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,” says Lance Heft, CEO of International Tube,
Pottstown, PA (PRWEB) March 10, 2010
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.
Here are the top three pitfalls to avoid when outsourcing metal tubing for medical devices:
“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. 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,” says Lance Heft, CEO of International Tube, a major supplier of medical tubing to the medical device industry. “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.”
UNDER OR OVER-ESTIMATING REQUIREMENTS
Prospective vendors should be qualified according to their experience 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 the monitoring of a medical device company’s activities and quality, they need to have a vendor that has 13485 compliance. The FDA is getting more and more active, and this is another level of comfort for them.”