Transcutaneous electrical stimulation (TES) is used to treat chronic constipation in the home environment. Incorrect application of TES may lead to ineffective therapy. We used an application failure mode and effects analysis (AFMEA) to analyze and rank problems. In developing mitigation options to minimize or eliminate failure modes, we identified design and engineering requirements for a new, simple-to-use stimulation system to deliver TES at home for treating chronic constipation, and educational material required to train clinicians, patients, and users. This provided a structured approach to the analysis and design of an improved device for treating chronic constipation.

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