Representative image — customer parts covered by NDA
Customer background
A medical device company needed a manufacturing partner for high-volume production of stainless steel surgical instrument components. Beyond precision, the decisive requirement was documentation: every part had to be traceable to its material lot, machine, and inspection record to satisfy regulatory audits.
The challenge
The components were machined from 316L stainless steel — a gummy, work-hardening material — and required a mirror surface finish on patient-contact surfaces. Volumes ran to tens of thousands of parts per month, so the process had to hold tolerance over long unattended runs, not just on a good day. And complete lot traceability had to survive high-volume flow without slowing it down.
Our solution
We built dedicated automated production cells for the part family: bar-fed CNC turning with live tooling for the rotational components and fixtured milling cells for the prismatic ones, running under our 24/7 lights-out system. In-process gauging inside each cell measured critical features every cycle and compensated tool wear automatically before dimensions could drift.
Barcode tracking was applied from raw bar to packed carton: each container carries a lot ID linking material certificates, machine logs, and CMM sampling records. Electropolishing and passivation were handled in-line, with surface roughness verified against the mirror-finish spec on a sampling plan.
Project specifications
| Material | Stainless steel 316L |
| Process | Automated turning & milling cells, 24/7 production |
| Volume | 50,000+ parts per month |
| Finish | Mirror polish + passivation on contact surfaces |
| Traceability | Full lot traceability, barcode tracked |
| Industry | Medical devices |
Results
The cells sustain 50,000+ parts per month at a 0.02% defect rate, with 100% lot traceability maintained across every shipment. Audit requests that previously took the customer days to answer are now resolved with a single lot-ID lookup. The program has run continuously since launch and expanded to additional instrument lines.
