Medtronic is the acknowledged leader in one of the hottest device sectors-neurostimulation-but even this giant struggles with problems of limited market penetration. So Medtronic is bringing a new approach to this area: an aggressive clinical trials strategy to differentiate its products and drive physician adoption. Who better to run the business than a clinical trials expert? Richard Kuntz talks about future neuro opportunities and the current challenges facing device clinical trials.

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.

It is not uncommon for a new medical device to fail to initially live up to projected sales expectations. Early disappointing product sales can produce a hole that a company can spend a long time trying to dig its way out of, having to battle a declining stock price, decreased investor confidence, lower company valuations, and diminished access to capital. The end result may be that both the product and the company are never able to fully recover from the early set-back. Many initial disappointing product roll-outs can be attributed to problems that commonly confront device companies. Product companies have adopted successful strategies to anticipate and overcome many of these issues, and thereby increase the chances of a new product coming strong out-of-the blocks.

MiniMed's growth rate has been slipping down through the teens for some time: the introduction of long-acting basal insulin is slowing growth of its core insulin pump business, and development of a continuous glucose monitoring system has seemingly slowed to a snail's pace. And the dynamic growth opportunity envisioned two years ago, when Medtronic bought MiniMed, is now impinging on the parent corporation's balance sheet.