CONTRIBUTORS

Few aspects of the medical world are one-dimensional, and marketing within the healthcare field is no exception. Faced with a diverse—and sometimes skeptical—mix of customers, medical product marketing must extend beyond a catchy jingle or sleek logo if it is to woo its audience. At its pinnacle, medical marketing not only catches the attention of its targeted consumers, but also conveys valuable information and convincing data to support the use of a product. In this issue, MX looks at medtech marketing trends based on the winning submissions in the Medical Marketing Association's 2007 International Awards of Excellence competition.

Market Analysis

In recent years, the market for ophthalmic devices has changed dramatically in light of shifting demographics and the emergence of advanced technologies. Although a fair amount of consolidation has taken place among ophthalmology technology companies in the last half-decade, a number of entrepreneurial firms have surfaced with promising innovations that will keep the specialty vibrant with possibility. In "Evolving Ophthalmology", Patrick Driscoll explores these and other trends in the market for ophthalmic devices, as well as how such trends fit into the context of the broader eye-care market. Driscoll is founder and president of MedMarket Diligence LLC (Foothill Ranch, CA), a source of market intelligence and insights in the medical technology industry. He has 25 years' experience researching, analyzing, and advising within the medical device, biotech, and biopharmaceuticals industries. Driscoll can be reached at 949/859-3401 or via e-mail at [email protected].

Business Planning & Technology Development

Recent events, including the reevaluation of the Taxus and Cypher coronary drug-eluting stents and the recall of the prescription medication Vioxx, have prompted the call for increased scrutiny of the way in which clinical trials are conducted, as well as for an expansion in the number and duration of clinical trials. Thus, thoughtful planning is the key to navigating the complexity of the current clinical trials landscape. Immediately following the successful completion of preclinical testing, sponsors should develop and implement a critical path strategy for their clinical trial phases. In "Clinical Considerations", LaDale K. George outlines the key components of such a strategy. George is a partner in the healthcare and life sciences teams at Foley & Lardner LLP (Chicago) and is the leader of the translational research focus group. He has nearly 15 years of experience providing strategic counseling and legal advice to physician groups, hospitals, governmental healthcare providers, and the drug and medical device development industries on regulatory compliance and business transactions. He can be reached at 312/832-4388 or via e-mail at [email protected].

Governmental & Legal Affairs

In a move that will likely provide a definitive resolution to the issue of federal preemption for medical devices cleared to market via the premarket approval (PMA) path, the Supreme Court announced in June that it would review the case of Riegel v. Medtronic. Federal preemption is a legal concept that provides that federal laws and regulations take precedence over state laws and regulations in the same area. Most federal courts of appeals have decided that a preemption defense is available to manufacturers of PMA devices for most tort claims. Only one, the 11th Circuit, has declined to extend preemption. But until now, the Supreme Court had not agreed to decide whether state claims involving devices approved through the PMA process are preempted. The appeal is scheduled to be heard during the Supreme Court's October 2007 term. In "Preemption for PMA Devices", Caryn M. Silverman provides background on the series of events leading up to this decision—and what it could mean for medical device manufacturers. Silverman is a partner in the law firm of Sedgwick, Detert, Moran & Arnold LLP (New York City). She is an experienced trial and litigation attorney who concentrates her practice on complex civil litigation. She has particular expertise in products liability, with an emphasis on pharmaceutical and medical device litigation. She has served as national and local counsel in pharmaceutical mass tort litigation. She can be reached at 212/422-0202 or via e-mail at [email protected].