Medical device quality: An essential capability and competitive edge for manufacturers
In our experience, there are three root causes for the rising incidence of product failures in the medical device industry: a siloed, reactive approach to quality; a lack of focus on continuous improvement; and the ever-increasing complexity of medical devices. To address them, manufacturers should consider developing quality management as an organizational capability. The principal components of such a capability are critical-to-quality (CTQ) management, systems engineering, and design for Six Sigma (DFSS). Companies that successfully weave these three elements into an integrated, preventive quality capability can achieve a competitive advantage and a leadership position in their industry.