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 field gateway maker traced recurring thermal-cycling failures to a stack-up problem and worked with Copperline to redesign for reliability.
An industrial IoT gateway manufacturer was seeing a field failure pattern concentrated in outdoor deployments with heavy thermal cycling — intermittent connectivity failures traced back to microcracking in specific via locations after repeated expansion and contraction, on an existing 10-layer board.
Copperline's engineering team reviewed the failed units alongside the original stack-up and identified an aspect-ratio issue in the affected via locations combined with a dielectric material not well suited to the temperature range the units actually saw in the field. A revised 10-layer stack-up with adjusted via aspect ratios and a higher-Tg dielectric was proposed and validated through accelerated thermal-cycling testing before full production cutover.
Post-redesign units have run through two full outdoor deployment seasons with zero recurrence of the failure pattern. The gateway now ships at 6,500 units/year with the revised stack-up as the qualified baseline design.
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