SMT007 Magazine

SMT-July2018

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36 SMT007 MAGAZINE I JULY 2018 manufacturers can achieve further benefits in the overall quality, reliability, time to market, cost and—most importantly—the efficacy of their medical device. But what factors determine the best method of assembly? How, for example, do you choose between a manual, semi-automatic, fully auto- matic and flexible automation solution upfront when your device will go through rapid prod- uct refresh cycles? One way to optimize both the design of a device and the efficiency of its assembly process is to employ design for X (DFX) review tools. Whether focused on manufacturabil- ity (DFM) or assembly (DFA), utilizing these design tools early in the product development process can anticipate and avoid many barri- ers to efficiency and performance, and achieve faster time to market. A medical device designer, for example, may have a very clear vision of a product's end requirements. But they may have overlooked common issues that arise during the interme- diate assembly phase, where there are often potential trade-offs to consider, such as the comparatively higher assembly and testing costs for a medical device that must reliably deliver over a million hours of service. A design for assembly (DFA) approach antic- ipates these questions and prioritizes assem- bly methods and costs accordingly within the overall product development cycle. A typical DFA process might consider, for example, the percentage of parts standardized across differ- ent assemblies, part count consolidation and modularity, minimization of handling and cycle times, standardization of gripping meth- ods and opportunities to reduce post assem- bly processes. The DFA process also seeks to minimize the time it takes to operation- alize product assembly, and to ensure that supplier maturity will remain consistent over the period of development. Another impor- tant input of the DFA process is support for other DFX guidelines as part of continuous improvement. Ultimately, DFA should help to reduce throughput time, control assem - bly costs, enhance safety for operators, and ensure a design meets all specification, qual- ity and reliability targets at an acceptable product cost. Options Need Not Overwhelm Depending on product requirements and design, assembly can be as simple as mechan- ically snapping components together or as complex as using functional integration like adhesives, welding or riveting. Product managers also must often choose between manually assembling devices vs Figure 2: The design and functionality of medical devices is not the only thing growing more complex. Various global reimbursement policies and regulatory approval processes are also putting more demands on how these devices are assembled.

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