The list of features in medical devices is rapidly rising: Even the simplest of medical devices house more and more system components, which add greater functionality to the device at a low cost. But by adding components, device software becomes complex and burdens compliance testing and premarket certification activities. 

This paper is the second in a two-part series exploring the innovation barrier – the point at which testing can no longer keep pace with development in the equipment manufacturing industry. It examines the innovation barrier’s symptoms – from slowdowns in development to mounting quality issues – and the potential impact on equipment manufacturers.