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January 23, 2008
By: Christopher Delporte
Editorial Director, Medical Devices
Where did the year go? If you’re like me, you’ve asked that question a lot recently. I’ve heard people say that the older you get, the quicker time seems to pass. Though the notion always seemed a little odd to me, I think I may be changing my mind. It’s déjà vu all over again and here we are, once again, at the start of a new year. For Medical Product Outsourcing, 2008 marks our fifth anniversary. And much as the industry has grown and evolved over the past half decade, so has MPO. We’re looking forward to a new year of possibilities. One of our goals this year—a resolution, if you will—is not just to continue to provide the in-depth news and information on outsourcing topics you’ve come to expect, but to expand our coverage of new technology, business trends, company and executive profiles, and international perspectives. In this issue, MPO takes a new spin on research and development with a detailed look at the growth in outsourcing of clinical research activities (see “Trials and Tribulations” on page 66). And speaking of international perspective, “What Do Medical Device Manufacturers Need to Know About Vietnam?” (page 60) answers its own question as it examines this emerging market as a new medical device manufacturing option in Asia and provides tips and guidance. Also, don’t miss our look at the growth of EMS providers in the medical technology sector and how they’ve taken on the role as full-service manufacturing partners (page 48). In addition, our first issue of the year introduces a new risk management column penned by Marc H. Miller, president of Crimson Life Sciences in Boston, MA. Marc holds a degree in languages and literature from Harvard University and an MBA from the Scottish Business School in Stirling, Scotland. A frequent lecturer and oft-cited expert on risk management issues, Marc has written feature articles for Medical Product Outsourcing and our sister publication Orthopedic Design & Technology in the past, and we look forward to his regular contribution as a columnist. I know you’ll benefit from his expert advice and enjoy his commentary, which always is well written. You can find his inaugural column “Cave Paintings, Black Swans and Standards: Practitioners’ Perspectives on Risk Management” on page 22. MPO also continues to expand the depth of expertise of its Editorial Advisory Board. Since our last issue, the board has increased with nine new members. Though you may not immediately recognize their contribution each month as you would a monthly column, their impact and feedback certainly helps to guide each issue. This group of industry professionals represents many different sectors of medical technology—public and private, industry and academic—and we’re pleased they’ve been generous enough to share their time and experience with us: Robie Ardi, vice president, Lansinoh Laboratories, Inc.; Jennifer Bragg, partner, King & Spalding, LLC; Tara Kambeitz, global marketing manager, Medical Business Unit, Underwriters Laboratories Inc.; Michael Morton, senior director for Corporate Regulatory Affairs, Medtronic, Inc.; Susan Mucha, president, Powell-Mucha Consulting, Inc; Frances Richmond, PhD, professor and director, Regulatory Science Program, University of Southern California; Jan Welch, Office of Compliance, FDA, Center for Devices and Radiological Health; Nikki Willett, vice president of Marketing and Regulatory Products, Pilgrim Software; and Emi Zychlinsky, PhD, vice president, Research and Development, Hitachi Chemical Diagnostics. I look forward to reporting more developments as 2008 rolls forward. There’s much to do before we find ourselves asking the same questions this time next year. Time flies while you’re having fun.
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