Executive Summary

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.