User engagement studies help medical device manufacturers understand friction points as the medical device enters the point of use. However, in order to have well-developed study’s medical device manufacturers also need to imagine how the product may be misused during the journey to the point of care. One example that I talk about on my podcast is the ambulance driver that utilizes his teeth to open a sterile pack. Obviously, this contamination point was not imagined or addressed for this emergency use sterile device. Based on my discussion with Dr. Carole Barnum PhD with the UXFIRM, UX study’s do not address this type of misuse as it is out of scope for such a study.

In order to truly understand how a medical device may fall victim of a prevailing misuse issues, medical device manufacturers would need to conduct an ethnographic research plan in order to understand all contributors to handling and use failures. A trained observer would need to monitor all touch points for the device, from cradle to grave, but sadly because such a study would be exceedingly costly for most medical device manufacturers these studies are rarely if ever conducted.

Our company Van der Stähl Scientific provides packaging machinery to medical device manufacturers to seal their devices in pouches that will be offered up sterile at the point of care. These machines that we offer have a host of safety systems such as proximity sensors and emergency stops. As developers of this type of equipment it is our responsibility to imagine all potential points of harm. These may include things like the 2 o’clock in the morning $10 double dog dare from one operator to the another to put their finger in the sealing Jaws. This is why medical device manufacturers and even the medical device packaging machine makers have made an expanded move into this new era of “worst case scenario” evaluation.

Frank Zappa said “Some scientists claim that hydrogen, because it is so plentiful, is the basic building block of the universe. I dispute that. I say there is more stupidity than hydrogen, and that is the basic building block of the universe.” Now, I’m not going to go on record here reporting that the bulk of humankind is stupid, but I will say that we should perhaps develop our devices as if that statement is true. Recently one of my employees assembled racks for our laboratory completely inside out and backwards. When I performed a post-Mortem on this event the root cause was clear, the instructions were good, but they were not great, great would have made the difference. The manufacture failed to imagine the host of human intellects and thinking algorithms that would engage with their product and their instructions.

Understanding your packaged medical devices journey to the point of care may mean becoming more granular about the datum that is collected. It may mean opening yourself up to exotic possibilities on how the device may be misused. It also may mean bridging the gap between how you believe the users will interface with your device and how they actually will. In short remember, Eyes wide open and expect the unexpected…

For a more expansive discussion on user study’s, I would encourage you to have a listen to our podcast SPOT Radio where I have a very edifying discussion with Dr. Carole Barnum of the UX Firm www.spotradiopodcast.com