CONTRIBUTORS
In this issue, MX showcases people and technologies that are driving excellence in the medical device industry. In this year's Medical Design Excellence Awards (MDEA) competition, nearly three dozen winning products were recognized at a ceremony held in New York City. In MX's annual report on the MDEA competition (page 56), expert suppliers are also named for their contributions to the award-winning products.
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| Slone |
Also, in this issue's cover story, MX profiles medical device executives who are making a difference in their companies, industry, and the future of healthcare (page 26). From orchestrating industry-altering mergers to developing technologies that will revolutionize certain medical treatments, these company leaders have made significant contributions in the past year.
Industry Associations
Over the past 30 years, few industries have fueled as many medical breakthroughs as the venture capital industry. In order to support venture firms and medical device start-ups during the complex regulatory and reimbursement processes, the National Venture Capital Association (NVCA; Arlington, VA) Medical Industry Group identifies and prioritizes key health policy issues that affect healthcare innovation and investment. Lately, two significant issues have ascended to the top of the group's priority list: the need to establish a clearer path to reimbursement for innovative medical devices, and the need for patent reform that protects innovative technologies. In "Investing in Medtech's Future" (page 22), Kelly Slone outlines NVCA's concerns and actions in these crucial areas. Slone is director of federal life science policy for NVCA, a membership-based organization whose members consist of venture capital firms that manage pools of risk equity capital designated to be invested in high-growth companies. Slone can be reached at 703/524-2549 or via e-mail at kslone@nvca.org.
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| Dunn |
Business Planning & Technology Development
Contract manufacturers have certainly benefited from the growth of the medical device industry. However, growth of the outsourced medical manufacturing segment is outpacing that of the device industry as a whole, indicating a trend toward the increased use of outsourcing. In "The Changing Shape of Medtech Outsourcing" (page 38), Ben Dunn examines the current shape of the medical device contract manufacturing sector and how changes in this sector could affect the way medtech companies do business. Dunn is managing director of specialty investment banking firm Covington Associates (Boston). Since joining Covington Associates in 1996, Dunn has orchestrated, negotiated, structured, and valued more than 50 transactions for both public and private companies. Dunn's area of specialty is advising medical technology and healthcare services firms, and he has successfully completed deals with companies including Boston Scientific, Cerner, GE Healthcare, and Siemens. Dunn is a frequent speaker at healthcare conferences and the author of numerous articles, including a recently published white paper, A Strategic Review of Outsourced Manufacturing for Medical Devices. Dunn can be reached at 617/314-3950 or via e-mail at ben@covllc.com.
Information Technologies
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| Gram |
In launching an initiative designed to enhance postmarket monitoring of medical devices, FDA's Center for Devices and Radiological Health (CDRH) has begun reevaluating the systems through which it receives and processes data from consumers, healthcare facilities, and medical device manufacturers. In doing so, the agency has identified the medical device reporting system as an area where improvement is needed. In "The Road to Electronic Medical Device Reporting" (page 66), Michael Gram examines the agency's current move toward electronic reporting and the implications for medical device manufacturers. Gram is a business development manager focused on the medical device industry for Maxiom Group (Waltham, MA), a business and IT consulting firm that focuses exclusively on the medical device, biopharma, and related industries. He has more than 30 years of experience in managing technology-based businesses. His background includes design and manufacturing of medical telemetry systems and providing business and systems consulting to a variety of medical device and biotech companies. Gram can be reached at 781/250-4900 or via e-mail at mgram@maxiomgroup.com.
