Paul Charlebois

How procedural observations improve medical device design

I once observed simulated combat first responder training for military medics. I asked the leader (who was a retired army colonel and physician) if their students were making what seemed like basic mistakes to me because they know it isn’t real and therefore aren’t performing at their best. He responded he had seen many times in his career that if they can’t do it in simulation, there was no way they will be able to handle it in real situations. The lesson is: make your devices as usable as possible!

Designing in the medical device industry for about a decade has given me opportunities to see many different types of medical procedures during the development process. Procedural observations of medical procedures are invaluable to the project team. They inform our designs from a perspective of users, procedural workflow and intended use environment.

A project should always begin with a solid foundation of research and information.  Two of the most important aspects are site visits with KOLs (key opinion leaders) and procedural observations of the prospective device in action within its intended environment. This could be OR, ICU or EMS procedures; or simply the devices used by untrained laymen.

I occasionally get the argument that we already have all the information we would ever get from an observation session. Or that any additional information could be obtained from collateral such as watching stored or online videos. While those can be useful as support material for the designer and the broader team, certain types of inputs can only be obtained by observing them first hand.

Good medical device designers remain objective when observing devices being used in their actual environments. I often do not concern myself with the use case of the instrument itself during an observation. It is usually well documented by the product manager or the identified KOLs. What gets overlooked is everything else happening in parallel to the use of the proposed device. ORs, for instance, are a very fluid environment and a lot of instruments will come and go during the lifespan of one procedure. I’ve seen full complex navigation systems appear and disappear from a room during a procedure. This can have a cascading effect on all other devices present in such a confined space.

In one instance, I witnessed damage to important cables due to fast, frequent movement of devices in the space. Even though the client had observed this procedure literally over 100 times, they had not noticed damaged data cables on other devices and had not put significant weight into applying this information to their own instrument. Clinicians care primarily for the patient and the procedure, not the equipment. Understanding and applying this data would result in a better cable design and cable management strategy optimized for the environment in question.

Procedural observations provide designers opportunity to look for areas to add value. We were working on a testing instrument used in the neonate environment. In this case, the act of doing the test was well documented as the device procedure itself was not novel. This allowed me to focus on all of the peripheral activities happening at the same time during the procedure. I noticed that the existing instrument, which weighed about 1.5lbs, would be mounted precariously in a bassinette at an angle that gave the user a good view of the screen. This would often be placed right next to the infant, who often would be almost the same size as the device! A solution from that observation was to have the new device hook itself universally on all bassinettes, giving the user a good screen angle view, freeing up more space in the bassinette and most importantly, keeping it safely away from the baby to avoid crushing it. As a bonus, this also created some IP space in an already competitive market segment.

Most KOL or SME (subject matter experts) interviews are not during procedures and generally only provide statistical, objective procedure information. Often reality is not what you are told over the phone, or see in a video. During an epidural procedure with a clinician tending to the standard operating procedure for application of the drug catheter, we arrived with the patient in a higher level of distress than anticipated.  A totally different approach and process was observed, which was useful to us as our device was informed by a higher level of variability than we would have gotten from interviews and YouTube videos. Understanding such workflows ensures devices impinge them in a minimal fashion while still addressing the primary intended workflow.

Another interesting benefit of seeing real situations is observing how operators behave differently in both real and simulated scenarios. I once observed a circulating nurse trying to set up a simple looking instrument mid-surgery. When designers develop interfaces, they are generally doing so in the comfort of their offices and simulation labs. Neither of those scenarios can entirely emulate what one would encounter in the real world. In this case, we had a dark OR (the use of optics necessitated the house lights to be turned off) with the instrument being setup mid-procedure. The stakes are higher and the operator stress is higher. There was a “cheat card” zap strapped to the instrument but it was hard to read in the dark. All the while the surgeon was demanding that the nurse get the instrument started ASAP because the patient was opened up and setup was increasing the length of the procedure. With all of this in the nurse’s mind, she froze up and couldn’t figure out how to get the instrument set up to the surgeon’s needs. It wasn’t her fault. In fact, she likely had the training and probably had done this set up numerous times before. But the interface was not designed in the dark, nor designed by people who had the mindset that someone’s life was literally at stake while a nurse was setting up the device.

Only real procedural observations give designers the insight to optimize a medical device for the hazard related use scenarios and not impinge procedural workflows.

Image: StarFish Medical

Paul Charlebois is the StarFish Medical Industrial Designer/Human Factors manager.  He welcomes reader comments and often participates in procedural observations of medical procedures during Product Definition and Product Development phases of medical device development.

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