Heart-to-heart discussions about devices
The phrase "3D Symposium" may conjure up an image of a 3-D movie extravaganza. But the three D's stand for Dartmouth Device Development.
Key: It's an event dreamed up by Dr. Aaron Kaplan, a DMS cardiologist. He invites about 50 key stakeholders in the medical device industry to an annual retreat in Vermont. Attendees include leading clinical investigators; senior managers from medical device manufacturing firms; entrepreneurs; regulators, including the director of devices at the Food and Drug Administration (FDA) and his British counterpart; payors, including the chief medical officer at the federal Centers for Medicare and Medicaid Services; venture capitalists; investment bankers; and lawyers. The group spends a couple of days candidly discussing the development and commercialization of medical devices.
"The idea is you bring these folks together who are often transacting business—I don't like to say this—on opposite sides of the table," says Kaplan. "This is very unusual, providing a forum for people [who are] working on the same problems" but who don't normally work together because of perceived barriers. It's "a forum that removes a lot of those barriers and that can facilitate dialogue."
The first 3D Symposium, in 2003, "was phenomenal," says Kaplan. It was just after a new drug-eluting stent had been released, "and there was a concern about subacute thrombosis." A stent is a metal mesh tube that's inserted in an artery to keep it open, and "drug-eluting" means it slowly releases drugs to reduce the risk of reblockage. This stent was the first of its kind recommended for FDA approval,
but there were worries it might cause small blood clots. "The FDA had filed a letter and then came to the conference," says Kaplan. The discussion culminated in a published paper about developing better post-market surveillance strategies.
Process: That first year, participants also talked about differences between the European and U.S. regulatory environments. In Europe, the approval process for medical devices requires only that a device be proven safe. But in the U.S., both safety and efficacy have to be shown.
"There's a movement afoot called harmonization," to standardize the criteria in Europe and the U.S., says Kaplan. While the 3D discussions weren't
responsible for the movement, they did help to demystify the process.
In fact, demystifying the device development process has been an important result of the 3D sessions and the papers published afterward in leading journals like Circulation and Health Affairs. "Part of the dilemma is that often the clinical community sees device development as a black box," says Kaplan. The 3D papers have helped educate clinicians and the public by describing the device development process, the regulatory hurdles, and other challenges. It "also helps enrich dialogue to regulators and the business community as to how to meet patients' needs quicker," says Kaplan.
Other topics covered have included conflicts of interest and what's known as the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE)—a process meant to facilitate the approval of devices intended for rare conditions. But a post- 3D report, published in Circulation, raised awareness about misuse of the HUD/HDE process to circumvent the normal, long approval pathway. The report may have changed "the way start-up companies are looking at that pathway," says Kaplan. "I don't know how much of that is from the symposium, but it helped educate the community, . . . identified some of the pitfalls, and made sure [the process] is used more appropriately."
A topic being considered for next year's retreat is Institutional Review Boards—committees that review and monitor any biomedical research involving human subjects. The 2006 3D Extravaganza—er, Symposium—is already "sold out," or oversubscribed, as Kaplan puts it.
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