I’m blogging about a blog that struck me after seeing exhibits and poster sessions at last week’s mHealth Summit. Laurie Reed, an engineer at The Farm, a medical device design and consulting firm, was my inspiration. In her recent Farm Blog, she emphasized the importance of human factors in the rise of mobile health.
Laurie cautions us that the “implementation of human factors engineering throughout the design process will be critical for emerging mobile health applications . . . because it’s good practice and is an essential tool for decreasing patient safety risks while increasing usability and effectiveness.” Oh, yeah, and the FDA cares about this, too.
Way to go, Laurie! My “universal” remote control for the TV in our home is a mobile device. It was not designed with a normal human in mind. After three years, I still have to use a visual cheat sheet created by my hubby to switch from cable to a DVD. Although I could die of a heart attack from frustration with this “should be easy” device, my life is not dependent on it to monitor, measure, or diagnose my health. Mobile health devices, including apps, are quite another matter.
Laurie reminds product design teams that “human factors is not a one-time testing event that occurs at the end of the development cycle.” Done correctly, it is an iterative process that “starts with the gathering of user requirements” and includes testing of multiple design concepts, design verification, and a summative validation.
Oh yes, and thank you Laurie for reminding readers to use our standards in this design process, including IEC 62366:2007 and ANSI/AAMI HE75:2009. A book to help guide newbies through the human factors process, Handbook of Human Factors in Medical Device Design, is available for purchase at the AAMI Marketplace.
To read Laurie’s full blog post, click on this link.