LAPSE:2023.0833
Published Article
LAPSE:2023.0833
The Effect of Medical Device Regulations on Deploying a Lean Six Sigma Project
February 21, 2023
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.
Keywords
21CFR 820, continuous improvement, ISO 13485, Lean Six Sigma, medical device, MedTech, validation
Suggested Citation
McGrane V, McDermott O, Trubetskaya A, Rosa A, Sony M. The Effect of Medical Device Regulations on Deploying a Lean Six Sigma Project. (2023). LAPSE:2023.0833
Author Affiliations
McGrane V: Department of Engineering, University of Limerick, Castletroy, V94 T9PX Limerick, Ireland
McDermott O: College of Science & Engineering, University of Galway, H91 TK33 Galway, Ireland [ORCID]
Trubetskaya A: Department of Engineering, University of Limerick, Castletroy, V94 T9PX Limerick, Ireland [ORCID]
Rosa A: Department of Management Studies, Università LUM Jean Monnet, 70010 Casamassima, Italy [ORCID]
Sony M: Wits Business School, University of the Witwatersrand, Johannesburg 2193, South Africa [ORCID]
Journal Name
Processes
Volume
10
Issue
11
First Page
2303
Year
2022
Publication Date
2022-11-05
Published Version
ISSN
2227-9717
Version Comments
Original Submission
Other Meta
PII: pr10112303, Publication Type: Journal Article
Record Map
Published Article

LAPSE:2023.0833
This Record
External Link

doi:10.3390/pr10112303
Publisher Version
Download
Files
[Download 1v1.pdf] (545 kB)
Feb 21, 2023
Main Article
License
CC BY 4.0
Meta
Record Statistics
Record Views
56
Version History
[v1] (Original Submission)
Feb 21, 2023
 
Verified by curator on
Feb 21, 2023
This Version Number
v1
Citations
Most Recent
This Version
URL Here
https://psecommunity.org/LAPSE:2023.0833
 
Original Submitter
Auto Uploader for LAPSE
Links to Related Works
Directly Related to This Work
Publisher Version