EDM & MARKING IN IRVINE

Irvine is about twenty miles south of our floor in Yorba Linda, and the work that comes out of it looks different from anywhere else in the county. This is the medical device cluster.

Roughly 40,000 people work in device manufacturing and R&D across the Orange County–Santa Ana area, generating an estimated $8.2 billion in regional economic output according to Biocom California’s 2024 report. Edwards Lifesciences alone employs more than 5,000 people in the city building heart valves and hemodynamic monitoring systems. Masimo builds pulse oximetry sensors here. Medtronic Neurovascular, B. Braun and Johnson & Johnson’s medtech campus all operate in Irvine, and around them sits a long tail of firms making surgical instruments, orthopedic implants and diagnostic equipment.

That concentration shapes what Irvine sends us: smaller parts, tighter callouts, stricter documentation, and marking requirements that are regulatory rather than cosmetic.

What medical work demands that other work does not

Marking is a compliance requirement, not a finishing touch. UDI marks on implantable-grade stock have to survive cleaning and sterilisation cycles without creating a crevice or a corrosion site. We anneal rather than ablate on those parts, so the surface stays passivation-safe, and every mark is graded in-line to ISO/IEC 29158 before it ships.

Traceability has to hold. First-article inspection reports with full dimensional layout, material certifications and certificate of conformance ship as standard, and lot traceability is maintained against your part number. Consignment material is receipt-inspected and logged.

The materials are unforgiving. 316L, 17-4 PH, titanium and PEEK, usually in thin sections where cutting pressure would distort the part. Wire EDM applies no tool force at all, which is why instrument bodies and fine detail end up on wire rather than in a cutter.

Processes Irvine uses most

• Laser part marking — UDI, 2D data matrix and serialisation, annealed for passivation-safe finishes, graded before shipping.
• Wire EDM — ± 0.0001″ positional with 0.0025″ minimum internal corner radius, no burr and no heat-affected zone.
• Hole-popping EDM — irrigation and lumen holes from 0.004″ diameter, including compound angles on curved surfaces.
• Industrial 3D printing — inspection fixtures and holding jigs in carbon-filled nylon, built overnight so a validation run is not waiting on tooling.

Logistics and confidentiality

Twenty miles is a comfortable courier run in both directions, and Irvine parts are usually small enough that freight is never the constraint. Device geometry is commercially sensitive long before it is patented, so if your programme needs a non-disclosure agreement in place before drawings move, tell us and we will sign one the same day rather than after the quote.

Certifications

AS9100D and ISO 9001:2015 certified. While AS9100 is an aerospace standard, the underlying quality discipline — documented process control, first-article inspection, full material traceability — is what medical device buyers are auditing for, and it is the same system every job here runs against.

Send a print for a 24-hour quote, or email it to quotes@aerox.aero.