The last decade has witnessed an onslaught of home-based technology, from smartphones with their integrated cameras, apps, and wireless communications to voice-activated web appliances like Amazon’s Alexa and Google’s Home providing wirelessly monitored control of nearly anything we can imagine. While this has been wonderful for consumer convenience, it is also enabling at-home patients to do much more to support their health thanks to this new digital age. Along with advancing vital signs monitoring, patients can collect their own samples for lab analysis and perform diagnostic tests and therapies, including bolus drug dosing to continuous monitoring and real-time optimized delivery with wearable devices. This sector of the industry is growing so precipitously, FDA felt a need to create a new classification of medical products known as Combination Devices.
This article highlights the benefits of rigorously integrating usability design into the development of patient or layperson-operated combination devices used in home-based healthcare.