Leading the Effort for Rational Reform

Q&A

These are politically volatile times for the medical device industry. Some type of healthcare reform is likely to come. There are those who blame medical technology for rising healthcare costs. Industry is increasingly under fire over conflict-of-interest issues and product-safety concerns. The prospect of laws being passed that punish the device industry and hinder patient access to advanced medical technology is very real.

One of the people who will be most responsible for making sure that doesn't happen is Michael Mussallem, chairman and CEO of Edwards Lifesciences Corp. (Irvine, CA). In March, he was voted to a two-year term as the chairman of AdvaMed's board of directors. As the United States' largest medical device trade association, AdvaMed is chiefly responsible for making sure that the industry's interests are understood and respected among lawmakers, and that the industry is perceived as part of the solution, not part of the problem. As chairman of the organization, Mussallem is one of those responsible for making sure it goes about those tasks the right way.

Mussallem has led Edwards, a world leader in heart valve technologies, since it was spun off from Baxter International Inc. in 2000. He joined Baxter in 1979 and held various positions in engineering, manufacturing, and product development before ascending to management. Before the Edwards spinoff, he headed Baxter's cardiovascular and biopharmaceuticals businesses. He has been involved with AdvaMed for many years, having chaired the board's Payment and Health Care Delivery Committee and the International Committee. He spoke to MD&DI Editor-in-Chief Erik Swain shortly after being named to head AdvaMed.

Q: In your opinion, what are the most important issues facing the medical device industry today?

A: There is a great sense that the healthcare system needs to be reformed. Three crucial issues that need to be addressed are: that costs are escalating at an unsustainable rate, that the quality of care is not uniform, and that access to care is a problem for some patients. There is also a lack of understanding of the role our industry plays in the system and a misconception that medical technology is a contributor to rising healthcare costs. We have a clear sense that government will take some action on these issues. It is important that our point of view is heard and understood as we all try to develop solutions for these difficult issues.

Of these, I would say that cost is the single biggest issue because the current rate of increase is unsustainable. In line with that, there is a misconception about how the medical device industry contributes to costs. Recently, a study was published by Roland “Guy” King, former chief actuary at CMS, that showed only 6% of total national healthcare costs are related to medical technology, and the rate of increase of these costs is much less than the CPI [consumer price index] or medical CPI. So I'm a firm believer that our technologies can help produce solutions to these issues.

Q: What would you like to see AdvaMed accomplish over the next two years?

A: Given what we were just talking about, I believe that significant changes will be enacted around the world. Legislation will be passed that affects the funding and delivery of healthcare. As these changes take place, we hope that access to care and new technology get protected. We have to make sure that the things about which patients care most are also protected. Safeguarding these aspects of healthcare could be our greatest accomplishment. But to do so, medical technology has to have a seat at the table while the issues are being debated.

In two years, I would like the climate for medical technology to be just as good, if not better, than it is now. I would also like for all stakeholders to understand the importance to industry of driving innovation and encouraging new technology.

Q: AdvaMed in recent years has stressed the importance of educating the public, press, and policymakers on the value of medical technology. Is this message being heard? What more does AdvaMed need to do to ensure that this issue reaches the right audience?

A: Yes, I believe the message is being heard to some extent, but it needs to be heard more. One way we are doing this is with our Value of Technology campaign. We began a program to educate key policymakers about the value of medical technology. I am proud of what we have accomplished so far. There is a significantly better understanding in Washington, DC, than there used to be.

Having said that, we need to do even better. We need to expand the ways in which we carry our message. We need to tap more resources that can help us, from caregivers to patients to the employees of our companies. We need to communicate more stories about how medical technology can improve and prolong lives. Our nonprofit group, InHealth, funds academic research to demonstrate the impact of medical technology on science, on costs, and on the well-being of patients. This is the kind of fact-based, objective information that we need to be leaders in this debate. We need to be out front. We cannot let the story come to us, or be passive observers.

Q: AdvaMed has a Code of Ethics that has been widely adopted. Yet many conflict-of-interest issues are still in the forefront, as evidenced by the negative press of late. Is industry getting the message? What more can be done to make sure it does?

A: As an industry, I believe we took a positive step when we adopted our Code of Ethics. We even put it in place before the public became vocal on this topic. But clearly, public expectations keep rising. Patients are far more aware of and skeptical about conflict-of-interest issues than they used to be. They worry about the self-interested people in the healthcare system. It is important that we increase our transparency to live up to and match the expectations of the public. We will try to be consistent in terms of physician-payment disclosure. We have to work to clarify and help others understand the complex issues in this area. Our logo-licensing program can help raise such awareness.

We consider this code a living document that should effectively evolve with the needs of patients during these trying times.

Q: As chair of the board committee on payment and healthcare delivery, you worked to ensure that CMS's proposed changes in payment structure did not impede patient access to medical technology. Does the denial-of-access problem remain a threat, and if so, on what fronts?

A: Yes. Any issue that could impede patient access to care is of significant concern. As government tries to control costs, there is always the chance of reducing patient access to care.

For example, there is a comparative-effectiveness program that is being launched this year. We support comparative effectiveness. It can produce helpful data on clinical outcomes and get the word out about the most effective technologies. But the potential exists for a one-size-fits-all practice of medicine that can compromise the quality of care, since there is no such thing as an average patient. We must protect the ability of physicians to use their best medical judgment about individual patients. If the comparative-effectiveness program turns into a cost-effectiveness one, that could be at risk. We want informed medical decisions, not the replacement of medical judgment with a national formula for patient care.

Fulfilling unmet patient needs is what drives our industry. We must work closely with physicians to learn about what can help their patients. That is one reason we have to protect our current relationships.

We are engaged in the debate about what to do about rising healthcare costs. We need a more-efficient healthcare delivery system that doesn't sacrifice quality of care. We want to engage stakeholders in debate, even in the presidential campaign.

Q: When you were elected chairman of AdvaMed's board of directors, you said you want to “strengthen relationships with key stakeholders on a global basis.” What exactly do you mean by that, and how can it be accomplished?

A: Healthcare is such a broad issue, as there are so many facets to the healthcare system. For us to succeed, we need to strengthen our relationship with key stakeholders. Those include patient groups, physician groups, other industry associations, hospitals, the biotechnology and pharmaceutical industries, and anyone else interested in rational reform.

If we are successful in showing how dedicated we are to patients, we will be respected for who we are and for what we do. If we are able to develop relationships based on that, it could result in something like a grassroots campaign that will drive us to have even more influence as we try to shape the debate.

Q: FDA has come under fire for a perceived failure to protect the public health. Does the agency need to be strengthened, or are the problems overblown? Does it have what it needs to accomplish its mission?

A: We believe that a strong and healthy FDA is very good for our industry and the patients that we serve. We support greater FDA funding. FDA has a tough job. Keeping up with the task of protecting the health and safety of the public, while also keeping up with today's pace of rapidly evolving technology, is a huge challenge. With the increased demands of a more educated public, that has gotten to be more of a challenge than ever. We need the agency to be reliable and thorough, but also responsive.

The [FDA Amendments Act] included provisions to strengthen FDA's funding and some of its programs. That is an important step to helping it accomplish its mission. Increasing funding for FDA should help [the agency] keep up with the increasingly sophisticated medical technology that is playing such a vital role in patient care.

Q: The Senate just passed a resolution that would increase FDA's budget by $375 million. Is such an increase needed? Will it become a reality?

A: I don't have any insight in terms of its chances of passing [both houses of Congress and being signed into law]. We think it is very enlightened of the Senate to take that stance. People's expectations for FDA continue to rise. It is taking on additional duties in terms of ensuring food safety. We have to make sure that as that role expands, and that it does not take away the energy and
resources [the agency needs] to approve and evaluate medical technologies.

Q: AdvaMed's membership reflects the extreme diversity of the device industry. How can you get such a diverse group aligned toward common goals?

A: Diversity is one of the greatest strengths of our industry. It means there are many ways in which we can help each other. Small companies certainly benefit from being affiliated with larger companies that have a global footprint, vast resources, and extensive experience with various issues. There is a lot that large companies can teach to small companies. At the same time, larger companies benefit from being associated with small companies, because of their entrepreneurial spirit, the new products they develop, and the new jobs they create. So I believe that all types of companies can learn from each other. Edwards is in between; we are neither very large nor very small. Given our medium size, we may be in a nice position to help determine common ground.

AdvaMed has established itself as a thought leader. It is well positioned to be ahead of the curve and shaping the debate on issues. It will be a major player in the reform of healthcare, and I'm proud to be part of that.

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