Medical device programs require more than dimensional capability. They need documentation discipline, stable process control, and the ability to repeat quality across long production runs. This project started when a French OEM needed to transfer a machined enclosure family without disrupting a product launch already tied to regulatory timing.
The housing combined cosmetic exterior surfaces with tight internal relationships for mounting optics, bearings, and sealing components. The incoming drawing package was clear, but the prior supplier had not built a machining and inspection system robust enough for repeat high-volume execution.
Solution Snapshot
We redesigned the fixture strategy around one-datum machining, introduced in-process probing for critical bores, and built a streamlined FAI approval workflow that supported fast scale-up without losing traceability.
The manufacturing challenge
The part included multiple machined faces, thin wall sections, and precision bores that had to maintain positional relationships through anodizing and final assembly. The OEM had already experienced rejection spikes due to bore drift and visible cosmetic handling marks.
Production timing was equally important. The client needed a clean transition plan that would support pilot lots, first article approval, and then immediate ramp to tens of thousands of units.
- Tight dimensional relationships across multiple datum surfaces.
- Cosmetic exterior finish with low tolerance for handling damage.
- Fast launch schedule with controlled documentation and traceability.
Our process strategy
We standardized the route around dedicated fixtures that reduced setup variation and supported consistent bore location from a stable datum structure. In-process probing flagged drift before it became a scrap event, while custom soft handling between machining and finishing protected visible surfaces.
Inspection planning was aligned to risk. Critical bores, thread quality, and sealing interfaces were checked at defined frequencies, while cosmetic review standards were locked through approved reference samples.
- Dedicated fixturing for repeatable datum control.
- In-process probing on critical bore features.
- Golden-sample cosmetic approval before mass production release.
Business outcome
The client secured a lower landed cost without sacrificing quality confidence. Just as important, the process transferred into routine production with predictable reporting, which reduced engineering follow-up and helped the OEM focus on its launch schedule instead of supplier firefighting.
After the initial housing family stabilized, the program expanded into adjacent machined parts that could use the same communication and quality framework.
- Lower total supplier-management overhead for the buyer team.
- Smooth expansion from pilot to serial production.
- Framework reused across additional machined SKUs.