Medical Device Class II Diagnostic Device — Sensor Board Requalification
A Class II diagnostic device maker requalified a failing sensor board line without slipping a regulatory-locked launch date.
- Layers
- 8
- Volume
- 18,000 units/year
A consumer electronics brand needed a single manufacturing partner to carry a product from low-volume launch through mainstream retail volume.
A consumer electronics brand launched a new product through a small-batch prototype run and needed a manufacturing partner who could scale the same 4-layer design to mainstream retail volume without a design freeze delay or a second requalification cycle at a different vendor.
Copperline ran the original prototype files through DFM review to confirm the design would hold acceptable yield at scale, made minor panelization adjustments to improve utilization on the standard fab panel, and validated the change against the original design intent before committing to volume tooling — avoiding a second full requalification cycle.
The product scaled from an initial small-batch run to 85,000 units/year on the same qualified design, with the panelization adjustment alone improving effective unit cost enough to hold the brand's target retail margin without a price increase.
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