Building the Clinical Risk Perspective into Medical Device Manufacturing

By Thomas Maeder
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The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?

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Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.
Jeff Wickham, P.E. is the Principal at LifeHope Medical, Inc.
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Three Discussions on Bonding a nylon component to an SLA part, First production run of an impeller assembly, and Plastic part with bosses for screws

By Jeff Wickham, P.E.
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Q: I tried to bond a nylon component to an SLA part, but the adhesive easily peeled off of the nylon even though I used what I thought was a very good adhesive. Any recommendations on how to get these parts bonded together? A: Plastics have different characteristics based on whether their material structure is semi-crystalline or amorphous. Plastics are composed of long polymer chains. In an amorphous structure these polymer chains are tangled together like a plate of spaghetti noodles. Typical ex…

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