Medtech leaders discuss the hurdles and opportunities on the horizon for medical device companies in the coming year and beyond.

January 1, 2008

6 Min Read
Roundtable Participants

GOVERNMENTAL & LEGAL AFFAIRS

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Tien T. Bui is founder and principal of BioZen Consulting (San Francisco), a firm that assists small life sciences companies in bringing innovative products and technologies to market. Bui has 18 years of work experience in the pharmaceutical and biotechnology industries, where she has been extensively involved in all aspects of drug and technology commercialization.

Prior to starting her own firm, Bui served as a member of the executive team at Monogram Biosciences (formerly Virologic Inc.) as vice president of sales and marketing and vice president of medical affairs, virology and oncology. During her seven years at Monogram, Bui launched three new technologies; started the company's first specialty sales force in HIV; and was in charge of all commercial functions, including payer relations, client services, medical marketing, and clinical affairs and education. Before joining Monogram, Bui served in various commercial, health policy, and strategic product development roles at DuPont and DuPont-Merck Pharmaceuticals from 1990 to 2000.

Bui holds bachelor's degrees in international marketing from San Francisco State University, and in biology from Louisiana State University. She also studied abroad under a 15-month scholarship at the University of Liége, Belgium. Bui currently serves as an advisor for the National Institutes of Health commercial assistance program.

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Mitchell DeKoven is director of reimbursement and market access at IMS Consulting (Falls Church, VA), where he leads teams in a variety of market access, reimbursement, and value development projects, including payer and provider market research, formulary tier research, and strategic reimbursement and pricing assessments. DeKoven was an associate director of reimbursement and market access at ValueMedics Research LLC, which IMS acquired in March 2007. Prior to joining ValueMedics, he was manager of reimbursement services at the United BioSource Corp. center for pricing and reimbursement. Previous to his experience at UBC, DeKoven was the program manager of the Center for Cancer and Blood Disorders at Children's National Medical Center (Washington, DC), a position he held after completing a two-year administrative fellowship with the Johns Hopkins Health System.

DeKoven is chairman of the board of directors of the Lupus Foundation of America's Greater Washington chapter and sits on the editorial advisory boards of Biotechnology Healthcare and the Journal of Commercial Biotechnology. He is a member of the reimbursement editorial advisory council of MX and is a peer reviewer for Formulary and the Journal of Pharmaceutical Marketing and Management. DeKoven earned his MHSA from the University of Michigan School of Public Health and his BA in Spanish from Washington University (St. Louis).

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Ted R. Mannen has more than 25 years' experience in reimbursement and public policy issues affecting device, diagnostics, and drug companies and their industry trade associations. He worked as a lawyer in the U.S. Senate and House of Representatives, and served in senior positions at the Health Industry Manufacturers Association (now AdvaMed), including general counsel and executive vice president for healthcare systems.

Mannen is now a member of the national law firm of Epstein Becker & Green PC (Washington, DC), where he provides regulatory and legislative counsel in one of the largest U.S. healthcare and life sciences legal practices. As a managing director of the firm's consulting affiliate, EBG Advisors Inc., he specializes in reimbursement planning and positioning for the medical device and pharmaceutical industries. Mannen is also managing director of ContentHealth LLC, for which he edits the health policy Web site, www.healthhombre.com.

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Ronald Podraza is an attorney specializing in legal and nonlegal aspects of medical product reimbursement. In his early career he was general counsel for a cardiac pacemaker company and start-up CEO of new product ventures. In 1993 he returned to law school for an advanced degree in healthcare finance (reimbursement). He then led reimbursement development for two medical devices that restored hand and bladder function to paralytics, as CEO of a venture capital-backed start-up. In 1998 he cofounded Reimbursement Principles Inc. (Littleton, CO), a reimbursement consulting firm that serves medical technology innovators.

Podraza holds a JD from Stanford University School of Law and an LLM degree from Georgetown University Law Center.

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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).

Richner has been a leader in policy initiatives in Washington, DC, with the U.S. Congress and the Centers for Medicare and Medicaid Services. She holds 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 of science nursing program.

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Jo Ellen F. Slurzberg is vice president for reimbursement and health policy at Almyra Inc. (Boxborough, MA), a private international medical device holding company for a variety of firms bringing new therapeutic and implantable cardiac and obesity-related products to market. Since joining the company in June 2004, she has been responsible for worldwide strategic reimbursement, health policy, and business development for the portfolio of medical devices and companies supported by the holding company.

Prior to joining Almyra, Slurzberg was part of the executive consulting team at Boston Healthcare Associates (Boston). She served as vice president of consulting, leading the strategic reimbursement practice and consulting to the medical device, in vitro diagnostics, pharmaceutical, and biotechnology industries, as well as to various investment banks and venture capital firms.

Slurzberg began her career in the life sciences industry in 1983 in sales and marketing and has specialized in reimbursement and health policy since 1992. She has experience in both U.S. and EU reimbursement and has a track record of achieving coverage, coding, and payment for innovative products.

In 2006, Slurzberg was elected to serve on the board of directors of the Medical Device Manufacturers Association (MDMA), and she chairs the MDMA reimbursement task force. In 2005, MX magazine profiled her among four U.S. reimbursement experts for the year, and in 2006 she was named to the MX editorial advisory board. She has conducted training programs and authored publications on general reimbursement, and coauthored two Harvard Business School Notes with Harvard professor of business administration Regina E. Herzlinger, PhD. Slurzberg speaks frequently on reimbursement-related business planning and development topics.

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Kuo Bianchini Tong is founder and president of Quorum Consulting Inc. (San Francisco), a company that consults with clients in the pharmaceutical, biotechnology, and medical device manufacturing industries. Tong works with his clients to help them understand how economic, financial, and reimbursement forces can be managed, and how to influence product acceptance and utilization. His consulting engagements focus on strategic planning and implementation in early phases of product development, during clinical evaluation, and following regulatory approval.

Tong is an active member of numerous professional organizations and societies, including the Academy of Managed Care Pharmacy, American Public Health Association, American Society for Blood and Marrow Transplantation, American Society of Clinical Oncology, Infectious Disease Society of America, International Society for Heart and Lung Transplantation, International Society for Pharmacoeconomics and Outcomes Research, and Society for Investigative Dermatology.

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