Applying Lean & Six Sigma Strategies to Medical Device Manufacturing

by Michael B. Checketts published on July 21, 2020

Within the controlled medical device manufacturing sector, there is a general “resistance” to change. This is not without good reason. If all potential risks of a change are not mitigated before implementation, the potential of compromising the safety and/or efficacy of the device’s end use requirements could be greatly compromised. In reality, if correct processes are put into place to mitigate risks as laid out within ISO 13485 and ISO 14971 parameters, there is no reason to doubt the deployment of Lean Six Sigma for medical device manufacturing and its potentially great benefits.


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