Guiding Government 4036

Originally Published MX July/August 2006

EDITORIAL ADVISORY BOARD

Newly appointed members of the MX editorial advisory board discuss their efforts to educate decision makers and influence public policy on behalf of the medtech industry.

In the heavily regulated medical device arena, access to Congress and the education of its members have never been more critical than they are today. From reimbursement rates and user fees to patent submissions and FDA communications, regulatory requirements guide the actions of medical device companies in every stage of product development and commercialization.

Throughout 2006, MX is announcing members of its new editorial advisory board. In this issue, MX presents the newly appointed members of the advisory council on governmental affairs and public policy.

Susan Alpert, PhD, MD, is senior vice president and chief quality and regulatory officer at Medtronic Inc. (Minneapolis), a position she has held since 2005. Alpert joined Medtronic in July 2003 as vice president for regulatory affairs and compliance from C. R. Bard Inc., where she had been vice president of regulatory sciences.

Alpert is on the board of the Food and Drug Law Institute (FDLI), and she also serves on the board of the Medical Technology Leadership Forum. In addition, Alpert serves on the board of Women Business Leaders, and she is president-elect of the Regulatory Affairs Professionals Society (RAPS).

Before joining Bard, Alpert served at FDA, where she held a variety of positions in the centers dealing with drugs, devices and radiological health, and foods, including six years as director of the Office of Device Evaluation.

Alpert completed her undergraduate degree at Barnard College, Columbia University, and holds an MS and PhD in biomedical sciences from New York University. She received her MD from the University of Miami (Florida).

Thomas A. Connaughton is vice president of legislative affairs for Cook Group Inc. (Bloomington, IN), serving in the firm's Washington, DC, office. Prior to joining Cook in 2003, he served for three years as president and CEO of the American Association for Homecare.

"The most pressing issues facing our industry right now arise from attempts by the government to reduce healthcare spending for medical technology, which could deny patients the benefit of cutting-edge devices," Connaughton says. "Healthcare expenditures will grow at an increasingly dramatic rate as baby boomers become eligible for Medicare, and policymakers will reach for every tool available to reduce that rate of growth."

Connaughton began his career in public policy in 1974 when he went to work for Senator Birch Bayh. He first acted as counsel to Senator Bayh and the committees on which he served and later served as Bayh's chief of staff in 1979 and 1980.

From 1981 to 1998, Connaughton was managing partner of Bayh, Connaughton, and Stewart, a law firm that he founded in conjunction with Bayh and several other attorneys.

Connaughton received a BA from Stanford University, an MA in American history from Indiana University, and a JD from the University of Michigan Law School.

Joe E. Kiani is founder, chief executive officer, and chairman of the board of Masimo Corp. (Irvine, CA). He has held his positions since Masimo's inception in 1989.

Over the years, Kiani and Masimo have been heavily involved in patent litigation. With possible passage of the Patent Reform Act looming, Kiani says drastic change to the U.S. patent system could harm innovative companies and the U.S. economy. "I believe our patent system as it stands today is very good," he says. "It protects inventors and levels the playing field between giant medtech firms and smaller companies with innovative approaches."

Over the past few years, Kiani has been actively involved in congressional investigations into the practices of healthcare group purchasing organizations (GPOs). "The Medical Device Manufacturers Association (MDMA) and Masimo have been very engaged on this issue, given the critical importance it has on the quality and cost of healthcare in this country," he says. "The Senate understands there is a flaw within the GPO system and that the form of funding for the GPOs is an invitation for corruption and ultimately a weak healthcare system. Unfortunately, it's election time, which means that it's unlikely anything will happen this year."

Kiani holds bachelor's and master's degrees in electrical engineering from San Diego State University.

Richard J. Naples is vice president for regulatory submissions, reimbursement, and government affairs at Roche Diagnostics (Indianapolis).

Naples has more than 30 years' experience in technology policy issues. With experience as a lab manager, an FDA scientific reviewer, and a healthcare executive for one of the world's leading developers of diagnostic technology, Naples brings a unique perspective to the arena of regulated healthcare.

At Roche, Naples has built a strategic approach to premarketing that provides "one-stop shopping" for FDA regulatory submissions, reimbursement affairs, and government relations. His regulatory team has been responsible for more than 200 successful FDA premarket submissions and has consistently achieved review times up to 50% faster than the industry average.

Naples holds a bachelor's degree in medical technology from Youngstown State University.

Robert H. O'Holla is vice president of regulatory affairs for the medical devices and diagnostics group at Johnson & Johnson Inc. (New Brunswick, NJ).

"Medtech executives have a responsibility to provide legislators, regulators, and the healthcare community with realistic assessments of the effects that any proposed legislation or regulatory policy will have on the availability of new treatments and technologies," O'Holla says.

"Postmarket issues for technology will also be a high priority for both industry and FDA," he adds. "The Center for Devices and Radiological Health (CDRH) has a wide variety of postmarket authorities given to it under the Safe Medical Devices Act of 1990. Before any new authorities are added to the list, I would expect CDRH and industry to evaluate how the existing authorities can be utilized more effectively."

O'Holla is currently chairman of RAPS and a member of FDLI's medical devices committee. He holds a bachelor's degree in biology from Upsala College and an MBA in general management from Fairleigh Dickinson University.

Randel E. Richner is founder and president of reimbursement consulting firm Neocure Group LLC (Newton, MA). Prior to launching Neocure, she served as vice president for global government affairs with Boston Scientific Corp. (Natick, MA).

According to Richner, the most important public policy issue currently facing the medical device industry is the risk of overregulation and burdensome legislation as a reaction to technology safety and risk issues. "Overregulation is a true threat right now," she says. "There will be a number of attempts to introduce legislation on the international, national, and state levels to impose additional requirements to monitor the safety of drugs and devices as a reaction to the safety issues being raised in the press."

Richner has been a leader in policy initiatives in Washington, DC, with the U.S. Congress, and the Centers for Medicare and Medicaid Services.

"The most important role for medtech executives when it comes to influencing the shape of future legislation and government policy is to continue to stress, advocate, and articulate the benefits and value of medical innovation as the solution to escalating costs and improvement in the overall health of the individual and economy," she says.

Richner has a master's degree in public health policy and administration from the University of Michigan, where she was also a magna cum laude graduate of the bachelor's in science nursing program.

Peter B. Slone is vice president of government affairs at Medtronic Inc. (Minneapolis).

"Our most important issue right now is the draft inpatient rule," Slone says. "It will be finalized around August 1 and could have profound impacts as payment in the inpatient setting moves to cost-based weight, severity adjustments are introduced, and issues attendant to charge compression and hospital cost reporting are considered. There is extensive legislative interest as well."

Slone cochairs AdvaMed's trade advocacy working group. He played a prominent role in industry advocacy efforts surrounding adoption of device user fees in the Medical Device User Fee and Moderni-zation Act of 2002, as well as key provisions of the 2003 Med-icare reform legislation affecting medical technology and patient access.

Slone holds a bachelor's degree from Georgetown University's School of Foreign Service and an MBA from the University of North Carolina at Chapel Hill.

Paul Touhey is president and COO of Fujirebio Diagnostics Inc. (Malvern, PA).

He is a past chairman of MDMA. A member of the MDMA board since 1996, he served an extended three-year term as chair of the association from June 2000 until June 2003. In 2003, Touhey was honored with the MDMA Founder's Award.

Touhey has worked in the medical device field for 27 years. He began his career working with Johnson & Johnson Inc. from 1976 through 1985. From 1985 through 1998 he worked for Centocor Inc. as an executive in the company's cancer diagnostics business.

Touhey received his bachelor's degree in political science from Temple University (Philadelphia) in 1978. He also completed the executive management program at Cornell University in 1992.

In the September/October issue, MX will present its advisory board members in the areas of corporate governance and legal affairs. To nominate medtech industry experts in these or other fields, contact MX editor in chief Steve Halasey at 310/445-4274 or via e-mail at [email protected].

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