Design for Manufacturing

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Microfluidic Lateral Flow Assay

-An in-field test device capable of measuring radiation levels within blood

-12 component assembly (three of which are over molded) designed for plastic injection molding

-23 fits considered for function and tolerance stack

-Moldflow analysis of the parts for gating, sink, fill, et cetera

-Installation Qualification (IQ) of the tooling and machinery for calibration and consistency

-Operational Qualification (OQ) via process development and Design Of Experiements (DOE) with prototype tooling which proved a real-world check of the Moldflow and pre-tooling analysis that was performed. It was at this point all of the engineering hours poured into the project paid-off with the glaring results of good parts, fits, and assemblies in a fraction of the time compared with punting and hoping for the best.

-First Article Inspection (FAI) samples validating the fit, form, and function of the components

-Process Qualification (PQ) via a plethora of scenario variables validating the robust processing window

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