Medical Device Daily Washington Editor

One of the nice things about running a large association populated by engaged members is that you can get a lot of people together at one time and, with a program focused on the best new medical technologies, hold their very close attention.

The Advanced Medical Technology Association (AdvaMed; Washington) intends to do precisely that next week with AdvaMed 2007: The Med-Tech Conference, an inaugural effort.

AdvaMed reports more than 800 registered for the event, Monday through Friday next week, to be held at the Ronald Reagan Building and International Trade Center in the nation’s capital.

As it turns out, the conference will run concurrently with a meeting of the Global Harmonization Task Force, an effort to forge greater alignment of device regulations among nations, which is scheduled for Wednesday and Thursday of next week.

Kenneth Mendez, AdvaMed’s chief administrative officer, told Medical Device Daily that the brainstorming behind the session gave planners “more than double the available slots, and the planning committee pared it down to what they thought was the most cutting edge for our audience.”

“We’re really excited about our speakers,” Mendez said, adding that the list includes Senator Norm Coleman (R-Minnesota), who will talk at the plenary session, as well as Dr. Li Hongshan, the director general of the Ministry of Health in the People’s Republic of China, who will participate in a discussion of that nation’s medical device market, of particular current interest, given that country’s recent headline-making troubles.

The new administrator at the Centers for Medicare & Medicaid Services, Kerry Weems, also will appear, as will Secretary of Commerce Carlos Gutierrez.

The response from industry has been tremendous, he said, and that “we have more than 800 registered so far, from 35 states and 25 countries. Never before have we brought industry together in one place on this kind of scale,” Mendez said.

Among the sessions that dot the agenda for Monday is one that covers antitrust fraud and abuse in medical device pricing. Chaired by Randy Smith, a senior partner at the DC law firm of Crowell & Moring, this session will examine some of the price-fixing cases that have arisen recently, including those that involved bundled products.

Panelists Barbara Ryland, also of Crowell and Moring, and Sheri Edison, VP and general counsel of Hill-Rom (Batesville, Indiana), a maker of hospital products, will review recent case law as well as parallel prosecution by federal and state authorities.

One of the sessions, taking place on Tuesday, will examine “the current and future landscape of cardiovascular medical technology,” and will be moderated by Donald Baim, MD, formerly of Brigham and Women’s Hospital (Boston) and now the chief medical officer at Boston Scientific (Natick, Massachusetts). The panelists will include Laurence Epstein, MD, chief of cardiac arrhythmia service at Brigham, and Stephen Ramee, MD, chief of interventional cardiology at the Ochsner Heart and Vascular Institute (New Orleans).

This panel will discuss unmet needs in cardiology as well as some of the technologies that look most promising to serve in these areas. The panel, which also includes Ted Feldman, MD, director of the cardiac catheterization lab at Evanston Northwestern Hospital (Evanston, Illinois), will also examine some of the regulatory and reimbursement hurdles faced by companies.

Getting through FDA is one thing, but getting paid is quite another matter, as the panelists for another Tuesday session will attest.

Gregory de Lissovoy, MD, VP for health technology at United Biosource (Bethesda, Maryland), will chair a panel that will take up the topic of evidence development paradigms used by payers to compare treatments. Panelists Elise Berliner, Phd, of the Agency for Healthcare Research and Quality and John Bridges, an assistant professor of healthcare economics at the Bloomberg School of Public Health at Johns Hopkins University (Baltimore), will discuss the role of randomized, controlled clinical trials in evidence development along with two other panelists.

One of the sessions taking place Wednesday will address how to finance device development.

James McGrath, president of Geneva Acquisitions (Boston), which went public earlier this year, will moderate a panel that will take up the question of which forms of financing are best suited to a company. Among the financing models they will discuss are special-purpose acquisitions (SPACs) and the London AIM, which is a trade board functioning under the auspices of the London Stock Exchange with less stringent financial requirements than companies that trade on the main board.

Panelists Ewan Phillips, managing director of Deltex Medical (West Sussex, UK), a manufacturer of medical monitors, and Charles Mather, managing director of the equity capital markets group at the Jefferies Group (New York), are also on the panel, which will also examine hedge fund investment and strategic partnering for device firms.

Stem cells and other cellular therapies will often be merged with devices and diagnostics as the 21st century rolls forward, and a panel of four chaired by Lydia Villa-Komaroff, PhD, President of Cytonome (Boston), will take up a Tuesday review of emerging opportunities for devices in these advanced therapeutic modes.

Paul LaViolette, COO of Boston Scientific (Natick, Massachusetts) and David Perez, President of Gambro (Lakewood, Colorado), maker of therapeutic blood products, are two of the four panelists who will discuss the therapeutic areas of greatest interest and the devices they will most likely be partnered with. Among the diseases are heart disease, diabetes, renal disorders and neurological diseases.

The conference includes a CEO roundtable session on Tuesday and will include industry names such as Bill Hawkins of Medtronic (Minneapolis), Edward Ludwig of Becton Dickinson (Franklin Lakes, New Jersey), who also chairs the board of directors at AdvaMed, and Michael Mussalem of Edwards LifeSciences (Irvine, California).

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