The methods behind assessing human factors in medtech are outdated—and they’re due for an upgrade, said Charles Mauro CHFP, of Mauro Usability Science. “The type of research employed to determine if drug delivery devices are usable for the intended patient population is heavily mired in methodology that’s at least 100 years old, which is basic human observation of people interacting with technology combined with the personal opinions of those individuals involved in such studies.”
He describes a typical human factors research lab as follows: Say a team is testing an injector pen. The group will organize a study and use a room that is not much more than a market research room. The team will bring in appropriate respondents (usually those that profile as theoretical patients) to look at several similar drug delivery devices and perform action tasks associated with the device (e.g., injections into a pad). The tasks are followed by preference questions such as, “Which one of two devices do you prefer? Why do you like it better?”
This method is simple observational research and it does have value. However, Mauro said the personal preference questions, in particular, are fraught with problems of inefficiency, personal bias or bias generated by how the moderator asks the questions and, most importantly, an inability to measure actual performance of a device in ways that can be adapted by engineering teams to produce objectively better drug delivery devices. Today too much human factors research is really little more than traditional market research with a task sequence added, Mauro said.