How closed-loop machining precision enabled a medical guidewire manufacturer to improve their Cpk value from 1.0 to 1.67.
The Challenge
A medical device manufacturer producing stainless steel guidewires struggled with diameter variations that fluctuated near the tolerance limits. Their existing process had a Cpk value of 1.0, necessitating 100% inspection and frequent lot rejections.
Titan Engineering Solution
Titan deployed a closed-loop laser measurement system during the die sizing process. We manufactured a matched set of dies where the bearing length and diameter were controlled to within ±0.3μm of the target nominal. We also adjusted the bearing length to 35% of the diameter to improve stability.
Fig 1. Analysis and Implementation
The Results
The consistent die geometry stabilized the drawing process. The customer's Cpk value improved to 1.67, classifying the process as 'highly capable' and allowing them to move to sampling-based inspection, saving significant QA costs.
Key Takeaways
- Die geometry consistency directly correlates to wire Cpk.
- Closed-loop manufacturing eliminates human error in sizing.
- Higher process capability reduces QA overhead.
Facing a similar issue?
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