How Medical Device Designers Can Avoid the Pitfalls of Outsourcing Medical Tubing
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POTTSTOWN, Pa.--There's a stiff price to pay for those who choose not to consult with a knowledgeable medical tubing supplier. Unless certain steps are taken to ensure that designs and specifications are accurate, the potential consequences include exceeded R&D budgets, exorbitant production costs, delay of FDA approval, slowed speed to market, and a great deal of frustration. However, by qualifying and partnering with a metal tubing supplier, most of the pitfalls that cause such problems can be identified and avoided.
Lance Heft, CEO of International Tube, says companies need to avoid a number of pitfalls when outsourcing metal tubing for medical devices. The top three pitfalls to avoid, he says, are tolerance issues, under- or over-estimating requirements, and taking quality correlation for granted. Based in Pottstown, Pennsylvania, International Tube is a major supplier of medical tubing to the medical device industry.
"Many engineers look at tolerances in terms of the upper and lower extremes--they don't take tolerance stacking, effects of secondary operations, or ID clearance issues into account," says Heft. "If these items are not specified properly and prototype runs are ordered, the engineer loses monetary investment, plus time, which translates into missed product release deadlines, or even worse--recalls. These are critical factors that can happen in production runs. We bring those types of questions up in the initial meeting with a customer to ensure engineers get what they want in their initial prototype run."
Prospective vendors should be qualified according to their experience with an application to validate metal tubing requirements, Heft says. 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."
It's important to find a provider that ensures that quality measurement techniques are correlated between both parties, products are being inspected properly, and products 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," Heft continues. "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 the monitoring of a medical device company's activities and quality, they need to have a vendor that has 13485 compliance," says Heft.
International Tube (www.internationaltube.com) also provides specialty metal tubing to the aerospace, electronics, and industrial marketplaces.
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