Case study — Medical devices
Implant family migrated in one quarter
A device maker moved 23 machined implant components to a new supplier without a single lot rejection.
The challenge
The incumbent could no longer hold the ±0.005 mm bone-interface tolerances at growing volumes, and revalidation risk made a slow, staged transfer essential.
What we changed
Process transfer in 4 stages: CMM correlation runs, first-article packs per part, process-window studies, then staged volume release under the customer's own validation protocol.
Results
- Lots rejected
- 0 of 214 demo data
- Cpk on interface features
- 1.67 demo data
- Unit cost
- -11% demo data
Zero lot rejections across 214 lots during the transfer. Atlas ran the validation protocol our way and shipped on schedule.