During recent usability testing of an updated medical device, I was reminded how important it is to set realistic expectations of medical device users when designing a product. Since the end users are the experts at what they do, it’s easy to think of them as having super-human abilities to foresee safety hazards or creatively troubleshoot device issues. While device users often surprise us with their perceptiveness and ingenuity, we need to remember that they have limitations like the rest of us. Designing medical devices should involve anticipation of and compensation for as many of these limitations as possible so that users can interact as safely and effectively as possible with the final devices.

So what are some things device manufacturers can do to make it easier on the end users? HE75:2009 gives us a good reality check in the following areas:

  • Don’t rely on training. Medical devices should be designed for intuitive use because despite the good intentions of the device manufacturer, institutional policies, or the end users themselves, many users do not receive the proper training before they operate a device. In a clinical environment, training is often passed along from user to user like a game of telephone so that one user may receive a different version than another.
  • Don’t rely on instructions for use. If certain information is only found in written form, users may overlook this if they favor a more hands-on approach to learning, such as an in-service demonstration. Device instructions are often discarded, misplaced, or hard to find when needed, and users may be too busy to read or even skim a complicated manual.
  • Don’t rely on warnings. Warnings, as part of instructional documents or the device user interface, can be indications of design flaws. Identification of safety and usability issues late in the design process are often more difficult to correct, resulting in a heavy reliance on warnings as risk mitigations. Too many warnings can give users “warning fatigue” which may cause them to subconsciously downplay the importance of each individual warning.
  • Don’t rely on users’ memory. Medical device users are frequently very busy, sometimes with multiple tasks at once, and can easily become distracted or forget to perform a certain task. The more the device can do to remind users of important tasks or information, the less chance the users will forget.
  • Avoid information overload. It’s easy to provide more information to the users than they really need, which forces them to filter and prioritize this information as part of their interaction with the device. Simplifying displayed information and emphasizing certain key points, while providing clear access to more granular or detailed secondary information as needed can help minimize the human information processing burden.
  • Don’t assign users tasks that are better suited to the device. Automating tasks that the device can perform more efficiently or accurately than a human operator can save the end users a great deal of time and effort. The reverse holds true as well – if a human can perform a particular function more effectively, that function should be given to the device user. The ability to respond to emergencies should always be considered carefully when assigning tasks.

These tips from HE75 are certainly not saying that training, instructional documents, and warnings cannot be good tools or effective risk mitigations. Rather, they are a reminder that these things shouldn’t be relied upon too heavily – there really is no substitute for an intuitively designed medical device!

-KB

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!