Micro-sized components are often the key enabling elements of Class II or Class III medical devices and drug delivery devices, and because of their size, they often require micron-level tolerances. With 30 years’ experience in micro injection molding, Donna Bibber of Isometric Micro Molding has developed a best-practice risk assessment strategy called “Microns MatterTM”, which is used for the development and high-volume production of critical-to-function micro molded devices.
This White Paper outlines a Microns MatterTM case study, designed as a quick reference tool for companies attempting to develop and validate micro molded components and devices. It focuses on a Class III micro molded device with 16-micron tolerances.
The Microns MatterTM process follows a Japanese-like strategy — essentially “plan, plan, plan, execute”. The axiom “fail to plan, plan to fail” is never more accurate than when applied to micro manufacturing projects. But failure of planning, and resultant re-iterations of designs, re-assessment of manufacturing protocols, and adjustment or reworking of tooling are not just annoying, they are sometimes catastrophic in respect of time and cost and can be the difference between project success and project failure. Measure twice, cut once!!
Micro molded parts are often the size of a fingerprint crease, so they require minimal tool steel cutting time compared with macro sized parts. Because of this, a disproportionate emphasis needs to be placed on the “planning, planning, and planning” of the setup of critical equipment required to make an accurate micro part or component in a timely and cost-effective fashion.
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