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.

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.

Lack of sleep is bad in its own right, but now the knowledge that obstructive sleep apnea is a risk factor for and even a possible cause of heart disease adds urgency to what the medical community has until recently viewed as a quality of life problem. However, the existing infrastructure for diagnosing and treating OSA can neither handle the current demand nor the expected influx of new patients coming in from the cardiology community. New companies hope to fill gaps in diagnosis and therapy, but they face all the challenges of establishing technological and business approaches in an evolving field, with the need to change practice patterns, educate patients and multiple groups of physicians, and win the buy-in of payers.