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.

Automated summary

This study investigates the differences in timelines involved in Lean Six Sigma project deployment in regulated and unregulated industries. The transfer of manufacturing lines in the medical device and electronics manufacturing sites is compared through two case studies. The study highlights the impact of regulatory procedures on project implementation and timelines.