Contributors 4029

Originally Published MX July/August 2006

CONTRIBUTORS

Achieving excellence in the medical device industry requires not only high-quality products, but also high-quality people. In this issue, MX showcases both.

In its annual report on the Medical Design Excellence Awards (MDEA) competition, MX recognizes the achievements of medical product manufacturers and the many people behind the scenes who are responsible for the groundbreaking innovations that are changing the face of healthcare. As always, the competition's panel of jurors is integral to the program's success.

Also in this issue, MX profiles medtech executives who are involved in notable activities on behalf of their own companies and the medical device industry as a whole. Their achievements are helping to shape the future of healthcare in the United States and throughout the world.

Industry Associations

Despite the rapid technological innovation that has marked the healthcare industry in recent years, such advances have not been consistently accompanied by the greater use of standards, checks and balances, and redundancies that translate into increased patient safety. To address this deficiency, collaboration among stakeholders will be key in formulating procedures to better address postmarket surveillance of medical devices. In "Failing to Succeed", Yadin B. David outlines a resolution recently passed by the American College of Clinical Engineering's Healthcare Technology Foundation (AHTF) that calls on the medtech industry, regulatory agencies, and leaders from the end-user and consumer communities to identify a framework for enhanced cooperation among their diverse groups when evaluating adverse medical and surgical events. David is president of AHTF and director of the biomedical engineering department at Texas Children's Hospital (Houston). He can be reached by phone at 832/824-1810 or via e-mail at [email protected], and interested parties can learn more about AHTF by visiting the foundation's Web site at www.acce-htf.org.

Governmental & Legal Affairs

Patent reform in the United States is coming—it's just a question of when and in what form. Although changes such as those included in the Patent Reform Act will have an impact across industries, certain elements of the legislation present an opportunity for medical technology entities to improve strategic planning and manage business risks throughout the lengthy product commercialization process. In "The Changing Patent Landscape", Jonathan R. Sick offers a high-level introduction to the features of current patent-reform legislation. Sick is a shareholder at the law firm of McAndrews, Held & Malloy (Chicago), where he counsels and assists clients on a variety of intellectual property matters. He can be reached by phone at 312/775-8000 or via e-mail at [email protected].

The medical device industry is no stranger to antitrust litigation. In an industry whose players include many dominant firms, enforcement of antitrust laws is vital to discouraging anticompetitive practices that can stifle innovation and competition in the market, delay medical and technological progress, and ultimately harm the patients who rely on the devices. In "Protecting Competition", David A. Balto explores various exclusionary contracting practices that raise antitrust concerns and their implications for the medtech industry. Balto is a partner at Robins, Kaplan, Miller & Ciresi LLP (Washington, DC) and former policy director for the Federal Trade Commission. He has practiced antitrust law for more than 20 years, both with the government and in private practice. Balto counsels a variety of healthcare companies, including medical device manufacturers, pharmaceutical manufacturers, specialty pharmaceutical distributors, healthcare systems, and pharmacy chains. His areas of counseling include FDA regulation, strategic alliances, distribution issues, mergers, and joint ventures. Balto can be reached by phone at 202/736-2637 or via e-mail at [email protected].

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