Medical Device Usability Engineering, a first-hand perspective | PDD

Medical Device Usability Engineering, a first-hand perspective


on February 12 2013

I’ve only been at PDD a matter of months as a Human Factors and Usability consultant, but to say that my feet have barely touched the ground, would be an understatement. I’ve travelled to four different countries, and observed 100 participants. In this article, I take a look at why going into the field is so important in identifying device development opportunities…

Although I already had industry experience moderating many UK based medical device usability studies, I only had 2 non-UK studies under my belt. How that was to change, in my first 3 months at PDD I’ve had the opportunity to moderate and be involved with studies for medical device and pharmaceutical companies in Melbourne, Australia; Sao Paulo, Brazil; Zurich, Switzerland; Seattle and Boston in the USA.
Above and featured image credit: UFV, via Flickr

Usability studies fit into a broader Usability Engineering process which is intended to meet regulatory expectations as well as to build intrinsic usability into medical device designs. This is another opportunity that I’m relishing at the moment, taking my industry experience and modifying it to match my own interpretation of officially recognised device-specific and general standards published by national and international standards bodies. There are even the opportunities to apply scaled-back versions of the medically-focused process to product development projects in other sectors. This variety keeps things interesting and brings a new perspective for subsequent medical device projects.
The international travel was really refreshing and a great experience. It allowed me to observe cross-cultural differences first-hand with regards to concept preference between patient populations in Melbourne, Sao Paulo and Zurich. This was a particular highlight because a lot of the time you are limited to the theory and perhaps, due to time and money constraints, have to pick a single population to act as a “good indicator” for usability across multiple markets. This time, I got to do it for real!
The travel also made it practicable to invite a client to attend usability studies in Seattle and Boston. This proved to be very insightful for them, as it was for me, since we observed new use-related hazards that simply could not be detected using earlier analytical approaches, reinforcing the value of such exploratory research.
Image credit: PDD, examples of simulated use environments used for moderating usability studies.

One example was a gravity-fed prototype device that relied upon remaining horizontal and was positioned by users perpendicular to initial expectation, which caused the device to sit at an angle approximately 30 degrees off horizontal. Furthermore, it transpired that the closest AC wall sockets to hospital beds are typically reserved for equipment and devices that are most critical in supporting life; since the prototype device did not carry this level of priority the power cord may need to reach further than expected, possibly requiring additional length.
Although sometimes they may seem small, these examples are why I truly believe there is no substitute for getting out of the office and observing real users when it comes to medical device design. The insight is invaluable. There is of course a time and a place for desk research but you will always see something you didn’t expect when you ask real users to explore a device in actual or simulated use environments. Aside from that, it’s fun and rewarding, especially when you know the data you’ve captured will inform vital design decisions to mitigate use-related hazards and establish effectiveness, efficiency, ease of user learning and user satisfaction.