Tiny Medical Devices – Designing for Success (part 2)
Tiny Medical Devices – Designing for Success (part 2) VALIDATION Picture this – your medical device is designed and you’re ready to validate the tiniest component – the technology piece that enables your intellectual property. You dive in headfirst, knowing your part has +/- 5 micron tolerances on a plastic part. You start like any engineer would start – with a solid stack-up tolerance plan and <20% gage R&R – you should be fine, right? Consider this general micro molding rule of thumb – BEFORE you even design the injection mold. If you work backward with the numbers, you’ll have ~0.0004” total tolerance Total 10 microns = (0.000397”) Tooling = 20% of 10 microns = 0.00008” (wow, really? This is difficult to do but SO critical to hitting the final…





