SMT007 Magazine

SMT-July2018

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38 SMT007 MAGAZINE I JULY 2018 during the design phase to ensure higher qual- ity, higher reliability, lower cost, and faster time to market DFA in the Digital Age While traditional assembly techniques continue to dominate medical device assembly today, the digital age has introduced innovative new options including additive manufactur- ing—or 3D printing—and printed electronics. Both emerging technologies are increasingly helping manufacturers to deliver highly engi- neered and integrated products, and both further underscore the importance of a DFA review. Additive manufacturing can produce parts through a layer-by-layer printing process that eliminates the need for part-specific tooling, or the use of excess materials associated with traditional assembly processes such as machin- ing or molding. As a digital manufacturing process, it allows manufacture of complex parts otherwise difficult or impossible through traditional manufacturing or assembly meth- ods, as well as consolidation of components, streamlined introduction of new products and new possibilities for integrating embed- ded electronics. In short, it unlocks immense design freedoms. Printed electronics is another additive process that focuses on fabrication of electronic devices, components and prod- ucts. It applies novel materi- als to fabricate electronic struc- tures by sequentially depositing layers of materials on top of each other. These structures can be created on a wide vari- ety of substrates such as FR4, flexible polyamide, formable PET or PC, stretchable TPU, flexible glass and even textiles. It enables complex integration of functions using traditional processes like hybrid surface mount and die attach technol- ogy, lamination, forming and injection molding to deliver flexible and conformal form factors. Able to deliver very complex electronic designs, these techniques are being integrated into smart and connected manufacturing concepts and combined with more traditional assembly processes such as surface mount soldering to improve upon solid manufacturing foundations. Smart manufacturing leverages data, network connectivity, business manage- ment platforms, machine sensors and flexible automation to accelerate the collection, visu- alization, communication, analytics and, ulti- mately the agility of manufacturing operations. The digitalization of industry is relevant to the design process as much as the factory floor and has application in a medical device OEM's DFA review. The digital platforms utilized in manufacturing can leverage DFA data and potentially integrate real time feedback of manufacturing events to DfA violations. Such tools also provide a collaborative platform for product and manufacturing teams to work on design evolution in real time. They also enable the integration of artificial intelligence (AI) and machine learning systems to improve the performance of processes like solder paste inspection and optical inspection systems for cosmetic inspection of medical products. This area is ripe for innovation and offers options Figure 4: Nypro's internal smart inhaler project used a fully-functional proof-of-concept to explore how such a connected device would work. Among the questions the team explored was how the features of its inhaler might help or hinder its mass production through a DFA process that involved brainstorming hundreds of design concepts and narrowing them down to approximately ten options offering the lowest risk and cost.

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