Case Studies

AI that earned its place on the floor

Problem, approach, and measured result — and how we kept each one validated and audit-ready.

Process DevelopmentValidation & GovernanceQuality & InspectionSmart Factory & Data

The case studies below are representative and anonymized to protect client confidentiality. They illustrate our typical approach and the kind of outcomes engagements target; figures are indicative ranges, not guarantees, and vary with each operation.

01
Medical Device (Class II)AI-Augmented Process Development

Cutting scrap on a high-cavitation tool with ML process control

Challenge

A Class II molder ran a 32-cavity tool with persistent scrap from short shots and dimensional drift, especially when switching resin lots. Operators chased the process manually, and scrap spiked after every material change.

Approach

  • Characterized the baseline with scientific molding and validated existing sensor data quality
  • Trained an ML surrogate model mapping process parameters and material state to part quality
  • Used multi-objective optimization to balance scrap, cycle time, and dimensional capability
  • Deployed parameter recommendations, then closed the loop for lot-to-lot adaptation

Result

  • Scrap reduced in the high-teens %
  • Reduced dimensional drift across lots
  • Faster, calmer material changeovers

Kept Audit-Ready

Model and acceptance criteria documented; changes managed under the site's process-validation framework.

02
Medical Device (Class III)AI-Driven Quality & Inspection

Validated vision inspection that passed a notified-body audit

Challenge

A manufacturer wanted automated vision inspection for cosmetic and dimensional defects on an implantable-device component, but prior attempts stalled because the model couldn't be validated or explained to auditors.

Approach

  • Defined intended use, operating range, and acceptance criteria (sensitivity / false-negative limits) up front
  • Applied Computer Software Assurance (CSA) — deepest testing on the highest-risk failure modes
  • Built explainability into the model so rejections could be understood by a quality engineer
  • Produced IQ/OQ/PQ-style validation evidence and a model-governance plan

Result

  • Inspection model validated and in production
  • Clean notified-body audit of the system
  • Lower manual inspection load

Kept Audit-Ready

Full validation package, explainability evidence, and a Predetermined Change Control plan for future retraining.

03
AutomotiveSmart Factory & Data

Targeted predictive maintenance on the assets that actually mattered

Challenge

An automotive molder lost expensive production time to unplanned press and auxiliary-equipment failures, and a prior 'sensors everywhere' pilot had produced data nobody used.

Approach

  • Ranked assets by downtime cost and failure predictability — focused only on the high-consequence few
  • Built the IIoT data foundation (reliable time-series collection) before any modeling
  • Modeled degradation signatures on critical presses and auxiliary equipment
  • Set condition thresholds tied to maintenance workflows, not just dashboards

Result

  • Fewer unplanned stoppages on targeted assets
  • Higher OEE on the affected lines
  • A data foundation reused for later AI work

Kept Audit-Ready

Scoped honestly — assets where predictive maintenance didn't pay were left on preventive schedules.

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