New and innovative approaches to drug discovery tools, in-home dialysis care, diagnostic lab automation, and haptic feedback surgical tools have generated significant demand for equally innovative sensors to provide control data for the safe and accurate performance of these medical devices.

Obtaining market approval for a new product can create several clinical challenges for medical device Sponsors. One way in which to tackle these challenges head-on is to develop effective biostatistics processes and plans early in the development process to navigate these complexities.