Company insight
– provides a cost-effective baseline and is comparatively straightforward, as most manufacturers will have access to performance test capacity in-house or through sub-contractors, and since test parts may be easily procured from a service bureau running FIM.
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Part needs to be biocompatible: Biocompatibility is another requirement that may steer device developers toward specific groups of materials, which have been tested according to ISO 10993 or a similar standard. The biocompatibility of the finished medical device will depend on the manufacturing methods involved, as in-process contamination or degradation may change the behaviour of an otherwise biocompatible material. To support developers needing biocompatible parts for pre-clinical testing, Addifab has developed a protocol that demonstrates unchanged chemistry and verifies that no toxic substances are present on parts after processing with FIM.
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Part needs to be sterilised: The chosen method of sterilisation may have significant impact on the choice of materials and manufacturers may want early assurance that parts may be adequately sterilised and that they will meet other design input requirements after sterilisation.
The protocol that Addifab has developed for biocompatibility assessment is useful also for assessing whether the baseline behaviour of a part has been changed after sterilisation, while access to small
quantities of injection- moulded test parts will allow early assurance testing to be done at a development stage where budgets for conventional metal tooling may not have been released.
Verification of quality is not only a way for businesses to excel, it is seen as a vital necessity in many jurisdictions.
Crucial early assurance testing The three exemplary use cases listed above may be built into a test framework. A framework such as this will help project management assess the scope of verification activities, to support the planning, budgeting and prioritisation of early assurance testing and first-part verification, and balance these activities against test activities that may only be performed after investments in injection mould tooling.
Why invest in early assurance? The verification of a medical device is a
process that starts with the definition of the first design input and ends with a released device. Throughout the development process, device developers need to constantly balance the resources spent on verification activities against the expected benefits in terms of increased certainty that the device will perform as intended.
The use of FIM to perform early assurance testing on injection- moulded components will involve the investment of project resources and needs to be prioritised against other activities. In that context, it is worth keeping in mind the general rule that errors are cheaper to correct the earlier they are caught. Errors involving injection- moulded parts that are made with metal tooling are among the most costly and time-consuming to fix. By implementing FIM, project managers may start developing assurances that a given design is on track to meet design input requirements long before investments in metal tooling need to be considered. With the added confidence that design flaws identified early in the process will be much quicker and cheaper to correct, compared with those that end up triggering the rework of metal tooling. ●
Errors that are revealed by Freeform Injection Molding are nowhere near as costly as errors in conventional metal tooling.
Medical Device Developments /
www.nsmedicaldevices.com
www.addifab.com 37
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