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- Title
The Effect of Medical Device Regulations on Deploying a Lean Six Sigma Project.
- Authors
McGrane, Vincent; McDermott, Olivia; Trubetskaya, Anna; Rosa, Angelo; Sony, Michael
- 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.
- Subjects
SIX Sigma; MEDICAL laws; MEDICAL electronics; MEDICAL equipment; ELECTRONICS manufacturing; REGULATED industries
- Publication
Processes, 2022, Vol 10, Issue 11, p2303
- ISSN
2227-9717
- Publication type
Article
- DOI
10.3390/pr10112303