在与金属管供应商合作时，注意一些关键细节可以确保您的医疗设备设计按时和预算不足。
1Watch tolerance stacking. When you are figuring tolerances in terms of upper and lower extremes, also take into account tolerance stacking and the effects of secondary operations and ID clearance issues. Accounting for these factors in a design prior to prototyping will save money and time.
2不要使用不合格的输入。虽然互联网是信息的来源，但并非所有有关信息的信息都是准确的。供应商和供应商在确保其网站上的信息是最新的。International Tube首席执行官Lance Heft说：“互联网甚至一些参考书的问题是，他们可能会鼓励选择一种可能不可用或不适合该应用程序的异国情调材料。您的供应商应该能够解释此类问题。”充分了解管道的不同制造方法以及与最终产品的性能有何关系是有帮助的。
许多管设计和配置包括冶金，管形成和配置，拉伸强度，成本，结构特性和涂料等制造挑战。这些可能包括难以执行的凸起，空白和瞬间，但对于设备的性能可能至关重要。因此，重要的是要确认您的供应商具有此类配置的经验。
As the FDA continues to become more involved in the manufacturing process, it is imperative that the quality inspection methods are correlated between the vendor and customer, and that the customer is educated in the standard tube mechanical properties and functional performance specifics for their device.
3低估或高估需求。合格的公关ospective vendors according to their experience with an application to validate tubing requirements. For instance, small-diameter tubing is becoming more important because medical devices continue to shrink in size. “This requirement creates a need to put more materials or devices through a smaller ID tube,” Heft said. “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, which makes it crucial that the ID is accurate, the inner surface smooth and 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.”
这也会影响物质选择。供应商知识可能是无价的。指出heft：“这很恐怖，但是我们碰巧的是，客户要求316或304不锈钢，然后我们发现他们正在将其用于植入设备。那不是植入级的材料，因此我们向他们建议他们的选择。”
4Don’t take quality correlation for granted. Check for the appropriate quality tests and inspections. A thorough supplier of metal tubes will alert you to potential design problems before they become product problems. They will 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 fabrications can be realistically expected and how far the envelope can be pushed.
Quality credentials may also be important. Many suppliers of medical device components are ISO-9001 certified. But when a vendor has ISO-13485 certification, that credential indicates a supplier has very high quality standards, not only in products, but also systems.
5Turnaround traps. Many suppliers can turn around prototypes in days or a week or two. However, in some cases suppliers take orders without knowing how quickly they can respond, estimating volume deliveries in eight weeks that in reality will take three to six months.
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