The medical device industry is in the midst of a redefining transformation, posing both opportunities and threats to manufacturers’ current business model. Global device companies must address significant operational challenges to ensure that monitoring and safety surveillance practices address growing concerns about the safety of products introduced to the market.

Recalls of medical devices nearly doubled between 2003 and 2007, and increasingly, the safety issues involved have less to do with the manufacturing of the device than their design and the way they are used. The number of recalls results, in part, from the increasing complexity and growing number of devices, coupled with nominal approval and post-market safety requirements. Another contributing factor is cultural, though.