Medical Device Execs Weigh in on Comparative Effectiveness

During a recent conference call organized by the Advanced Medical Technology Association (AdvaMed) in Washington, D.C., medical device industry executives voiced their support for a comparative effectiveness program that received $1.1 billion in the recently passed economic stimulus bill, as long as it doesn’t always result in the cheapest method used and innovation isn’t discouraged. Comparative effectiveness measures cost effectiveness and clinical benefits of competing treatments. Historically, when companies came up with a new technology or drug to deliver care, all they had to produce was clinical data to show its efficacy. Now, the Comparative Effectiveness Institute, a new regulatory body, may be created to evaluate economic data – in other words, how much the new technology would cost Medicare and how much cost savings it would bring over the long term.

“We can’t afford a cheapest-at-best approach to medicine,” said Bill Hawkins, chairman and chief executive of Minneapolis, Minn.-based Medtronic Inc. “Cheapest in the short run is not necessarily the best value for patients over the long term.”

Executives from Edwards Lifesciences Corp., Becton Dickinson & Co., Advanced Medical Optics Inc., Medtronic and other device companies said they want to make sure their voices are heard on healthcare changes.

Stephen Ubl, president of AdvaMed, said the industry is concerned that putting a focus on healthcare costs will result in the stifling of medical innovation.

“We must guard against an innovation blind spot,” Ubl said. Ubl cited a University of Chicago study that found the economic benefits to continued advancements in medical technology are substantial. He note improvement in life expectancy from cardiovascular care added about $2.6 trillion per year to the national wealth from 1970 to 1998.

The FDA’s oversight of the medical device industry has been under scrutiny recently. A group of agency scientists wrote to then-President elect Barack Obama and members of Congress about how the medical device approval process is flawed. The Government Accountability Office, the investigative arm of Congress, issued a report last month saying some of the most risky medical devices have not been carefully reviewed by the FDA before they went on the market, and that the agency should take corrective action swiftly.

Medtronic’s Hawkins denied that legislators and industry players are at odds over this issue, which may increased the cost burden on companies developing new therapies and devices.

“I would comment that in fact that we have endorsed the concept of comparative effectiveness and in fact it is very much what our industry does every day when we go and present our products and comparing what we do versus other products,” Hawkins said.