This article first appeared in Medtech Insight, October 2010.

The global economic downturn has put pressure on large, consumer-based in vitro diagnostic markets, such as diabetes glucose-testing, driving down sales, pricing, and profits. As a result, the IVD industry is actively seeking out higher growth opportunities to offset this impact-and it is finding solutions in several areas, branching into underserved emerging markets like China and India and targeting higher-growth clinical segments such as cancer, women's health, and infectious disease. But perhaps the biggest opportunity for future growth lies in the field of molecular diagnostics, particularly products that address the move toward more personalized care. Suppliers well positioned to take advantage of this opportunity are likely to experience strong growth ahead.

The market for home health care products, valued at $4.3 billion today, is one of the largest and most stable medtech markets in the US, according to "US Markets for Home Health Care Products," a report recently published by the FDC-Windhover division of Elsevier Business Intelligence. Like most health care markets, it owes its growth to the burgeoning aging population. This population will only grow. As the larger elderly segment of the population ages, they'll require care. But rising health care costs have forced patients to recover from disease and injury at home rather than in an acute care or even rehabilitation setting. A dangerous shortage of facilities, nurses and other skilled health care personnel adds to the pressures and ensures strong growth in the home health care market for the foreseeable future.

As 2008 draws to a close, In Vivo takes stock of the major events affecting the medical device industry in 2008. Two stories continue to unfold; how the new Obama administration will control national health spending, and the financial crisis that hit the US and global economies. The latter is already taking its toll on medtech. Financial markets crashed, and so did public device companies. M&A dwindled as the year went on, with some notable--and surprising--exceptions, and the downturn is driving VCs to invest either extremely early or late. In other stories: the Department of Justice continued probing into physician conflict of interest matters, this time focusing on the influential Cardiovascular Research Foundation. Also from Washington, the 510(k) process is under review, and 2009 may see changes that make the process of demonstrating safety and effectiveness more costly for device companies. CMS instituted payment reforms affecting hospitals, although this may be good news for medtech companies offering products to help curb hospital-acquired infections and medical errors. The news was good in diabetes--for devices, not pharmaceuticals--with positive outcomes from a major trial on continuous glucose monitoring and two new markets opening up in diabetes for device manufacturers. The regulatory agency delivered some positive news to companies in cardiac rhythm management and neurostimulation too. And second generation drug-eluting stents found a market more receptive than it was a year ago.