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Medical Device Designers Avoid the Pitfalls of Outsourcing Medical Tubing
Date:3/10/2010

with an application to validate metal tubing requirements. For instance, small-diameter miniature tubing is becoming increasingly important because miniature devices are becoming the norm.

“This creates a need to put more materials or devices through a smaller ID tube,” Heft explains. “When you put multiple devices, such as fiber optics, other tubes, guidewires, and even stents, through a narrow laparoscopic or endoscopic tube, for example, you get a ‘stack-up’ of tolerances. That results in costly problems. With miniature tubing, it becomes more important that the ID is accurate, the inner surface is smooth without burrs, roughness or debris which could cause damage to the materials, and that the instrument is engineered so that it does not develop kinks.”

TAKING QUALITY CORRELATION FOR GRANTED
It’s important to find a provider that ensures quality measurement techniques are correlated between both parties, products are being inspected properly, and are being run through the necessary tests to make sure they perform.

“A thorough supplier of metal tubing for medical devices will eliminate such design problems before they become product problems. They know how different alloys are produced and fabricated and the various mechanical and chemical properties that are available from different materials, as well as what tube fabrications can be realistically expected and how far the envelope can be pushed.”

Quality credentials are very important. Many suppliers of medical device components are ISO-9001 certified. But when a medical tubing manufacturer has ISO-13485 certification, that credential indicates a supplier has very high quality standards, not only in products, but also systems. “With the FDA and other authorities becoming more involved in
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