Medical Device Daily Washington Editor
WASHINGTON — Tuesday served as the last day of CRT (Cardiovascular Research Technologies) 2010, sponsored by the Cardiovascular Research Institute (Washington), and included a lunchtime discussion session offering views of how healthcare reform might affect the device industry, but a previous session gave Jeffrey Shuren, MD, the chief of the Center for Devices and Radiological Health, a chance to further explain where he expects to steer the center in the next couple of years.
Shuren observed that "the landscape of device evaluation is always moving," but promised that "some steps CDRH is taking," will result in "clear and predictable regulatory pathways." He added that he sees "some challenges" as to how to ensure safety and effectiveness "when the science is continually evolving [and] devices are becoming more complex," adding that devices "are evolving faster than people are."
This high pace of evolution makes devices and diagnostics "unique among medical products" and forces CDRH to "change our course accordingly," Shuren said. Hence, CDRH will not change its approach to regulatory review "on an ad hoc basis," but Shuren seemed to forecast at least some continued unpredictability with the remark that he sees an "unavoidable tension between predictability and adaptability."
Among the speakers during the lunchtime session addressing issues related to healthcare reform was Sean Salmon, VP and general manager for Medtronic Cardiovascular (Minneapolis), who noted that the firm had prepared for reform only to watch it crumble last month. Still, he said, the idea is not necessarily kaput. "It certainly looks like a tall hurdle for anything to pass in the near term," he acknowledged, adding that even industry realizes that "the system we have today is unsustainable."
Salmon cited both the numbers of uninsured and the share of GDP that goes to healthcare as imperatives for reform, but described the current crop of healthcare reform proposals as "health insurance reform, largely." The issue of how to pay for it all "gets into some interesting NIMBY [Not In My Back Yard] issues," he observed, adding that for the device industry "that excise tax ... on top of Medicare cuts" will force lower prices, which he said is an almost a certain outcome in the long run in any event.
Another point of pressure for industry, Salmon added, is that "it doesn't appear that the increased number of patients coming into the insured pool will offset" the device tax and the proposed Medicare cuts.
Salmon said that bundling is a practice Medtronic supports "as long as we don't have a disincentive" to use the appropriate technology, and said that most devices offer a good economic argument, even if a couple of iterations have to pass before some of those values surface in a particular design. He said that the cost of therapy for implantable cardioverter defibrillators "has come down dramatically," even as those units shrank physically as well.
As for physician payment sunshine, Salmon said, Medtronic supports federal government involvement even if only because "it's going to preempt state level reporting."
Salmon observed that the driver for innovation has traditionally been "necessity or unmet need," but that innovation was always fueled by capital. "We can see record declines in venture funding," which he said translates into an environment in which "getting funding ... is nearly impossible." He added that the National Venture Capital Association (Arlington, Virginia) recently reported a 27% reduction in venture capital for devices.
"I believe that medical devices can be part of the solution" Salmon said of the healthcare spending problem, closing with the remark, "it's just a matter of using your imagination."
Steve Nissen, MD, of the Cleveland Clinic (Cleveland), highlighted "how bad a pickle we're in" where U.S. healthcare spending is concerned. The frequent critic of the pharmaceutical industry said that a comparison with other OECD (Organization for Economic Cooperation and Development) nations shows that the U.S. spends $650 billion to much, adding that if healthcare reform "does put a chill in innovation, you have to understand we put ourselves [in this situation] by our behavior."
Life expectancy comparisons do not suggest that Americans are getting much bang for the buck, Nissen hinted, adding, "we're a little better than Greece and Mexico" in terms of longevity, but otherwise the U.S. still compares poorly to most other nations in the spending/outcomes dynamic.
Nissen said drug overspending comes to $90 billion a year and pegged the figure for devices at $26 billion a year. "It's primarily over-utilization" that drives excess healthcare costs, "and medical devices are part of the problem," he said, adding that Americans are "twice as likely to get" percutaneous interventional treatments than the European average and "more likely to get knee replacements." As for how innovation is financed, he said "it's our patients who are supporting it."
"Why is there reform coming? Because we cannot afford to continue to do this and insure all our citizens," Nissen charged. Reimbursement "is what drives over-utilization," he said, adding that cuts to Medicare spending are the only mechanism that can trim the Medicare budget. The U.S. government, he claimed, "really has no other options."
On insurance and administration, Nissen claimed, "we spend $85 billion more than we should," which "amounts to about 29 cents on every dollar." By comparison, Medicare's administrative overhead is about 3%, he stated, a figure that has been disputed recently. "I think that the regulatory system needs an overhaul," Nissen argued, claiming that "the vast majority of 510(k) approvals" do not meet the regulatory standards for approvals, but offered no explanation for this statement other than to note that Congress "never intended the 510(k) program to be used the way it's used today."
"Fundamentally, they have a back-door approval process," Nissen alleged, which he said has evolved "to the point where it's the primary way devices get approved." He said that intravascular ultrasound was cleared rather than approved via a PMA "because it was [purportedly] just like measuring pressure in the coronary arteries" via another technology. He argued that there is "considerable evidence that 510(k) devices are much more likely to be recalled" than PMAs, and made the case for an approach to new device development that would result in devices that are good enough rather than superlative.
Panelist Bill Maisel, MD, of Beth Israel Deaconess Medical Center and the Medical Device Safety Institute (both Boston) said of Nissen's remark about devices that are good enough: "The concept of [such devices] being the future of U.S. healthcare is not going to fly." He argued that no doctors "will purposely pick up a device that offers less for that patient," asserting, "we need to get better at bringing products" to markets with less expense. "We need to do better with bench testing," for example, which will require "figuring out where it's useful and where it's not."
Nissen said in response, "I think its great to have fancy and expensive devices that do more," but "where's the evidence? That's the reason for CE research." He called for "more studies on are there patients who will do just as well?'" with the less expensive devices.
Mark McCarty, 703-268-5690