Sanofi’s iBGStar blood glucose monitor. ProUroCare’s prostate imaging system. Edwards Lifesciences’ ThruPort IntraClude intra-aortic occlusion device. More new products.

This article was excerpted from "Top Device Stories of 2009: A Year of Economic Revival and Regulatory Risk," IN VIVO, January 2010.

Last year saw a surprising number of investments in devices for urology but the development activity in this space should not be surprising, given that prostate disease-both prostate cancer and BPH-are diseases of aging, setting in after age 40 when hormonal changes may cause the prostate to enlarge. BPH, for example, affects more than 50% of men age 60 and older and 90% of men age 70 and older. Prostate cancer is the second-leading cause of carcinoma death in men. These demographic trends are reflected in the rapid growth in surgical procedures for the treatment of prostate disease, many of which are projected to grow at high double-digit rates in major global economies, according to a series of reports detailing surgical volumes and trends by country, published by the Medtech Insight division of Elsevier Business Intelligence.

2009 was the most difficult year the device industry faced in a long time, particularly given the boom years that preceded it. Public and private investors grew nervous and sat on the sidelines, as did most corporate acquirers. As a result, most start-ups found it difficult to raise money and VCs were frustrated by the poor returns being generated, especially compared with the previously frothy climate. The silver lining may be that there are signs that the economic environment may be improving and that corporate acquirers will continue to pay a premium for the right deal. Overhanging all of this, however, is the specter of health care reform and its impact on the device industry, whether through a device tax, comparative effectiveness or some unanticipated other result, meaning the industry is far from out of the woods.