James Mazzo’s busy life now includes serving as one of the point men for his industry in the halls of Washington.
Mazzo, president of Santa Ana eye surgery and contact lens care company Abbott Medical Optics Inc., a unit of Abbott Laboratories, is settling into his role as chairman of AdvaMed, a Washington, D.C.-based trade group.
AdvaMed lobbies governments on be-half of medical device makers and includes a range of companies, from big to small. Some 70% of its members have less than $30 million in yearly revenue.
The group was among several that had a seat at the table during healthcare reform and managed to reduce a medical device tax through its lobbying.
Mazzo succeeded Michael Mussallem, chief executive of Edwards Lifesciences Corp., the Irvine heart valve maker, as AdvaMed chair.
Business Journal healthcare writer Vita Reed asked Mazzo about AdvaMed’s priorities and concerns regarding its industry. An edited version of his comments follows.
What sort of changes does the industry have to make in order to adapt to this new reform era?
The medical technology industry has long supported comprehensive healthcare reform that will ensure quality, affordable healthcare coverage for all Americans. When the legislation is fully phased in, about 32 million more Americans will have insurance coverage and improved access to care, including advanced medical technologies. The major upside of healthcare reform is the societal benefit of increased coverage.
For my industry, some of the most significant changes included in healthcare reform are the new Medicare payment methodologies, which place a premium on quality and efficiency.
The industry will be monitoring how these new payment methodologies are implemented to ensure that patients have access to appropriate care and new technologies. For example, if incentives for efficiency in the payment system are not designed carefully, they could discourage early adoption of new treatments that will ultimately deliver much better results for patients.
To succeed in this new environment, companies will need to think strategically and build cost and comparative effectiveness data into the product development process.
What are some of the key international medical device issues that AdvaMed is dealing with?
AdvaMed is working hard to ensure balance as countries consider new regulatory proposals. We believe the goal should be systems where patients have timely access to safe, effective new products.
Regulatory hurdles are getting higher in many countries, which can have the unintended consequence of creating unnecessary delays in patient access to new medical technologies.
For example, the European Commission is developing legislation that will substantially alter how medical devices are regulated in Europe.
AdvaMed is working with our sister associations in Europe to ensure that the new system continues to allow for the introduction of safe, effective products without establishing new layers of bureaucracy that delay access.
AdvaMed also is looking at the Chinese regulatory system.
China is a major priority and we have two key concerns.
The first is a country-of-origin registration requirement for imported products that would prevent a company from selling a product in China unless it is approved for use in the company’s home country. This has the effect of blocking the importation of any product not made specifically for the Chinese market.
We also are concerned about a draft requirement barring the use of foreign clinical trial data in the Chinese regulatory system.
Have regulatory pathways eased for device makers in places such as Japan, and what role has the association played in doing so?
AdvaMed’s efforts have helped address aspects of regulatory pathways in overseas markets that were inhibiting patient access to new technologies. Our efforts in Japan are an excellent example.
AdvaMed was instrumental in bringing to the attention of the Japanese government and people the “device lag”—the delay in introducing new products into the Japanese market compared to the U.S. and Europe. This was the result of an approval process that was not working for Japanese patients the way it was intended.
AdvaMed worked closely with the Japanese government to identify ways to reduce the device lag. These efforts resulted in the adoption of an action program by Japan to speed the product approval process.
How do you and your AdvaMed team make sure your interests are heard in Washington?
AdvaMed has a long history of bipartisan advocacy and we have always made a concerted effort to reach out to members on both sides of the aisle. Disease does not discriminate based on party affiliation and our advocacy efforts on behalf of American patients resonate with lawmakers at all points on the political spectrum.
Americans have an appreciation for technology, and members of Congress are no different. Generally, I find that people are eager for and expect the medical technology industry to continue to innovate, resulting in products that can provide earlier, more accurate diagnoses, better treatment options and ever improving outcomes.
One of the goals of our advocacy, however, is to demonstrate how policy decisions can either help or hurt our ability to continue to innovate.
Whether it is FDA regulation, Medicare reimbursement, access to international markets or tax policies that support medical progress, decisions on these issues can have significant impact on the industry. We work to promote policy that fosters medical advances so we can continue to improve the lives of patients.
