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

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