How medical device manufacturing organizations apply kaizen and lean philosophies for continuous improvement

To remain competitive and profitable, an organization must continuously improve its processes and meet its customers' needs. Over time, innovation of new products is an insufficient method for meeting these goals. Organizations benefit from the small incremental changes of kaizen and from the lean focus on customer-defined value and elimination of waste.;Regulatory standards of the medical device industry require that organizations maintain the effectiveness of the quality management system and produce safe and effective medical devices. These standards do not include requirements for continual improvement; however, provided the organization remains compliant with regulatory standards, medical device organizations can improve process efficiency and responsiveness to customers by implementing kaizen and lean.;To assist medical device organizations implementing kaizen and lean, this thesis reviews the principles and benefits of these philosophies and summarizes their application at two medical device manufacturing organizations.