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...
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| Veröffentlicht in: | Processes 2022-11, Vol.10 (11), p.2303 |
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| creator | McGrane, Vincent McDermott, Olivia Trubetskaya, Anna Rosa, Angelo Sony, Michael |
| description | 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. |
| doi_str_mv | 10.3390/pr10112303 |
| format | Article |
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| subjects | Case studies Compliance Continuous improvement Federal regulation Industrial project management ISO standards Lean manufacturing Manufacturers Manufacturing Medical device industry Medical equipment Medical research Medical technology Pacemakers Physiological apparatus Project management Quality management Regulated industries Regulations Six Sigma |
| title | The Effect of Medical Device Regulations on Deploying a Lean Six Sigma Project |
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