These are turbulent days in the healthcare industry, with healthcare reform—including a hefty tax on the device industry, the economic recession, and troubles at FDA all converging to make for tough times. Helping the medical device industry maneuver through the rough waters is the Advanced Medical Technology Association (AdvaMed) and its new chairman, James V. Mazzo.

Mazzo is president of Abbott Medical Optics, heading up Abbott’s global vision care business. He was appointed to his current role in February 2009. Mazzo served as  chairman and CEO of Advanced Medical Optics until it was acquired by Abbott. He also held various senior executive–level positions for Allergan prior to its spin-off of Advanced Medical Optics, including president of Allergan’s ­Europe/Africa/Middle East region. He has served on AdvaMed’s executive team for the past six years, most recently spearheading the association’s international efforts. He spoke to MD+DI editor-in-chief Sherrie Conroy shortly after being named AdvaMed chairman.

Q: There are many issues ­facing the industry right now. What is your vision for the ­future of the industry?

A: We’re always going to be facing issues. That’s part of our responsibility. But we never want to forget what we do as an industry. And that’s improving patient care through innovation. That’s our essence—that’s our reason for being. My goal as chairman is to always stay patient focused, ensuring that our innovation is not stopped, that it’s constantly improved under the rigorous standards that we have today across the globe. I also want to leverage our diversity. More than 70% of our member companies are $100 million or less. Sometimes when people think of the power and the strength of AdvaMed, they need to understand that our strength comes from our diversity. Having both large companies like Abbott and smaller entities is tremendously beneficial for this industry because we are able to get and support those divergent views.

Q: What are your primary goals heading into your term as ­chairman?

A: We have three fundamental goals that we’re going to be focusing on. First is supporting the FDA review process to ensure that patients continue to have timely access to safe and effective medical advancements. Second, as Medicare begins testing new healthcare payment and delivery system paradigms, we want to ensure that innovation thrives. Finally, we are focused on moving forward global harmonization efforts. We have to remember that we are a global industry. Many of our member companies to a large degree have operations across the globe. I led AdvaMed’s international efforts over the past couple of years and global harmonization, specifically in the Asian ­countries.

Q: Healthcare reform is undoubtedly on everyone’s mind. What guidance will you give to the AdvaMed ­membership and device industry as a whole ­going forward in order to address the tax on medical devices and other portions of the legislation that affect their business?

A: We continue to believe that this tax on medical devices is not positive for our industry. It’s going to present significant challenges for companies large and small. No matter what size, this will have a negative  impact on research and development and jobs. There’s no doubt about that. We definitely appreciate the efforts that we’ve had from many members of Congress on a bipartisan basis to mitigate the tax by cutting it in half. It was as high as $40 billion and now it’s $20 billion.

We’ve been able to delay the start date until 2013 and, in making the tax deductible, we’ve made huge strides. But let me make sure you clearly understand, we’re not pleased with this. This has impact on the innovation we talked about. It has a tremendous impact especially for small companies that are living day to day on their bottom line. So reduction of jobs and reduction of technology is not positive for our industry. We’ve long supported as an industry patient access to affordable health coverage. But having a tax of this nature will definitely affect our innovation and jobs.

Q: As healthcare reform dominates the news surrounding healthcare, what will AdvaMed’s approach be to get its voice heard by the public in terms of the value of medical ­technology?

A: First off, having an industry association like AdvaMed is so critical. As you can imagine, with the diversity of companies, you have diversity of opinions, which is great. That’s what adds value. Being able to have ongoing communication amongst all of our members allows us now to have a clear, concise message back to the Hill. AdvaMed’s value of technology education program will continue to spread the word to help policymakers and the public understand the benefit and value of medical technology. We can’t allow the average individual who picks up a newspaper or watches Good Morning America to forget what medical technology advances have been able to do. With all the different messages that they are being bombarded with, we want to make sure people understand the improved patient outcomes and cost savings for the healthcare system that are the results of medical innovation. We also want to spread the word about how our industry is a vital segment of the U.S. economy. We employ and we invest in R&D right here in the United States. Medical technology delivers tremendous value, and we need to be able to clearly articulate that in one message. It goes back to having a strong industry voice of hundreds of thousands of people across the country.

Q: How will you ensure that “innovation thrives as payers and providers experiment with new healthcare delivery ­models” as stated in AdvaMed’s recent press release?

A: We’ve got to ensure that early adopters are not penalized. We’ve got to prevent disincentives for more novel and more expensive products. There was an interesting study by the University of Chicago that found improvements to life expectancy from advances in cardiovascular care added $2.6 trillion per year to our nation’s wealth between 1970 and 1998. We’re adding to the nation’s wealth because we’re making people more productive. We want to make sure patient and physician choice in medical treatments is preserved so that these kinds of benefits can be realized.

Q: AdvaMed has issued its recommendations for improving the 510(k) process. What role does AdvaMed hope to have ­going forward?

A: First of all, there are some misunderstandings that this 510(k) process is broken and needs an overhaul. That couldn’t be further from the truth. We surely recognize that any process can be improved, but the basic structure of this process is sound and has stood the test of time. The 510(k) review process provides an extremely rigorous and efficient framework to really determine the safety and effectiveness of incremental changes to medical devices. Our objective is to maintain and improve the 510(k) as a viable path for both low- and moderate-risk devices and diagnostics. Our main concern is that you have an exaggeration and an interpretation that it’s severely broken. We want to improve, but let’s be careful of changing something that has stood the test of time. It has allowed innovation to pro­gress but never at the expense of patient safety. We’ve made several recommendations to the agency to improve the clarity and consistency of the 510(k) process. There’s an internal FDA review under way, and a longer-term review by the Institute of Medicine, and we welcome those reviews because we think they will clear up a lot of the misconceptions associated with the 510(k) process.

Q: You’ve actively led the charge to improve the ­medical device approval processes in Japan and China as well as in emerging markets. Will this continue to be a priority for you as chairman, and if so, what will be your next steps in these markets?

A: One of my key goals as AdvaMed chair is global harmonization. We can’t forget that a lot of our companies have product lines and entities across the globe. We were able to overcome an extremely difficult environment in Japan and now Japan is starting to take steps to address the device lag. Two years ago my predecessor, Mike Mussallem, would have told you this is a major concern for our industry. Now we’ve opened that channel of communication. It’s not perfect but it has changed tremendously. I am now more concerned with other Asian countries, specifically China. We are encouraged by the steps China has taken to reform its healthcare system to expand patient access. But we’ve got to ensure that the country’s new health system appropriately values advanced medical technology. It’s one thing to ensure that we have access, but we need to ensure that they appropriately value and support new innovative technologies. So, we’ve been urging the State Food and Drug Administration to follow internationally recognized practice and phase out of its country of origin requirement by accepting a variety of foreign clinical data. We want them to accept these clinical data and place a greater reliance on the quality management system approach. We’re seeing glimpses of hope but it’s still gives me a little bit of concern.

Q: This has been the toughest economic recession in years worldwide. What role will or can AdvaMed members play in helping the economy rebound, and moreover, in creating jobs?

A: We believe we are an extremely vibrant part of the U.S. economy. Our industry generates more than 350,000 jobs., and we pay 30% more than the average U.S. job. We employ and pay a high salary to those people because we know the high standards we must have as we deliver these products. Every medtech job generates an additional 4.5 jobs across the United States. It goes back to improving patient access to get out great technologies by allowing device companies to innovate, which leads to more spending on R&D and manufacturing jobs. We tend to use a lot of biomedical engineers, so engineering institutions such as the University of California, Irvine, and Purdue are a great source of employees. What we don’t want to have to do is curtail these jobs because of the device tax.

Q: FDA has been in turmoil over the past year and now has a new director, Jeffrey Shuren. What does the agency need to change (or not) to improve its image and work best with industry? What will be your ­approach for working with FDA to help it achieve its goals?

A: We definitely understand that FDA has a tough and important job. We have a lot of respect for what they do. A lot of our companies employ ex-FDA people so they bring those values and standards to our companies. It’s important in industry that FDA be seen as providing effective oversight, so a strong FDA means a strong industry. We will continue to work with FDA. We’ve always had open communications with the leadership at FDA. We just want to make sure that they clearly understand that patients need timely access to our technologies. We don’t want them to destroy or fundamentally change a system that has worked quite well in protecting American patients.

Q: What other priorities will you be focusing on over the next two years?

A: Another priority is AdvaMed Dx. We constantly are looking at ways to improve the association. And one of our new entities—and I give AdvaMed’s president, Steve Ubl, a lot of credit here—is this new division in AdvaMed focused exclusively on in vitro diagnostics policy issues and advocacy. Scott Garrett, chairman and CEO of Beckman Coulter, is going to lead this. It’s going to have its own C-level board of directors and its own staff. In vitro diagnostic issues have unique aspects apart from other devices. This new division will really be able to raise the awareness of [those issues]. We are looking to find ways to add more value for our members, and AdvaMed Dx is one of those. It provides AdvaMed with an enhanced value proposition for our members and a way to recruit new members, so it’s really one of those win-wins. I talk about our global harmonization; I talk about our ability to continue to innovate; I talk about our open communication with FDA. But having this new sector is providing great value to AdvaMed’s members and hopefully at the end of the day, it provides value to the consumer.