: Reimbursement
Tuesday, September 23, 2:00-3:30 p.m.
Room Location: Washington 4
This session is designed to analyze and review CMS Reimbursement policies and issues from the perspective of the manufacturer. CMS coverage and reimbursement decisions are critical to the success of medical device companies and their product lines. This session will review how CMS currently evaluates medical devices and technology. It will also discuss future challenges that new products may face in the upcoming years. It will conclude with observations of how the management of medical device companies should approach the development of technologies from a reimbursement perspective.
Moderator: John Dwyer, Arent Fox LLP
Panelists:
Tom Gustafson, Senior Health Policy Advisor, Arnold & Porter LLP; formerly Acting Director, Center for Medicare Management, CMMS
Parashar Patel, Vice President of Health Economics and Reimbursement, Boston Scientific
Kathy Means, Consultant; formerly on staff of Senate Finance Committee, Ways & Means Committee, and CMS
Jamie Ravitz, Partner Arent Fox LLP
The Longevity Boom: Opportunities for Medical Technology Innovation
Track: 21st Century Health Policy
Tuesday, September 23, 4:00-5:30 p.m.
Room Location: Washington 2
Our population is enjoying a longevity boom that has vastly changed the world’s demographic landscape. As people live longer and pursue more active lifestyles, there is a mounting demand from baby boomers for innovative medical care that will not only extend their lives, but preserve their health and quality of life. The medical device industry is uniquely positioned to play a pivotal role in tackling many of the inevitable issues associated with the aging body. This session will focus on the shifting demographics, economic impact, and consumer behavior of the aging population, and highlight the growth opportunities for innovation created by these changes. Panelists will include recognized authorities in the areas of demographics, health care economics, and consumer behavior. The presenters will explore how continued medical research and innovation can help patients around the world face the unique challenges and opportunities presented by the “Age Wave.”
Moderator: Paul H. Keckley, Ph.D., Executive Director, Deloitte Center for Health Solutions
Panelists:
Linda George, Ph.D., Professor of Sociology and Associate Director, Center for the Study of Aging and Human Development, Duke University
Ashoke Bhattacharjya, Ph.D., Executive Director, Health Policy and Economics, Asia-Pacific, Johnson & Johnson
John DeFord, Ph.D., Senior Vice President of Clinical and Scientific Affairs, C.R. Bard
Luciano Cattani, Executive Vice President, International Public Affairs, Stryker Corporation
Traditional and Alternative Methods of Financing Your Medical Device Company
Track: Business Development / Finance
Tuesday, September 23, 4:00-5:30 p.m.
Room Location: Washington 5
Seasoned entrepreneurs, bankers, angels, venture capitalists and government grant experts weigh in on how best to finance your medical device or diagnostics company. Learn from those who have seen companies grow and fail to grow from every angle possible. Hear commentary on the value of venture funding vs. the autonomy of going it alone or with help from the government or other sources. What legal structures can you put in place to help your company grow? How can you best to position your company for either acquisition or exit via IPO? Come and hear shared insights regarding the current market for medtech financing and what you should do.
Moderator: William Whelan, Esq., Co-Chair Life Sciences Practice, Mintz Levin
Panelists:
Andrew Jay, Managing Partner, Siemens Venture Capital, Inc., Medical Solutions Fund
John L. Brooks, III, President and Managing Director, Medical Capital Group
Jason Koshnitsky, President & CEO, Orbital Therapy
Dave D. Hood MS, MBA, PMP, Senior Advisor for the Principle Assistant for Acquisitions, US Army MRMC/TATRC/CDMRP
A New Paradigm: Development of Partnerships with Private Health Plans
Track: Global Business Issues
Tuesday, September 23, 4:00-5:30 p.m.
Room Location: Wilson BC
This unique panel discussion, which will include employer, provider, manufacturer and health plan representation, will explore how manufacturers and health plans can help each other meet their business goals. From joint outcome studies to demand matching and infection control initiatives to comparative effectiveness assessments and economic value studies, there are myriad opportunities for these two stakeholders to work together and embrace their common goals. Even direct manufacturer/health plan purchasing partnerships will be explored. While the current paradigm often leaves manufacturers guessing as to what exactly health plans need to support a new technology, (especially technologies that promote a personalized medicine model), this new paradigm takes some of the guess work out of the process while simultaneously allowing both partners to pursue their individual business models. To do this, they must understand and explore how employers have begun to work with health plans to contain medical costs, and simultaneously promote quality of care. Initiatives such as value-based benefit designs, tiered provider networks, and pay-for-performance initiatives will be discussed. In addition, manufacturers should thoroughly understand the mechanics underlying the provider network management, case management, and actuarial models used by health plans. Once these business models are understood, manufacturers can identify areas that they may be able to influence in ways that benefits both parties. While these partnerships will not guarantee positive coverage and reimbursement decisions, they offer unique opportunities for value-driven technologies to be recognized in a more expeditious and efficient fashion. Precedents for this model will also be discussed.
Moderator: David A. Gregory, Executive Vice President, Presscott Associates, Ltd.
Panelists:
Eric Rugo, Director of Reimbursement Services, Stryker Orthopaedics
Ed Lucy, Senior Vice President - Delivery System Management and Strategy, HIP Health Plan of Greater New York
Jeff Bush, Director, Corporate Reimbursement, BD
Alan B. Rosenberg, M.D., Vice President of Medical Policy, Technology Assessment & Credentialing Programs, WellPoint, Inc.
Remote Patient Monitoring Technologies: Opportunities and Issues
Track: Medical Technology Product Innovation
Tuesday, September 23, 4:00-5:30 p.m.
Room Location: Coolidge
Remote patient monitoring technologies have been used to help physicians monitor cardiology, diabetes and asthma patients for close to a decade. In-home technology is vital for measuring patient progress during the intervals between physician office visits, in circumstances where the availability or proximity between patient and physician is difficult or impractical and in involving the patient in the management of their condition. The Deloitte Center for Health Solutions estimates that $400 billion dollars per year could be saved in U.S. health care costs in reduced emergency room visits, hospitalizations, unscheduled physician office visits and by improving patient self–management of their disease if these technologies were more widely implemented. The technology needed to monitor chronic diseases is well proven and well tested, yet it has been underutilized and poorly adopted due to issues that include reimbursement, physician education, ease of use of the technology and other adoption barriers. This panel will discuss patient-centric technologies that have been developed to remotely monitor chronic illnesses, and review issues preventing broad implementation of the technology. The panel will explore the applications of the technology, potential benefits to the parties involved (patients, physicians and healthcare providers), and issues delaying adoption of the technology. Panelists will have an interactive discussion with the audience to discuss how obstacles to implementation (education of healthcare providers, reimbursement mechanisms by CMS and other third party payors, etc) could be overcome to realize the very real benefits of remote patient monitoring technologies.
Moderator: Jack Bush, President & Chief Executive Officer, Imed Health Technologies
Panelists:
Cynthia Pacheco, General Manager, Phillips Telehealth Solutions
Paul H. Keckley, Ph.D., Executive Director, Deloitte Center for Health Solutions
Larry Leisure, President and Chief Revenue Officer, iMetrikus
Joseph C. Kvedar, M.D., Director, Center for Connected Health
Getting More Value from Your Medical Devices After the Sale
Track: Quality Management
Tuesday, September 23, 4:00-5:30 p.m.
Room Location: Hoover
Advances in data transfer and online collaboration have created the potential for connected technologies or collaborative exchanges between technicians and physicians to drive product improvements. Automakers are using real-time diagnostic data to improve warranty claim rates and product quality. Imagine the benefits of a medical device information exchange:
- Proactive Monitoring and Preventive Maintenance – Predict and service equipment before it fails.
- Product Quality Improvements – Better root-cause analysis and issue remediation.
- Collaboration for Best Use – Improve workflow with “smart” devices.
- Utilization and Benchmarking – Analyze equipment up-time and profitability.
- Demonstrated Value of Device-Enabled Therapies – Improve quality of care.
Ellen Reilly, BearingPoint (chair), Chris La Fratta, Philips Healthcare and Dan Pettus, Cardinal Health, plus an automotive industry representative, will discuss smart technology to drive hospital productivity and revenue, improve product quality and demonstrate added value to health care.
Moderator: Ellen Reilly, Managing Director, BearingPoint
Panelists:
Chris La Fratta, Director, Global Services Engineering Programs, Philips Healthcare
Dan Pettus, Vice President, Cardinal Health
James Sobel, Director, Product Management, Questra Corporation
Technology Assessment of Diagnostic and Monitoring Tests
Track: Reimbursement
Tuesday, September 23, 4:00-5:30 p.m.
Room Location: Washington 4
When considering coverage for diagnostic and monitoring tests, Medicare and other payers consider the evidence on whether the test improves patient outcomes. Most of the studies that are published in the peer reviewed literature on diagnostic and monitoring tests measure technical performance and sensitivity and specificity of the tests, but do not report patient outcomes. In this session, we will describe several case studies of technology assessments on diagnostic and monitoring tests commissioned from the Agency for Healthcare Research and Quality by the Medicare Coverage and Analysis Group on such diverse topics as pharmacogenetic testing, remote cardiac monitoring and home monitoring for sleep apnea, and discuss the common framework that is used to evaluate these and other tests. We will describe one case study in particular: esophageal Doppler monitoring for cardiac output. Deltex Medical Group, manufacturer of the CardioQ device for monitoring cardiac output using an esophageal Doppler probe, received clearance for marketing their device in the United States by the Food and Drug Administration (FDA) on August 6, 2003 via the 510(k) premarket notification process. Use of the device to measure cardiac output was listed as a non-covered indication under the Medicare program when the agency accepted a formal request from the manufacturer requesting reconsideration of the non-coverage decision on August 31, 2006. Data from studies in the peer review literature suggested that the use of the device leads to a reduction in complications and days in the hospital. This data was a strong consideration in the agency's decision to cover the technology for cardiac monitoring, effective May 22, 2007. A greater understanding of the framework for evaluation of diagnostic and monitoring tests will help industry design studies that will provide better evidence for decision making by payers, physicians and patients.
Moderator: Elise Berliner, Ph.D., Director, Technology Assessment Program, Agency for Healthcare Research and Quality
Panelists:
Louis Jacques, M.D., Director, Division of Items and Devices, Coverage & Analysis Group, OCSQ
Karen Schoelles, M.D., S.M., Director, Evidence-Based Practice Center, ECRI Institute
Andy Hill, Chief Executive, Deltex Medical