MES

Leading medical device manufacturer eliminated 1,800 pages of daily paperwork by implementing Critical Manufacturing MES across extreme vertical integration from weigh/dispense through tertiary packaging. The 24-month implementation achieved 66% faster changeovers, full CFR 21 Part 11 compliance, and eliminated mislabeling incidents. Key success factors included dedicated MES modeling teams, agile development methodology, and comprehensive integration with Oracle EBS, Agile PLM, and OPC-UA devices. The multi-million dollar investment delivered measurable ROI through operational efficiency, quality improvements, and FDA audit readiness.

A leading dental manufacturer invested $25,000 in an AI vision system POC to automate FDA-required date stamp verification, aiming to eliminate costly dual signatures consuming 2 hours daily. Despite achieving zero false positives in laboratory conditions, excessive false negatives from lighting variations and magnification challenges made production deployment unfeasible. Rather than pursuing a costly pilot, the team implemented a human-centered Andon cord solution. This intelligent failure prevented $150,000+ in pilot investment while delivering strategic learning and faster operational improvements. Sometimes people remain the optimal answer.