Challenges related to Home Use Devices
Mike Drues, founder of Vascular Sciences, discusses the unique safety, risk, and usability challenges of medical devices used in non-traditional, home-like environments by laypeople rather than trained professionals. He highlights the difficulty of defining user subgroups for human factors testing, noting that engineers often fail to represent patients with physical or cognitive limitations. Drues argues that risk mitigation should rely on intelligent design rather than labeling, as users rarely read manuals, and emphasizes the need to decouple regulated and consumer functions when assessing combined system risks.