Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
Why Failure Mode Identification is Preferred to Identifying Every Conceivable Use-Error
A Failure Mode is defined as “the manner in which a device (equipment, software, etc.) may fail functionally.” Depending upon the complexity of a device, there may be many conceivable use-errors for every failure mode, not all of which may be observed in usability testing and thus not necessarily required to be identified in a UFMEA. With complex devices where it is essential to prioritize use-steps for evaluation, rather than spending time conceiving of every possible misuse/use-error for a product, identification of primary failure modes associated with use-steps will identify those use-steps that are critical and/or essential for safe and effective product use by end-users (i.e. failure modes resulting in higher severity of harm ratings, independent of probability of occurrence, or impacting on intended product treatment, whether or not diminished/over- treatment may result in harm to the patient).
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Posted on Oct 24, 2013
Mobile Health Apps: The Intersection Between Innovation and Regulation
If it detects heart rhythm abnormalities, your iPhone is an ECG, says the FDA.
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Posted on Oct 07, 2013