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.

With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.