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.

Brief summaries of recent medtech market and industry developments. This month we cover secondary buyers as an exit strategy for Boston Scientific and others; a review of medtech dealmaking in the first quarter of 2008, and US markets for patient monitoring products.

The first quarter of 2008 saw a dearth in financings for both the medical device and in vitro diagnostics segments. In the former, volume fell short of the billion dollar mark while the latter failed to reach the success the previous quarter had witnessed, despite completing an equal number of transactions. M&A in medical devices didn't look any more promising, bringing in $1.6 billion, a huge slide from the impressive $10 billion total of 2007's fourth quarter. However, there was one bright spot: acquisitions within in vitro diagnostics/research reagents substantially increased to $3.1 billion from the $370 million spent in the previous three months, led by Inverness Medical Innovations' $1.1 billion takeover of Matria Healthcare Inc. Also noteworthy: oncology diagnostics alliances grew slowly and steadily thanks to increasing attention from larger companies.

When GlucoLight was founded in 2003 to bring to market an optical platform for non-invasive glucose monitoring-specifically, optical coherence tomography-its founders decided to set themselves apart from the pack in two ways. First, they would focus on generating clinical data, and letting that data speak for itself. The company has conducted six clinical trials to date. Second, they would validate its platform in an emerging market that needs a technological solution but that is well-validated from the clinical perspective: glucose monitoring in the hospital critical care environment. This market also offers a faster time to market because there is no requirement to miniaturize the monitor for the ICU environment. Part of a group of articles that includes: "Where are They Now? Checking in on Three Glucose Monitoring Companies," "A Decade of Development of SMSI: Will it Yield Improved Accuracy in CGM?" and "Pelikan Swoops in on the Big Four."