Price point is rarely, if ever, synonymous with value, yet it’s not unusual for OEMs in competitive industries like medical and healthcare equipment to base vendor relationships solely on the bottom line. It’s also not unusual for those short-term gains to turn into expensive long-term losses.
Formedical device and equipment manufacturers, there is inherent risk in using commodity injection molders for such critical-use products. On top of risking their reputation by using injection molded plastic parts of lesser quality and functionality, there are stringent regulatory protocols likeISO 7 or ISO 8 clean room和ISO 13485that commodity molders are not certified or equipped to handle.
Compliance — or lack thereof — is an imperative aspect of a commodity molder partnership that medical OEMs need to consider, but it’s not the only one. There are also potential hidden costs that they may have to absorb to correct oversights in the following critical areas:
Design and Engineering
Tight tolerances, sometimes within +/- .001 inches are necessary for proper quality and functionality in complex medical device components. However, consistently achieving them often means making adjustments in the design phase to compensate for the impact of production and assembly processes. With commodity injection molders, you may not have this level of design input, resulting in ill-fitting components or poorly performing devices that require production re-runs or worse, need costly repairs — all of which equates to time and money you can’t afford to waste.
注塑成型Materials
喜欢设计,having little or no control over thesupply chain是商品注塑机的一种非常真实的可能性。这不仅损害了您利用供应商专业知识来简化流程和速度到市场的能力的能力，它还可以危及产品质量。对于医疗器械，必须适当地注意抗微生物表面的专用涂层，或者可以承受频繁处理和用于在医疗环境中消毒的苛刻化学物质的超模制的涂层。所选择的树脂中的任何偏差会增加产品缺陷的风险，并最终是昂贵的保修权利要求。
Secondary Operations
Often, complex medical devices require additional assembly or finishing work like welding, painting or buffering. If done poorly, or without appropriate设计，它可能导致小部件破裂或可能引入壁厚中的不规则，导致短期和长期成分失效。此外，如果您的注塑塑料部件需要多个转换，则由机器安装和额外的处理引起的损坏或缺陷存在非常真实的危险。
Transportation
If your plastic components can’t get to their desired destination on-time and defect-free, there’s no value in a commodity molder partnership. Paying for expedited delivery in addition to product rework to get exactly what you need for your medical device negates any savings that initial low price point suggested.
Intellectual Property Protection
This is particularly important if you choose to partner with an overseas commodity injection molder — you may be unknowingly giving up your legal rights afforded in the United States to registered and trademarked designs and products. Some overseas markets disregard these protections and may produce lesser quality items from plagiarized designs for mass distribution, putting downward pressure on price points — and your company’s long-term profits.
The disparity between price point and the actual cost of the considerable risks that medical device OEMs assume in working with a commodity molder reinforces the true value of partnering with an experienced complex injection molding partner that can contribute scientific molding, engineering/design support, and other expertise to help ensure successful outcomes.
To learn more, read our latest resource specifically for engineering and advanced sourcing professionals:The Ultimate Guide to Medical Parts Manufacturer Selection.Click the button below to access your free copy!
