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This paper describes the design-for-manufacture (DFM) process for a multi-channel fluorometer product platform. The multi-disciplinary team eliminated the cost of quality by design, using a formal design method, facilitated by Lambda Research Corporation's suite of TraceProTM suite of optical design software. Development of this platform presented rigorous design challenges - from identifying feasible design alternatives to minimizing the exponential cumulative effect of component quality and quantity to optimizing tolerances to thoroughly documenting the design. The design was highly constrained in terms of cost and the ability of the platform to accommodate a breadth of fluorescence-tagged media. Furthermore, the inherently interdisciplinary nature of developing medical devices required a high level of collaboration between scientists and engineers across the areas of optics, mechanics, materials, biology and clinical chemistry. While fluorescence tag technologies enable very sensitive detection of molecules, the anisotropic nature of fluorescence in both intensity and polarization severely complicate system design. TracePro's fluorescence modeling capability enabled adherence to a methodical design process of (1) testing system design alternatives, (2) evaluating off-the- shelf and custom optical component and fluorophore feasibility, and (3) tolerancing for robustness without the cost and time associated with iterative hardware prototyping. |
