Few companies have dominated a clinical space for as long and as thoroughly as Medtronic in spine surgery. Once a kind of clinical backwater of orthopedics, spine has become one of the fast-growing of all medical technology sectors, and MSD has played a leadership role-not just in developing new technology, but, perhaps even more importantly, in helping to establish spine surgery as a major therapeutic area and commercial market. As spine, and MSD along with it, has exploded, the company risks becoming a victim of its own success. With clinical philosophies and approaches shifting, technology advancing rapidly, and a host of competitors large and small all clamoring for piece of the pie, the challenge for MSD becomes clear: how to maintain its leadership in a market whose success it did so much to foster.

Analysts watching the progress of Stryker's OP-1, the first orthobiologic device to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended the product for European approval on January 3. But three weeks later, FDA sent Stryker a not-approvable letter. As it turned out, however, the OP-1 news, coincident with the company's announcement of strong financial results for 2000, barely put a dent in its stock price.

While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.