Medical Devices
Medical Imaging Cable Assembly: 500 Units / Quarter
Redesigned and scaled a patient-side imaging cable assembly from a low-yield supplier to a stable 500-unit-per-quarter program with full traceability.
Challenge
Customer's incumbent supplier was returning >8% failure rates on hipot, blowing through schedule and triggering field returns. They needed a partner who could re-tool the build, hold tolerance, and ship documented lots on a quarterly cadence.
Solution
Re-engineered the strip-and-crimp profile, introduced crimp-force monitoring on the production line, and instituted 100% hipot test with serialized per-unit records. Built dedicated form-board tooling for repeatable routing.
Process
- DFM review of the legacy drawing pack
- First-article approval against agreed gauge & sample
- Production cell stood up with crimp-force monitoring
- 100% hipot + continuity on every unit
- Serialized records archived with each lot ship
Outcome
- Hipot failure rate dropped from 8% to under 0.2%
- On-time delivery at 100% for the last 6 quarters
- Full lot traceability ready for FDA documentation
- Customer consolidated 3 cable SKUs to VezeWire