Medical device executives know full well that an innovative concept is only the first of many steps in bringing a successful product to market. And every inch of the way, manufacturers must tread carefully to avoid potential technological, legal, or regulatory pitfalls. In this issue, MX explores multiple dimensions of the medtech product life cycle, from the earliest stages of device design to the eventual development of marketing and compliance plans surrounding the product.
Medical device marketers have long counted on the lower profile of the device industry to enable them to avoid the most onerous of restrictions targeted at drug marketing. However, what happens to drugs can easily migrate to devices. Thus, medical device marketers should keep a wary eye on new congressional proposals that would give FDA sweeping powers to regulate the marketing of approved drugs. In "New Boundaries for Medtech Marketing?", John F. Kamp gives an overview of the pending legislation and its implications for drug and device manufacturers alike. Kamp serves as executive director of the Coalition for Health- care Communication (New York City), a trade association that represents the healthcare marketing industry in Washington, DC. He is also of counsel to the law firm of Wiley Rein LLP (Washington, DC). On June 6, Kamp will provide an update on the state of marketing legislation during his presentation, "Review of the Washington Scene: Politics, Policy, and Public Perception," at the Medical Marketing Association's annual conference, which is being held in San Francisco. Kamp can be reached at 202/719-7216 or via e-mail at firstname.lastname@example.org.
Governmental & Legal Affairs
The costs, risks, and delays of conventional litigation have driven product claims to a new battlefield: the mediation table. In "The New Litigation", Brooks Magratten discusses how medical device manufacturers with the proper tools and the proper mind-set can use mediation to resolve a medical device product liability dispute on favorable terms. Magratten is a partner in the law firm of Vetter & White (Providence, RI), where he defends pharmaceutical and medical device manufacturers as a trial lawyer and mediates cases. Magratten is also a member of MX's editorial advisory board council on legal affairs. He can be reached at 401/421-3060 or via e-mail at email@example.com.
Attorneys of the plaintiffs' bar are using increasingly creative tactics in developing and prosecuting medtech product liability actions. In "Trends in Medtech Product Liability Litigation", Victoria Davis Lockard discusses how medtech companies can anticipate such strategies and be ready for action long before the first suit is filed. Lockard is a partner in the law firm of Alston & Bird LLP (Atlanta), where her practice focuses on product liability litigation. She can be reached at 404/881-7786 or via e-mail at firstname.lastname@example.org.
In light of ongoing federal and state investigations and prosecutions, U.S. medical device companies have become especially attuned to the legal and ethical risks involved in their relationships with healthcare professionals. However, such risks can vary widely according to the laws and enforcement environments in different countries. In "Medtech Compliance Goes Global", Paul Silver, Rosemary E. Weghorst, Scott Willoughby, John Bentivoglio, and Nancy Singer discuss how manufacturers can assess their companies' compliance plans on a global scale. Silver is a managing director and global market leader of the pharmaceutical and medical devices practice for Huron Consulting Group (Chicago) and can be reached at 404/419-2302 or via e-mail at email@example.com. Weghorst is a manager in the pharmaceutical and medical devices practice for Huron Consulting Group and can be reached at 859/581-2211 or via e-mail at firstname.lastname@example.org. Willoughby is a managing director at Huron Consulting Group and can be reached at 202/585-6850 or via e-mail at email@example.com. Bentivoglio is a partner in the law firm of King & Spalding LLP (Washington, DC) and can be reached at 202/626-5591 or via e-mail at firstname.lastname@example.org. Singer is president of Compliance-Alliance LLC (Arlington, VA), and can be reached at 703/525-4159 or via e-mail at email@example.com. Huron Consulting Group plans to present the compendium on which this article was based in a CD-Rom format. It will also be available at www.huronconsultinggroup.com.
Medical device companies are responding to growing market pressures and an increasingly crowded competitive landscape by leveraging new and innovative information technologies. In this issue's annual installment of the IT Showcase, Tim Gee examines the changes that have occurred in the healthcare IT market over the past year and looks to new trends on the horizon. Gee is the principal of Medical Connectivity Consulting (Beaverton, OR), a firm that specializes in the application of technology and process reengineering for hospitals and medical product manufacturers. For more than two decades, he has focused on hospital connectivity, creating products to automate work flow for cardiology, the emergency department, radiology, and most patient-care areas. Gee is a member of the Healthcare Information and Management Systems Society (Chicago) work group on medical device security, as well as a member of MX's editorial advisory board council on information technologies. Gee can be reached at 503/481-2370 or via e-mail at firstname.lastname@example.org. For more information, visit www.medicalconnectivity.com.