Guiding Government

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 in matters of importance to the medtech community 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.

In addition to trade and professional associations that advocate for the interests of medical technology, many individual manufacturers have established governmental affairs departments in order to ensure their voices are heard by legislators. Their actions and advice are helping to shape the future of the industry for all its players.

Throughout 2006, MX is announcing members of its new editorial advisory board. Members of the board will include a variety of experts drawn from industry, government, finance, legal affairs, and academic organizations, each with specialized expertise in the business of medical technology.

The overall advisory board will encompass a series of councils, each dedicated to a separate area and including several experts in the field. In this issue, MX is pleased to present 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. She is responsible for all Medtronic quality, regulatory, and clinical compliance efforts, including overseeing health policy and payment. 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), a forum for FDA and the legal, business, academic, and consumer communities to exchange perspectives on public policy, law, and regulation relating to products subject to FDA jurisdiction. She also serves on the board of the Medical Technology Leadership Forum (MTLF), an educational organization headquartered in Washington, DC, and focused on policymakers, the general public, and the media, regarding critical issues affecting the development and adoption of advanced medical technology. In addition, Alpert serves on the board of Women Business Leaders (WBL), an organization of women leaders in the healthcare sector, and she is president-elect of the Regulatory Affairs Professionals Society.

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. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.

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) and completed her clinical training at Montefiore Medical Center (New York City) and at Children's National Medical Center (Washington, DC).

Thomas A. Connaughton is vice president of legislative affairs for the medical device and supply company 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. We can expect increasingly aggressive attempts to limit coverage for technology-dependent therapies and continuous efforts to reduce reimbursement rates."

Connaughton says he spends the majority of his time working on issues involving coverage, reimbursement, and domestic and international device regulation. "Medtech executives must understand the climate in which they are working, involve themselves in the political process, and help to educate policymakers about the great value that technology brings to patients," he says.

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. He maintained a federal regulatory and legislative practice with an emphasis on healthcare.

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. He also served in the U.S. Army as a captain in military intelligence, after which he practiced law in Indiana before moving to Washington, DC.

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. This is not to say the patent system is perfect, but it's a very good system.

"Undoubtedly any system can be taken advantage of," he adds. "And unfortunately cases in which a few companies are buying up patents and then suing other companies are being overemphasized and creating an incorrect perception that there is a fundamental problem with the overall patent system. This problem could be fixed with simple reforms, such as not granting injunctions to companies that hold patents but have no products based on those patents or any plans to make such products."

Kiani is an inventor on more than 50 patents related to signal processing, sensors, and patient monitoring, including patents for the invention of motion and low-perfusion tolerant pulse oximetry.

In May, Masimo Corp. was honored by the American Electronics Association's Orange County Council at its annual High Tech Awards ceremony. The association recognized the Masimo Rainbow SET Rad-57 pulse CO-oximeter as the innovative product winner in the medical technology category.

Masimo and Kiani have received numerous other awards, including the Society of Critical Care Medicine technology excellence award; the March of Dimes leadership award; Frost & Sullivan's market engineering, quality leadership, and new standard of care awards; the director of the year award from the Forum for Corporate Directors; a 2006 Medical Design Excellence Award; and the Business Journal's 2006 excellence in entrepreneurship award. Masimo was also listed seventh among the world's top medical device companies on the ipIQ 2006 Patent Scorecard for corporate innovation.

Prior to founding Masimo, Kiani served as regional technical manager for Anthem Electronics, as well as field applications engineer for Bell Industries, which distributed advanced semiconductor components. Kiani was also a product engineer at Unisys.

Kiani also serves on the boards of the Orange County section of the March of Dimes, the Medical Device Manufacturers Association (MDMA), and Saba, a publicly traded software company focused on human capital development and management solutions.

Over the past few years, Kiani has been actively involved in congressional investigations into the practices of healthcare group purchasing organizations (GPOs). MDMA and Masimo have been very engaged on this issue, given the critical importance it has on both 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."

Another public policy issue currently facing the medical device industry is the potential reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) as MDUFMA 2. Discussions on the topic continue at a time when FDA still lacks a permanent commissioner. "On a macro level, there is no accountability when there is no leadership," Kiani says. "And undoubtedly, the lack of leadership has hurt the prospects of positive results coming out of MDUFMA. Hopefully this issue will be addressed shortly and all parties can move forward to develop policies that ensure that patients have timely access to safe and effective products."

Kiani holds bachelor's and master's degrees, both 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). He is also a member of the company's North American operating committee, the executive group responsible for Roche's commercial strategy formulation and implementation in the United States and Canada.

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. He is a recognized leader in the U.S. diagnostics industry, chairing numerous industrywide initiatives to ensure patient access to safe and effective new diagnostics. He has been involved in efforts to reform FDA's guidance development processes, to establish the FDA device user-fee program, and to advocate delay in the implementation of Medicare competitive bidding.

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. In the reimbursement arena, Roche has set the standard for successfully advocating the need for technology-sustaining reimbursement policies. Recent successes include doubling the CMS national rate of reimbursement for HIV viral load tests and proBNP, a novel marker for congestive heart failure.

Naples holds a bachelor's degree in medical technology from Youngstown State University. Before joining Roche, he managed Southwest Florida Blood Bank (Tampa, FL) and served as a consumer safety officer for the FDA Center for Biologics Evaluation and Research.

Robert H. O'Holla is vice president of regulatory affairs for the medical devices and diagnostics group at Johnson & Johnson Inc. (New Brunswick, NJ). He began his career in regulatory affairs in 1975 after spending several years in both medical device and drug development.

During his career, O'Holla has held both regulatory and quality assurance positions with manufacturers of medical equipment, implants, and sterile disposables. O'Holla is active with industry association AdvaMed in the areas of product approval and FDA legislation, and the group recently honored him as an AdvaMed Achiever in recognition of his contributions to the work of the association and on behalf of the industry.

"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. "Besides being reactive to proposals, we have a responsibility to identify where problems exist and propose solutions to our policymakers."

Currently, the medical device industry is negotiating the terms of the renewal of MDUFMA. "Ensuring that the Center for Devices and Radiological Health (CDRH) has enough resources to do its job in an efficient and responsible manner is an important priority," O'Holla says.

"Postmarket issues for technology will also be a high priority for both industry and FDA," he adds. "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."

In 2002, O'Holla was awarded the Richard E. Greco Award, the highest honor bestowed by the Regulatory Affairs Professionals Society (RAPS; Rockville, MD). The award recognizes leaders who have made significant contributions to the regulatory affairs profession and to RAPS, and who show personal involvement and commitment in their personal lives. O'Holla is currently chairman of RAPS and a member of the Food and Drug Law Institute's medical devices committee.

O'Holla 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, Richner served as vice president for global government affairs with Boston Scientific Corp. (Natick, MA). Following her move to the company in August 1997, Richner built a global reimbursement and outcomes strategic process for new and existing less-invasive medical technologies for Boston Scientific's product platforms. In this role, she was actively engaged in national and international policy and legislative arenas as an advocate for the benefits of innovative medical technology, FDA, regulatory, international trade, and payment issues.

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 (CMS). She served a four-year term as the first industry representative to the executive committee of the Medicare Coverage Advisory Committee, a role in which she contributed to the development of national coverage and committee process guidelines.

"The additional data needed to answer CMS's questions related to safety are providing enormous operational challenges for medical device companies," she says. "More flexibility and honesty about the mechanisms to control costs need to be established. And this needs to be more comprehensive to include costs included in the delivery of innovation, and not simply the innovation itself.

"The most important role for medtech company 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 adds. "Medical innovation drives efficiencies and changes ahead of the bricks and mortar of delivery care systems. Targeting the engine of healthcare—medical inventions and treatments—to control costs is a profound mistake and will only serve to slow progression of treatment of disease."

Richner has been a frequent contributor on policy panels on healthcare issues related to the technology industry, including an Institute of Medicine's special committee on cost-effectiveness and postmarket surveillance in 2005.

This past spring, Richner was appointed to the dean's advisory board of the University of Michigan's School for Public Health, as well as to the college of fellows of the American Institute of Medical and Biological Engineers. These appointments recognize her contribution to policy and advocacy for medical technology and innovation.

Prior to joining Boston Scientific, Richner was a director of outcomes research and pharmacoeconomics at GlaxoSmithKline in both London and Philadelphia, a role in which she focused primarily on global pricing and economic issues for cardiopulmonary and diabetic drugs in development.

Richner is a member of the Global Health Policy Group, a consortium of leaders of health economics groups in the pharmaceutical and device industry; a former board member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR); founder of the U.S. medical device council of ISPOR; and a member of the University of Michigan Ross Business School's healthcare life sciences corporate advisory board.

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. Before her career in health economics and policy, she was a practicing dialysis and transplant nurse for 13 years at the University of Michigan Hospital and Northern Michigan Hospital.

Peter B. Slone is vice president of government affairs at Medtronic Inc. (Minneapolis). Operating out of Washington, DC, Slone is responsible for the development and execution of the company's federal public policy agenda, and he provides strategic guidance on state and global policy matters as well. It is his office's responsibility to advance Medtronic's mission and facilitate the work of the business units in new product development, regulatory approval, appropriate reimbursement, and enhanced global market access and competitiveness.

"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, who joined Medtronic in 2001, oversees a comprehensive outreach program that seeks to bring hospital, physician, patient advocacy group, and other key stakeholder interests into working collaborations around shared policy interests. In addition, Slone works with U.S. government agencies and the White House to advance industry interests in markets outside of the United States. He cochairs AdvaMed's trade advocacy working group.

Slone played a prominent role in industry advocacy efforts surrounding adoption of device user fees in the Medical Device User Fee and Modernization Act of 2002, as well as key provisions of the 2003 Medicare reform legislation affecting medical technology and patient access. He has also been at the forefront of industry efforts on international matters including Indian tariffs and China and Japan pricing issues.

Other recent policy engagements include postmarket product performance communications, initiatives designed to better align hospital and physician incentives around improved clinical outcomes and efficiencies, and broader efforts to enhance access to critical therapies for underpenetrated patient populations. Slone has also led the company's involvement in coalition efforts to enhance the business climate for innovation, product development, and marketing on matters such as medical liability reform, tax reform, and promotion of free trade.

Prior to joining Medtronic, Slone held the position of managing director in the government relations practice of BKSH & Associates, where he managed a diverse client portfolio. He led numerous health policy engagements, including work on the Biomaterials Access Assurance Act on behalf of AdvaMed (then called the Health Industry Manufacturers Association).

Slone holds a bachelor's degree from Georgetown University's School of Foreign Service and a master's in business administration from the University of North Carolina at Chapel Hill. His MBA program brought him into working collaborations with leading businesspeople in Europe, Latin America, and the Asia Pacific regions.

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

He is a past chairman of the Medical Device Manufacturers Association (MDMA; Washington, DC), a national trade association for the U.S. medical device industry. 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.

"New product development is my main focus," he says. "I call it 'paving the road to the future.' The diagnostics industry is starting to get the attention it deserves. A diagnostic assay's ability to determine how to match drugs with patients who will benefit assists doctors in making better decisions and will help to manage care and costs. This convergence is happening now."

Touhey's initiation to public policy issues came soon after he became an MDMA board member. He represented MDMA and its member companies in the negotiations with Congress and FDA that resulted in enactment of the FDA Modernization Act of 1997. Since then, he has also served as a member of the FDA-Industry Grass Roots Task Force. He has also been heavily involved in monitoring FDA's implementation of the Medical Device User Fee and Modernization Act of 2002.

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

Centocor sold its cancer diagnostics business to Fujirebio in November 1998, and Touhey moved to Fujirebio at the time of the acquisition. He first served as vice president of operations, and then as senior vice president, before being promoted to president and COO in October 2003.

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

MX looks forward to the contributions of these editorial advisers and will continue to announce members of additional councils throughout 2006. 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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