Lean and Six Sigma aid in improving medical device quality and cost reduction. In 2021, the overall medical devices market exceeded $335 billion. We’ll look at a case study using Lean Six Sigma with respect to non-compliance costs and a short interview on the importance of Lean Six Sigma in the medical device industry. Finally, we’ll reference a video of medical device packaging.


Using Lean Six Sigma to Reduce Regulatory Noncompliance Costs


In a case study titled “Application of Lean Six Sigma to reduce the cost of Regulatory noncompliance,” authors Reham Nour and Chad Laux discuss the use of Lean Six Sigma to improve the effectiveness of the Corrective Action and Preventive Action (CAPA) process for a medical device company.

The case study includes:

  • Project Charter
  • Critical Customer Requirements
  • Current Performance and System Gaps
  • 5 Whys Root Cause Analysis
  • CAPA Process Turtle Analysis
  • Recommendations
You can read the case study here.


The Importance of Lean and Six Sigma in Medical Device Manufacturing


In an article from Medical Device and Diagnostic Industry Online titled “Why Lean and Six Sigma Should Matter to You,” author Brian Buntz covers an interview with Dave Schleder, director of OEM/international operations at B. Braun by Medical Product Manufacturing News (MPMN).

You can read the short interview here.


Video on Manufacturing Medical Device Packaging


See how packaging is done inside Brentwood Industries’ Clean Room.

You can watch the video here.


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