Track: Manufacturing

Abstract

Coatings of guidewires used in medical device manufacturing industry are one of the most important aspects. It defines its efficiency to penetrate through tightest of canals and curves. Guidewires are put through controlled environment to accelerate its age and tested for its mechanical features. Pressure Guidewire failed the lubricity testing after being tested by multiple operators and at alternate sites. A cause-and-effect diagram shows all potential causes of test failure. The human factor involved in the test failure was investigated through multiple Gage R&R and training records. Calibration error with the lubricity tester DL1000 was identified and solved through preventive maintenance work order. The failed samples were examined under Scanning Electron Microscope and detailed images showed coating wearing off from T=2years samples. The thickness of coating indicated that samples are unable to sustain environmental change after two years’ time. A two-factor design of experiment factorial was conducted to see the effects of factors on distal and proximal sections of the wire. The actual setting of Corona distance 5mm and Dip speed 60mm/min seem to affect the coating of proximal section during aging process. A new optimize setting of Corona distance 2mm and Dip speed of 30mm/min proved to provide better coating that can sustain the wire over the 2 years. Similarly, for distal section of Pressure Guidewire, UV intensity of 6.0 and Corona time of 30seconds showed better results as compared to original setting. A confirmation study was conducted to prove the effects of new changes implementation and process capability showed that the results were under control. The findings of new optimal coating settings can improve the guidewire’s ability to work after 2 years’ time.