Medical Device Link.

EDITORIAL ADVISORY BOARD

Throughout 2006, MX announced members of its new editorial advisory board. Members of the board include a variety of experts drawn from industry, government, finance, legal circles, and academic organizations, each with specialized expertise in the business of medical technology. The overall advisory board encompasses 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 additional members of councils that were rolled out in 2006. MX looks forward to the contributions of these editorial advisers, as well as those who have been announced in previous issues.

Finance

Lavinsky

Corey Lavinsky is CEO of Growthink Research Inc. (Los Angeles), a venture capital research firm. Prior to the company's incorporation in January 2003, Lavinsky served as director of research for Growthink Inc., a consultancy that developed business plans for companies looking for capital.

From 1993 to 1999, Lavinsky was an attorney at the law firm Klutho, Cody & Kilo PC (St. Louis), where he was the firm's primary contact for appellate litigation and large-scale research projects. Previously, he served as an assistant law clerk for the Honorable Leonard D. Wexler (U.S. District Court, Eastern District of New York) and the Honorable Charles B. Blackmar (Former Chief Justice of the Missouri Supreme Court).

Lavinsky earned his BA from the State University of New York at Binghamton (1990) and his JD from the University of Missouri School of Law (1993), where he was a member of the Missouri Law Review.

Lavinsky has helped hundreds of entrepreneurs in the capital-raising process and is a frequent speaker at venture capital conferences.

Governmental Affairs and Public Policy

Gottlieb

Scott Gottlieb, MD, was deputy commissioner for medical and scientific affairs at FDA from 2005 to 2007. He left the agency in January 2007 to return to the American Enterprise Institute (AEI; Washington, DC), a think tank where he was previously a resident fellow prior to joining FDA.

Prior to his most recent role at FDA, Gottlieb was a senior adviser to the administrator of the Centers for Medicare and Medicaid Services (CMS), where he worked on payment reforms and on implementation of the new Part D Medicare drug benefit. He also served as director of medical policy development at FDA and as the senior adviser for medical technology to then—FDA Commissioner Mark McClellan, MD, PhD.

Gottlieb is a practicing physician who continued to do clinical medicine throughout the duration of his government service.

During his earlier tenure at AEI, Gottlieb researched FDA and CMS regulatory policies, the development of new medical technology, and political and clinical trends in medicine. Previously he worked as a healthcare analyst for investment bank Alex. Brown & Sons.

Gottlieb received an MD from Mount Sinai School of Medicine (New York City) and completed a residency in internal medicine at the Mount Sinai Medical Center. He holds a BA in economics from Wesleyan University (Middletown, CT).

Kimbell

Jeffrey J. Kimbell, president of Jeffrey J. Kimbell & Associates (Washington, DC), represents clients in the medical technology community seeking legislative remedies for their needs. Kimbell & Associates was founded in 1998 and has since grown to include five full-time lobbyists and policy experts in the field of medical devices, pharmaceuticals, biodefense, and biotechnology. As of the fall of 2005, the firm has 15 hand-selected clients, all in the medical technology field.

The firm's practice focuses on the executive and legislative branches of the U.S. federal government and specializes in providing legislative solutions to a select group of medical technology clients seeking creation, modification, or proper implementation of public law. The firm currently lobbies on behalf of clients with issues before the U.S. Department of Health and Human Services (HHS), the U.S. Department of Commerce, the U.S. Department of Homeland Security, and the U.S. Department of Defense. The firm maintains strong relationships with political appointees and policy teams in cabinet-level departments, agencies, and subagencies. Additionally, Kimbell has lobbied the congressional committees with oversight and budget authority over the departments for more than 10 years, including the House and Senate Appropriations Committees; the House Ways and Means Committee; the House Energy and Commerce Committee; the Senate Finance Committee; and the Senate Committee on Health, Education, Labor, and Pensions.

In January 2001, three years after establishing his firm, Kimbell was named to President George W. Bush's transition team advisory committee for HHS. He was the only consultant to serve on the committee.

Prior to founding Kimbell & Associates, Kimbell served as the first executive director of the Medical Device Manufacturers Association (MDMA). While at MDMA, he directed all Washington policy initiatives on behalf of MDMA's member companies. During his tenure, the association grew from 25 companies to 130, an increase that can be directly attributed to a number of legislative victories, including passage of a landmark bill to overhaul the product approval process at FDA.

In addition to the handling of those matters before the U.S. Congress, Kimbell was responsible for MDMA's interaction with state and foreign governments and federal agencies of jurisdiction on tax and trade matters. In this capacity, he worked very closely with both the Department of Commerce and U.S. Trade Representative. As the principal spokesperson for MDMA, Kimbell handled all communications with the media, the public and private financing communities on Wall Street and related venture capital firms, Congress, the White House, HHS, and FDA.

While at MDMA, in 1996, Kimbell was elected vice president of the National Medical Device Coalition (NMDC), a 10-association grassroots coalition representing 700 companies. NMDC lobbied Congress and the White House for enactment of the FDA reform law. Kimbell orchestrated five senior management fly-ins, allowing 200 senior executives to meet with virtually every member of Congress, 80 Senate offices, and key senior personnel in the White House, the Department of Commerce, the USTR, FDA, and HHS.

Prior to his tenure at MDMA, Kimbell was a personal aide to former Senator Howard H. Baker Jr. (R–TN) and former Secretary of State Lawrence S. Eagleburger in the Washington office of the Tennessee-based law firm Baker, Worthington, Crossley & Stansberry. While at Baker Worthington, Kimbell tracked legislative activity for a host of Fortune 500 clients and helped coordinate events for former U.S. Senate Majority Leader Bill Frist, MD (R–TN); U.S. Senator Lamar Alexander (R–TN); and former Senator Fred Thompson (R–TN).

Kimbell graduated from Southern Methodist University (SMU; Dallas), where he earned a BA in political science. While at SMU, he worked for U.S. Congressman Sam Johnson (R–TX), a member of the House Ways and Means Committee, which has jurisdiction over tax, trade, and a significant portion of Medicare.

Liden

Barry Liden is director of government affairs for Edwards Lifesciences (Irvine, CA), a global leader in products and technologies to treat cardiovascular disease. He is responsible for public policy development and advocacy for the company, focusing on state government relations. Previously he served as director of global communications for Edwards, responsible for the company's external public relations, including media and community relations.

Before joining Edwards in 2002, Liden served for three years as vice president for public affairs at Rogers & Associates, the largest privately owned strategic public relations agency on the West Coast, and for four years as principal at Dallas-based Bustin & Co., an integrated marketing consultancy.

He began his public affairs career in 1990 as the director of government relations for the Los Angeles Area Chamber of Commerce, responsible for transportation and environmental policy development and advocacy for the greater Los Angeles business community. For more than 15 years, Liden has integrated public policy, marketing, public relations, and crisis management practices to provide strategic solutions to his clients' and employers' challenges—experience that he shares weekly with public relations undergraduate students at the University of Southern California as an adjunct faculty member in the Annenberg School of Communications.

Liden has a BS in public administration from the University of Southern California, and a JD from Loyola Law School (Los Angeles).

Northrup

Stephen J. Northrup is senior government relations director for Arent Fox LLP (Washington, DC). With 15 years' experience as a senior Senate committee staffer, a trade association executive, and a federal and state lobbyist, Northrup has an extensive background in health policy.

Prior to joining Arent Fox in December 2006, Northrup served as the health policy director for the U.S. Senate Committee on Health, Education, Labor, and Pensions, chaired by Senator Michael B. Enzi (R–WY). In that role, he helped Enzi write into law 19 healthcare bills in the committee's jurisdiction during the 109th Congress. Northrup was responsible for managing the chairman's agenda and leading staff negotiations on a wide variety of issues, including medical device user fees, postmarket surveillance of drugs and dietary supplements, biodefense preparedness, health insurance reform, electronic medical records, patient safety, autism awareness and research, and the reauthorization of critical laws governing HIV-AIDS treatment and the National Institutes of Health. Northrup also served as Enzi's health policy adviser upon joining his office in January 2003. In this role, Northrup's work included drafting amendments to the Medicare Modernization Act.

Previously, Northrup was the executive director of the Long Term Care Pharmacy Alliance (LTCPA; Washington, DC), formed in 2001 to represent the interests of pharmacies that serve patients in nursing homes and other long-term-care facilities. Northrup coordinated and led LTCPA's federal and state advocacy efforts on Medicare and Medicaid reimbursement for pharmacy services and other government initiatives that affected the profession and business of long-term-care pharmacy.

Prior to joining LTCPA, Northrup served as executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC). As executive director of the 150-member MDMA, Northrup managed all aspects of the association's agenda, including advocacy, public relations, membership services and development, and strategic planning. He played key roles in the industry's interaction with FDA during the agency's implementation of the FDA Modernization Act of 1997, in the development of a new process through which Medicare makes national coverage decisions on new medical procedures and technologies, and in spurring an ongoing congressional inquiry into the effects of healthcare group purchasing organizations on competition in the medical technology marketplace.

Northrup came to MDMA from Loyola University Medical Center, where he held the position of director of government and community relations. Prior to his tenure at Loyola, Northrup was a legislative analyst for the Association of American Medical Colleges (Washington, DC), which represents the nation's medical schools, major teaching hospitals, and medical school faculty societies.

Northrup has led a variety of private-sector coalitions and has served on government advisory committees, including the U.S. Department of Veterans Affairs ad hoc committee on technology transfer and the Medicaid outpatient advisory group to the Illinois Department of Public Aid. Northrup also represented a coalition of health professions school associations on two negotiated rule-making committees convened by the U.S. Department of Education.

Northrup's expertise in strategic communications was honed during his years as a nationally recognized spokesman for the medical device industry. He has testified before Congress, state legislatures, and various federal and state agencies. He has also appeared in segments on ABC's "Good Morning America," CNBC, Bloomberg News, and National Public Radio, and has been quoted in major national newspapers and magazines. Throughout his career, he has given and continues to give speeches and presentations to a variety of audiences, from food and drug lawyers to venture capitalists, and from Main Street businesspeople to Wall Street analysts.

Northrup received a BA from Hamilton College in 1989 and an MPA from George Mason University in 1996.

Legal Affairs

Isbester

A. James Isbester, founder of Isbester & Associates LLP (Berkeley, CA), has been advising and representing clients in intellectual property (IP), antitrust, and related matters since 1987. Although his clients include various traditional businesses, most of his work is on behalf of emerging high-technology and medical device companies.

In 2002, Isbester formed Isbester & Associates in order to pursue patent counseling and nonlitigation resolutions of patent controversies. In 2003, he became a member of the Northern District of California panel of mediators, specializing in intellectual property matters. He now devotes a substantial portion of his time to assisting other lawyers and their clients in reaching settlements.

It is not always possible to avoid litigation, however. In 2006, Isbester won a judgment in the District of Delaware of more than $234 million in a patent dispute relating to cataract equipment. He continues to represent clients in technology litigation in federal courts around the country.

"In medical devices particularly, there is almost always more than one way to accomplish a given goal," Isbester says. "Early identification of the solutions blocked by competitor patents permits the engineering staff to develop alternatives. Late identification subjects the product either to expensive reengineering—which increases the development costs that must be amortized and delays introduction—or exposes the product to avoidable IP licensing fees. Not identifying applicable patents at all exposes the company to past damages and the market dislocation an injunctive can cause."

Isbester recommends that medtech companies seek outside counsel who are willing to team up with employees. "For a well-heeled client, the law firm might do the patent searching required by a new product patent clearance investigation," he says. "In-house engineering staff can easily be trained to do this. Generally speaking, patent lawyers have engineering backgrounds and love to perform the technically oriented tasks that patent law frequently requires. But that does not mean they should or that the client's own engineer employees should not."

Prior to founding Isbester & Associates in 2002, Isbester was a partner with Gibson, Dunn & Crutcher LLP (San Francisco and Palo Alto, CA). During his time with the firm, he represented high-technology, medical device, and other companies in intellectual property disputes, including trials and appeals. He led negotiations of license, development, and similar technology-intensive agreements and also provided intellectual property counsel to underwriters and issuers in public market offerings. Before joining Gibson, Dunn & Crutcher, he was a partner with Townsend and Townsend and Crew LLP (San Francisco).

Isbester says that the various legislative patent reform propositions currently in play have less potential impact for medical device manufacturers than the Supreme Court's current review of the judicially created obviousness standard. "Currently, in order to demonstrate that an idea claimed in a patent application is obvious and therefore should not be allowed—or, if the patent has already been granted by the patent office, should be found invalid by a court—the party challenging the claim must show that there was a motivation to combine elements found in the prior art,"

Isbester says. "The result of the motivation-to-combine requirement is that many incremental steps forward that engineers regard as simply the competent application of the best available tools to a given problem get patented and taken out of the public domain. With luck, the Supreme Court will require that, in order to constitute a patentable invention, the idea must be something more than mere competent engineering."

Isbester is a member of the State Bar of California, all United States district courts in California, and the United States Court of Appeals for both the Federal District and the Ninth District. He has been admitted to practice before the U.S. Patent and Trademark Office since 1991. He is a member of various professional bodies, including the American Intellectual Property Law Association and the IP section of the American Bar Association. He speaks frequently to professional groups regarding patent law and patent licensing matters.

Isbester received a BSE in chemical engineering from Princeton University and an LLB from Osgoode Hall Law School (Toronto).

Singer

Nancy Singer is the general counsel of Lansinoh Laboratories (Alexandria, VA), a company that manufactures medical devices and other products for breastfeeding. Singer also serves as president of Compliance-Alliance LLC, a firm that specializes in professional development for those employed in the drug and medical device industries.

Singer is the founder and former executive director of AdvaMed's Medical Technology Learning Institute, an educational entity within the industry association that provides training on the regulatory requirements of FDA and the Centers for Medicare and Medicaid Services (Baltimore). She also served as AdvaMed's special counsel for FDA compliance and enforcement matters. In this role, she chaired the industry working group that evaluated and suggested reforms to FDA's inspectional process.

Singer later represented the medtech industry on the working group that conceived and validated the procedures for the quality system inspection technique (QSIT). She served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry. For her efforts, she received a Hammer Award from Vice President Al Gore's National Partnership for Reinventing Government. She also received the FDA commissioner's special citation.

Before joining AdvaMed, Singer was vice president and executive director of the Food and Drug Law Institute. Her food and drug career began as an attorney at the U.S. Department of Justice, where she litigated on behalf of FDA. Subsequently, she was a partner at the law firm of Kleinfeld, Kaplan and Becker (Washington, DC).

Singer has a BS from Cornell University and JD and LLM degrees from New York University Law School. She has taught food and drug law at Catholic University Law School and George Washington University Law School. She was also chairperson of the food and drug law section of the Federal Bar Association and is a retired commander in the U.S. Navy Reserve.

Reimbursement

DeKoven

Mitchell DeKoven is associate director for reimbursement and market access at ValueMedics Research LLC (Falls Church, VA). He leads teams in a variety of market access and reimbursement projects, including payer and provider market research, formulary tier research and strategic reimbursement and pricing assessments. He is also instrumental in reimbursement and market access new business development efforts.

Prior to joining ValueMedics, DeKoven held the position of manager for reimbursement services at the United BioSource Corp. Center for Pricing and Reimbursement. Before that, he served as a consultant with CHPS Consulting (now Navigant Consulting). Previous to that experience, he was the program manager of the Center for Cancer and Blood Disorders at Children's National Medical Center (Washington, DC), a position he sought out after completing a two-year administrative fellowship at the Johns Hopkins Health System.

DeKoven has published several articles in leading healthcare journals. He sits on the editorial advisory boards of Biotechnology Healthcare and Specialty Pharma magazines, and is a peer reviewer for Formulary. He earned a BA degree in Spanish from Washington University (St. Louis) and received a master's degree in health services administration from the University of Michigan School of Public Health. DeKoven is currently chairman of the board of directors of the Greater Washington chapter of the Lupus Foundation of America.