Operational excellence is fundamental to achieving superior quality, regulatory compliance, and patient safety throughout the medical device lifecycle, starting with precise requirement definition. Key challenges include managing complex requirements, regulatory adherence, supply chain intricacies, technology integration, continuous improvement culture, and cost control. Addressing these involves implementing established principles like Lean Manufacturing, Six Sigma, and Total Quality Management (TQM) to eliminate waste, reduce variation, and embed quality focus organization-wide. Monitoring Key Performance Indicators such as First Pass Yield (FPY), Process Cycle Efficiency (PCE), and Customer Complaint Rate is essential for tracking effectiveness.

Read more at: qualitymag.com