NAPLES, Florida – As in the past, this year's annual meeting of the Advanced Medical Technology Association (AdvaMed; Washington), which concluded on Saturday at the Ritz-Carlton Naples Golf Resort, did not produce much “stop-the-presses“ news. But also as in the past, it served to indicate the industry's major concerns and a sort of bellwether of current industry thinking.
Thus, nine years ago – when this publication was first launched as Medical Device Week – the main issue, and a source of loud complaining, was the FDA and its seeming tardiness in granting market approval to new products.
Then and throughout the rest of the 1990s, association presentations featured graphics and PowerPoints serving to demonstrate the agency's inability to meet its own mandated timelines for accepting, reviewing and then issuing decisions – usually followed by FDA staff presentations promising improved future performance and closer collaboration with industry.
Over the past five years, the ground has clearly shifted (perhaps, we would suggest, with the introduction of device user fees and, maybe, the assumption that if the agency is expected to do more, it also will demand more financial help from the industry.)
During that period, the focus of AdvaMed and the industry has turned to the Centers for Medicare & Medicaid Services (CMS; Baltimore) and its tardiness in expanding coverages for new technologies and for new applications of existing technologies.
The 2006 edition of AdvaMed's annual meeting suggested another ground-shifting alteration in focus, primarily and more broadly to what happens to a medical device after it has won clearance or approval – by the FDA, by governmental policy makers, and in both the domestic and foreign markets.
These were the key issues mulled over at the gathering, with both AdvaMed and government representatives laying out much broader action agendas than they have previously, in response, we would suggest, to events that unfolded over the past year.
• On post-market issues:
New AdvaMed President Steve Ubl, in his inaugural address to the group, emphasized the “pressure“ being felt by the FDA to put in place “tougher post-market controls.“ And he said this should be done by demonstrating the need to support the value of medical devices with more specific and supportable evidence.
And Ed Ludwig, president and CEO of BD (Franklin Lakes, New Jersey) and incoming chairman of AdvaMed, in his presentation, clearly underlined this point.
“[W]e must commit to candor and transparency in all we do, including how we interact with doctors and other healthcare providers and in how we report post-market information,“ he said.
“Currently, we're actively engaged in discussion with the FDA on issues stemming from recent events“ – a rather clear allusion to the multiple implantable device recalls of 2005 – “and we have created working groups to focus on conditions of approval, recalls, reportable events and quality systems.“
And this was even further underlined on the meeting's closing day by a review of postmarket emphasis from Daniel Schultz, MD, head of the agency's Center for Devices and Radiological Health, with references to “targeted surveillance,“ additional “third-party inspections“ and the standard calls for collaboration with the industry, this time though concerning issues of “postmarket safety.“
Significant by their absence were the usual debates concerning meeting regulatory timelines.
• Marketing via value, marketing via quality:
An underlying debate was seen in AdvaMed's use of the word “value“ to describe the benefit of medical technology vs. the frequent use of the term “quality“ by Mark McClellan, the former FDA commissioner who now heads up CMS.
For AdvaMed, the world “value“ refers to the longer-term benefits of medical devices and technology and what they bring to patients by returning them return to work and contributing to family and society. For the government, the word “quality“ appears to indicate the shorter-term benefits in terms of cost savings. And look for these terms in the coming months to identify the line in the sand separating the two camps.
Thus, Ubl said that a key focus of the association will be to “aggressively define“ the standards that will guide “value-based purchasing“ of new medical devices and technologies. Without these standards, he said, the “peril“ will be “the federal government micro-managing the process by determining which products to use.“
And Ludwig said, “the tendency for some [is] to focus on unit cost vs. value delivered. While there may be high up-front costs for our products, there is long-term value in lives saved and improved, and in systemic cost reductions.“
Serving to highlight this difference – and striking the lone spark in this otherwise sedate gathering – was McClellan in a telephone presentation from Washington (the agency's satellite video connection being on the fritz).
McClellan gave his usual rapid-fire presentation, more than a dozen times emphasizing improvement of quality “at lower cost.“ And then, deep into this presentation, he rather off-handedly said that AdvaMed's “leadership is opposed to better quality of care“ through paying for more services. And he urged the association “to work with us to support new medical technologies that improve the quality,“ based on demonstrated outcomes.
Responding to this rather sharp dart, Mike Mussalem, president and CEO of Edwards Lifesciences (Irvine, California) and moderator of the session, clearly had to bite his lip in a conciliatory return of McClellan's serve.
“Our goals are largely aligned with yours to deliver value for patients,“ he told McClellan. “We are committed to work with you in a positive way.“
So far, that work has been the association's call for clear limitations on the agency's pilot project to demonstrate the value of gainsharing.
Stay tuned for further quality-vs.-value debates.
• On the domestic front:
In his presentation, Ubl promised a larger public relations effort to the general public by “doing a better job of telling the patient part of this [value] story.“ This would be done with a series of advertisements presenting “case studies of individuals, celebrities, even members of Congress who have benefited from medical technology.“
Ludwig referred to this effort as the association's “'Value of Technology' initiative,“ and that this initiative “is on its way to changing the public perception of our industry as we showcase our many positive contributions to health around the world.“
And he emphasized AdvaMed members' commitment to the association's “Code of Ethics,“ as a way of encouraging “consumer confidence“ – but without referencing a growing number of charges during 2005 of unethical behavior by some companies.
• On the international front:
It appeared at this edition of the association's annual gathering that the group's presentations were targeted somewhat more, though not greatly so, to international concerns, probably driven more by the growing threat of avian flu than ongoing security and terror concerns.
Thus, Ludwig referred to the “globally connected world [that] presents additional challenges. Diseases do not respect national boundaries, nor do some of today's most vexing healthcare policy problems. Policymakers around the globe need to meet not only in times of crisis, as they're doing to prepare for a potential flu pandemic, but also more regularly to address healthcare policy issues.“
Overall, the 2006 AdvaMed meeting appeared to lay out the parameters of an association report card that will be useful in judging its activities over the short term before the ground shifts again to new issues.