The effect of medical device regulations on deploying a Lean Six Sigma project
McGrane, Vincent ; McDermott, Olivia ; Trubetskaya, Anna ; Rosa, Angelo ; Sony, Michael
McGrane, Vincent
McDermott, Olivia
Trubetskaya, Anna
Rosa, Angelo
Sony, Michael
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Repository DOI
Publication Date
2022-11-05
Type
Article
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Citation
McGrane, Vincent, McDermott, Olivia, Trubetskaya, Anna, Rosa, Angelo, & Sony, Michael. (2022). The Effect of Medical Device Regulations on Deploying a Lean Six Sigma Project. Processes, 10(11). doi:10.3390/pr10112303
Abstract
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.
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Publisher
MDPI
Publisher DOI
https://doi.org/10.3390/pr10112303
Rights
CC BY-NC-ND 3.0 IE