Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
Medical Device Usability: New Human Factors Standard HE-75
Ximedica recently hosted an event dedicated to the discussion of HE-75, the latest FDA human factors standard for the design of medical devices. It was co-sponsored by the IDSA Rhode Island and IDSA Medical Section. Led by Steve Wilcox, PhD, of Design Science, and Michael Wiklund of Wiklund Research and Design, both members of the committee that developed the standard and contributing authors to the HE-75 content, the review was well attended by a range of product development specialists.
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Posted on Jul 23, 2010
Do Medical Device Design Reviews Present a Moral Hazard? (Part I)
I recently came across an intriguing discussion thread on the medical device engineers network on LinkedIn. Someone asked whether the design review--a required element in FDA regulations on design control--creates a moral hazard in the device development process. The discussion was sparked by an essay written by technologist Les Bogdanowicz, and can be found on his LinkedIn profile. In the discussion, commentators deliberated the obvious increase in medical device recalls over the past few years. The FDA design review process was originally intented to decrease the number of product recalls, but sometimes what seems like a good solution can in fact have unintended consequences.
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Posted on Jul 01, 2010