The Effect of Medical Device Regulations on Deploying a Lean Six Sigma Project

This paper investigates the differences in timelines involved Lean Six Sigma (LSS) project deployment a regulated industry versus an unregulated one. Two case studies utilising methods—in order to compare transfer of manual manufacturing lines within medical device and electronics site—are discussed utilised. research aims show effects regulatory procedures on LSS implementation timelines. study particularly highlights how environment can be barrier, or bottleneck, management, continuous improvement, engineering changes MedTech industry. The results this represent important first step towards full understanding influence regulations operations devices and, by extension, pharmaceutical industries global scale. limitations are that data collected were from two specific comparisons alone.