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| AdvaMed SmartBrief |
| December 18, 2008 |
Looking forward to 2009
Part I of this AdvaMed SmartBrief special year-end report looked back at the most important trends and stories of 2008. Part II, below, highlights several predictions -- including from Edwards Lifesciences Chairman and CEO Michael A. Mussallem and AdvaMed SmartBrief readers -- for what's expected in 2009.
From my perspective, the upcoming year will present many challenges and opportunities for the medical-device industry. Medical-technology companies, as well as the FDA, must strive to educate consumers about device-safety procedures and regulations and make sure that compliance and device safety retain the highest priority. In the area of policy, health care reform legislation is likely to gain attention as President-elect Barack Obama and his administration begin their term in January, and the industry should continue to seek reimbursement policies that recognize contributions from new technologies and innovations.
As for events, the first half of the year promises the 2009 International Medical Device Industry Compliance, Regulatory & IP Conference in Rome and several Medical Technology Learning Institute seminars in Orlando, Fla. Visit the AdvaMed Web site for full details.
| Do you expect China's recently announced health care reform to affect your business there, either positively or negatively? | ||
| Yes | 50.88% | |
| No | 29.82% | |
| Maybe | 19.30% | |
| What issue should receive the most attention from the industry in 2009? | ||
| R&D investments in a strained economy | 42.35% | |
| Addressing ethics and compliance concerns | 30.59% | |
| Expansion into international markets | 14.12% | |
| Mergers and acquisitions | 8.24% | |
| Other | 4.71% | |
| What do you think was the top issue in the medical technology industry in 2008? | ||
| Ethics and interactions with physicians | 54.72% | |
| Health care reform | 21.70% | |
| Comparative effectiveness research (health care costs) | 12.26% | |
| Federal pre-emption of PMA products | 7.55% | |
| Patent reform | 3.77% | |
An interview with Edwards Lifesciences Chairman and CEO and AdvaMed Board Chairman Michael A. Mussallem

AdvaMed SmartBrief editor Ashley McMaster corresponded with Edwards Lifesciences' Michael Mussallem to get his thoughts on what direction the medical-technology industry is headed in 2009.
What do you consider the top three trends in the medical-device industry in 2008?
This year we've seen a continuation of a trend in the development of products that are less invasive, to minimize complications for patients. We're also seeing a demand for our industry to address safety and ease-of-use challenges that have been raised by hospitals and clinicians that struggle with increasing workloads and higher expectations from the public. And a trend that is rapidly gaining more attention is an emphasis on transparency in our industry's relationships with clinicians.
Going forward, what do you see as the greatest opportunity and greatest challenge facing the medical-technology industry within the public-policy arena?
One of our greatest opportunities we face -- in light of the current economic and fiscal environment -- is to support investment in expanded access to new technologies for patients. We have a great conviction that technology can create long-term cost savings to the health care system, and we need to make our case to policymakers that we are part of the solution.
A major challenge we face is the increasing lack of public tolerance for risk. Medical devices inherently carry some risk. While most people would agree that the benefit of medical devices greatly outweighs their risk, public sentiment has been turning toward a zero-risk expectation. Our burden in meeting this challenge will be twofold: 1) maintain our drive toward minimizing risk associated with our products as we continually raise our own bar for safety; and 2) working with clinicians, patients and the general public to help them understand the need to accept some basic measure of risk.
Health care reform will be on the table in some form with the next administration and Congress. What does medical technology bring to the debate and where do you see the opportunities for the industry in helping to craft meaningful reform?
Health care reform is a priority issue for us -- we believe that health care reform is necessary and doing it the right way is critical.
We believe that medical technology can play an important role in helping improve efficiencies in the health care system. This is particularly important as there will be increased pressure on our system to afford a large expansion of health care coverage.
Last year, AdvaMed unveiled a nonpartisan plan for providing universal health insurance coverage to help shape the national debate and continue our leadership in the broader health policy debate. Key points of AdvaMed's plan include access for all Americans and an increased focus on investments in technologies that prevent disease and improve quality of life.
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