Manual calliper inspection replaced with non-contact VMM. Inspection time from 9 minutes to under 45 seconds. ISO 13485 audit records automated. Zero field complaints in 8 months.
A manufacturer of single-use surgical cannulas, trocars, and laparoscopic access devices in Pune — supplying to hospital chains and surgical distributors across India and the Middle East — was facing escalating quality pressure. Their product range included stainless steel and medical-grade polymer cannulas with outer diameters from 3 mm to 12 mm, wall thicknesses of 0.15–0.35 mm, and burr-free tip geometries. Tolerance callouts of ±5 µm on OD and ±0.02 mm on wall thickness were standard for their premium surgical range. Manual inspection with hand-held micrometers and tube micrometers was slow (7–9 minutes per component) and producing inconsistent results — Gauge R&R at 28% due to operator-to-operator variation on small-diameter features. ISO 13485 required full electronic inspection records; the team was generating paper-based records and transferring them manually to the QMS.
Optomech installed the VMM CNC-HD (Vision Measuring Machine, CNC, High Definition) — a motorised non-contact measurement platform with a 20 MP telecentric camera, 200 × 150 mm stage, and sub-micron repeatability. The system was configured with a rotary fixture for cannula OD and wall thickness measurement, enabling automatic measurement of 6 diameters, 4 wall thickness readings, and tip angle in under 45 seconds per part. The Optomech applications team programmed 18 CNC part routines covering the full product range in 3 days. Measurement data is exported to Excel with automatic ISO 13485 record format — including lot number, part ID, operator, date, all measurements, and pass/fail status. The system is calibrated against NABL-traceable artefacts supplied with the instrument.
| Metric | Result |
|---|---|
| Measurement repeatability | ±2 µm on OD and wall thickness — confirmed against NABL masters |
| Inspection time | 7–9 min manual → under 45 seconds per cannula (92% reduction) |
| Gauge R&R | Reduced from 28% to 4.9% — well within ISO 13485 requirement |
| ISO 13485 records | Auto-generated at end of each inspection — no manual data transfer |
| Burr detection | 100% tip geometry inspection — burr angle and height measured automatically |
| Lot traceability | Full electronic records with lot number, date, operator, and calibration reference |
| Part programs | 18 CNC programs covering all 32 active SKUs |
| Field complaints | Zero dimensional field complaints in 8 months post-installation |
"Our cannulas go into surgery. A dimensional non-conformance is not just a quality failure — it's a patient safety issue. The VMM gave us the measurement confidence we needed. ±2 µm repeatability, automated ISO 13485 records, and our inspectors are not tied up for the whole shift. Our auditor commented that our inspection records were among the best they had seen at a mid-sized device manufacturer."
Contact our medical device metrology specialists to discuss how the VMM CNC-HD can improve your measurement confidence and quality compliance.
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