Wednesday, September 24
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TIME |
TRACK |
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9:00-10:30 a.m. |
Business Development |
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Panel: |
Looking Out Ahead: Critical Issues to Consider when Entering an M&A Transaction |
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9:00-10:30 a.m. |
Global Business Issues |
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Panel: |
Medical Device Companies Competing on Cost-Optional Today, Required Tomorrow |
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9:00-10:30 a.m. |
Medical Technology Product Innovation |
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Panel: |
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9:00-10:30 a.m. |
Product Quality & Manufacturing Innovation |
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Panel: |
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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. |
Business Development |
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Panel: |
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10:45 a.m.-12:15 p.m. |
Global Business Issues |
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Panel: |
China’s Healthcare Reform: Solving Problems or Creating New MedTech Woes? |
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10:45 a.m.-12:15 p.m. |
Medical Technology Product Innovation |
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Panel: |
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10:45 a.m.-12:15 p.m. |
Product Quality & Manufacturing Innovation |
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Panel: |
Contract Manufacturing: Managing Supplier and Outsourcing Partnerships |
Looking Out Ahead: Critical Issues to Consider when Entering an M&A Transaction
Track: Business Development / Finance
Wednesday, September 24, 9:00-10:30 a.m.
Room Location: Washington 5
The purpose of this panel is to analyze business considerations driving the decision to acquire a medical device business or technology (including an analysis of the business landscape). The panel will analyze business, legal and IP issues that must be addressed in connection with performing due diligence with respect to an acquisition as well as strategies for negotiating such acquisitions and bring an actual deal team that has worked together on these transactions.
Moderator: James Staiger, Esq., Partner, Blank Rome LLP
Panelists:
Robert Hallenbeck, Vice President, Business Development & Strategic Investments, BD
Scott Miller, Vice President, Corporate Development, Covidien
Chad Cornell, Director, Business Development, Medtronic, Inc.
Judy Meritz, Esq., Partner, Blank Rome LLP
Medical Device Companies Competing on Cost-Optional Today, Required Tomorrow
Track: Global Business Issues
Wednesday, September 24, 9:00-10:30 a.m.
Room Location: Wilson BC
AdvaMed has identified five long-term trends the medical device industry will be facing over the next five years – and it’s no surprise that four of the five are related to rising costs:
- Medicare becoming an aggressive purchaser of medical devices
- News media giving more focus to the cost, safety, and ethics of all healthcare players
- FDA adding regulations to reduce risk
- Cost becoming the only source of competitive advantage in emerging markets like China
- Increasing pressure to contain healthcare costs as a percent of the Federal budget
These trends make one thing very clear: U.S. medical device companies are at risk of losing new opportunities globally because their supply chain and sourcing practices cannot compete on cost. The panel will present current best practices and what we believe will be required best practices in the next five years. This will be followed by an examination of how medical device companies in other countries are organizing and leveraging their supply chains and supply bases to globally compete better on cost. Panelists will include AdvaMed member companies that will share how they are moving to flexible supply chains with supply bases localized in lower-cost countries. The panel will conclude with a road map for transforming the supply chain based on our prior successful experiences with global companies.
Moderator: David Busch, Principal, PRTM
Panelists:
Kevin Castle, Chief Procurement Officer, Varian
Paul Freestone, Vice President, Manufacturing Sourcing, Stryker
Tim Durst, Director, PRTM
The Need and Use of Pre-Clinical Product Testing
Track: Medical Technology Product Innovation
Wednesday, September 24, 9:00-10:30 a.m.
Room Location: Washington 1
Improving pre-clinical product testing can lead to new innovations, improved regulatory processes, and is directly linked to better product performance in the market. The use of animal models that mimic human disease is the key to these improvements. The ability to have practicing clinicians perform this testing, and then working with them through the clinical testing phase and on into the market creates a continuity of research experience that saves time, reduces the stress of regulatory process issues and provides a reliable reference in the academic literature for confidence in the market.
Moderator: Mr. Terry J. Fadem, Managing Director, Corporate Alliances, University Of Pennsylvania School of Medicine
Panelists:
Barbara Ann Huibregtse, DVM, Director Preclinical Sciences, Boston Scientific Corporation
Joseph Hevey Gorman III, Associate Professor of Surgery, University Of Pennsylvania - Gorman Cardiovascular Research Group
Robert Louis Wilensky III, Professor of Medicine, Hospital of the University of Pennsylvania
Winning Profit in the Age of Continuous Innovation: Enabling New Product Introduction while Ensuring High Quality
Track: Product Quality & Manufacturing Innovation
Wednesday, September 24, 9:00-10:30 a.m.
Room Location: Washington 2
The business strategy of “Time to Market” has historically defined competitive success. “Time to Volume” is the operational translation, driving operations to keep pace with the marketing strategy. In the 21st Century, however, these concepts have evolved to a new paradigm – “Time to Profitability” – which has emerged from the dynamic market forces in today’s flat world. As innovation accelerates, the ability to derive profit from innovation is the new competitive imperative. It is no longer enough to be first to market or first to volume, you must be first to realize the highest quality product in sufficient volume to acquire and retain profitable market share. Innovation induces variability in the value chain, increasing the opportunity for failures. As an enterprise expands globally, the possible points of failure also increase. As a result, risk increases with the rate of innovation and globalization. Medical Device companies must invest in technology that enables seamless end to end processes and provides a framework for business transformation with manufacturing and quality at the center. This track will define “Closed-Loop Quality Execution” as the enterprise end-to-end business process surrounding manufacturing and quality operations, which accelerates product innovation while rapidly optimizing quality. Quality Execution lies at the intersection of the Innovation Lifecycle and the Value Chain. It is where quality transpires, and where quality deviations are discovered, corrected, and prevented, resulting in reduced risk at every level of the innovation cycle.
Moderator: Daniel R. Matlis, President, Axendia
Panelists:
Dana Saylors, Senior Director, Industry Marketing, Camstar Systems, Inc.
Marc Halpern, Ph.D., Research Director, Gartner
The DNA of Selling and Marketing High-Risk Innovation
Track: Business Development / Finance
Wednesday, September 24, 10:45 a.m.-12:15 p.m.
Room Location: Washington 5
We’ve seen it happen all too often. There is a new or underleveraged clinical solution that has the hopes of the organization riding on it. The offering is technologically innovative; it meets a clear market need that exceeds clinical understanding and has the potential to leapfrog the competition. Meanwhile, sellers see their window of unique opportunity closing as competitors plan to quickly replicate. There is intense political and economic pressure to drive down soaring healthcare costs.
Many times a clinically “satisfactory” solution is surpassed by the perceived costs of change. Clinicians see potential risks in the product; extra time to learn, new techniques, etc. So why is it that some healthcare sellers are successfully able to create enough insight for change while others are not?
In this session, the author of this groundbreaking research and a panel of medical technology executives will present their findings and discuss the keys to successful product launches in today’s marketplace.
Moderator: Mr. Steve Lunz, Vice President, Direct Sales, Huthwaite
Panelists:
Chris Mitchell, Director Global Accounts, Direct Sales, Huthwaite
Connie Mardis, M.Ed., Head of New Product Marketing Education, Siemens Healthcare Diagnostics
China’s Healthcare Reform: Solving Problems or Creating New MedTech Woes?
Track: Global Business Issues
Wednesday, September 24, 10:45 a.m.-12:15 p.m.
Room Location: Wilson BC
China’s leadership is moving aggressively to reform its healthcare system. The results promise to bring more government and private-sector funding to the healthcare sector, but the leadership’s focus on cutting costs threatens to limit access to the most technologically advanced medical products. This panel will examine the political pressures underlying the drive to reform, examine the likely outlines of the new healthcare policies, and assess the impact on the medical device and health care industries. The panel will include a discussion of procurement policies as well as Chinese mechanisms to provide health care insurance and improve the quality and quantity of health care provided to Chinese citizens.
Moderator: Nancy Travis, Vice President, Global Strategy, AdvaMed
Panelists:
Yanzhong Huang, Ph.D., Associate Professor & Director, Center for Global Health Studies, John C. Whitehead School of Diplomacy and International Relations, Seton Hall University
Judy Zakreski, Vice President, U.S. Operations, Chindex International, Inc.
Stephen J. Trevisan, CEO & President, Accelovance, Inc.
Maximizing Commercialization: Integrating Regulatory & Reimbursement Clinical Trial Solutions for New Orthopedic Technologies
Track: Medical Technology Product Innovation
Wednesday, September 24, 10:45 a.m.-12:15 p.m.
Room Location: Washington 1
Data needed for a successful regulatory approval does not necessarily encompass the data needed for successful reimbursement of a product. The underlying reasons for this dynamic are the interests required to be satisfied within the different constituencies. The common bond for bridging this gap is the design and collection of clinical data, which accounts for both regulatory and reimbursement considerations. Consequently, these disparate needs may be solved with an integrated and well-thought out regulatory and reimbursement strategy that is planned and well executed.
Moderator: Chris Cerone, Vice President, Government Affairs, Zimmer, Inc.
Panelists:
Bob Durgin, Corporate Vice President, Global Quality, Clinical & Regulatory Affairs, Biomet
Eric Rugo, Senior Director Health Policy & Reimbursement, Stryker Orthopaedics
Charles Schneider, Vice President of Reimbursement, Musculoskeletal Clinical Regulatory Advisers, LLC
Contract Manufacturing: Managing Supplier and Outsourcing Partnerships
Track: Product Quality & Manufacturing Innovation
Wednesday, September 24, 10:45 a.m.-12:15 p.m.
Room Location: Washington 2
According to recent research from Covington Associates in Boston, MA, medical device outsourcing is increasing a rapid rate. In the United States, 20 of all OEM manufacturing was outsourced to third-party vendors in 2005, resulting in annual market growth of 26% to $4.4 billion, up from $2.2 billion in 2002, according to Covington. The firm also predicted that as much as 40 of all device sector manufacturing could be outsourced by 2010, leading to 15% annual growth. Outsourcing device manufacturing allows firms to focus on core competencies and reduce costs. Everything from clinical trials, design and development, component manufacturing, packaging, sterilization, electronic manufacturing services, etc., all the way through total product assembly, packaging and shipping are available to OEMs. This is particularly beneficial to start-up and midsize firms that don't have (want or need) a manufacturing infrastructure. Managing the different pieces of the puzzle--multiple suppliers, quality issues, design and product changes, recalls, just to name a few--means a new set of challenges, however, for both parties. This is particularly timely as the FDA and GHTF begin to more closely scrutinize suppliers and institute stricter supplier audits. This session is designed to educate companies of all sizes about how to use outsourcing to their maximum benefit, what combinations and processes work best and how to create a true contract manufacturing partnership from start to finish. Speakers will include device company representatives, suppliers and industry consultants.
Moderator: Christopher H. Delporte, Group Editor, Medical Product Outsourcing Magazine
Panelists:
Chris Olesky, President, ATEK Medical
David R. Busch, Principal, PRTM
Philip A. Borden, Principal, Riverside Partners