Changes in health care's regulatory landscape could have a negative effect on device innovation. In the following exclusive interview, James Mazzo, newly appointed chairman of the Advanced Medical Technology Association, along with AdvaMed president and CEO Stephen J. Ubl, discuss with Medtech Insight the hurdles facing the medical device industry today.
Article preview from Medtech Insight- April 2010
The next few years could prove to be some of the most interesting—if not volatile—years the US medical device industry has seen in a while. From historic health care reform legislation signed into law in March to pending changes to the submission process for new product approvals, the business of health care is experiencing some major changes. Ironically, these developments come at a time when a number of device makers are producing some impressive and sought-after technology.
The fear is that the changing regulatory landscape could have a negative effect on innovation, and that is the main concern for James V. Mazzo, newly appointed chairman of the board of directors for the device industry trade group the Advanced Medical Technology Association (AdvaMed). In the following exclusive interview, Mazzo, along with AdvaMed president and CEO Stephen J. Ubl, discuss the hurdles facing the medical device industry today.
Mazzo, also the senior vice president of Abbot Medical Optics Inc., says the industry will have to deal with the current issues, but he emphasizes that in doing so, manufacturers cannot lose their focus, which should remain on developing and supplying products that contribute to patient care. Likewise, Ubl noted that device manufacturers will always face challenges, but the strength to deal with those challenges comes from maintaining unity and focus.
Mazzo also acknowledged that not every AdvaMed member was completely happy with the association's efforts to beat down an excise tax for devices sold beginning in 2013—an allusion to St. Jude Medical Inc., which withdrew its membership from AdvaMed in November 2009 after expressing disagreement with the group. But the AdvaMed executives stressed that the tax had originally been much higher and would have cost the industry $40 billion through 2019 without negotiations that brought the tax down to an estimated $20 billion.
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