A blog on medical devices, biotechnology, bioengineering, healthcare, etc. Join me on discussions about devices, regulations, the FDA, policies, law, and what not! Chaaraka is take on Charaka, an ancient Indian Physician of lore...
Tuesday, January 09, 2018
Simple Usability Problems that medical device companies fail to resolve and why - an example
So today, I will tell you a story. In a galaxy not so far away, I visited a medical device company, where nepotism, hubris and a "we are always right" are fostered and promoted. The result is of course, disastrously bad medical devices, but because the customers know no better, they continue to stay in business. One of those odd, disgusting things no one can fully explain...
To set the stage further, they have a device that does a number of things, for a meaningless endpoint to help, lets say vain people who'll pay anything to think they'd look better.
Among the things it does, let's say there is a "heater" that heats by passing fluid. So, you have to connect this fluid element that flows from one subsystem of this raving madness of complexity to another. Along with it, are other connections for signals, grounding and a variety of "thingamaboobs", all part of the grand act of impressing the gullible.
Now, they use one portion of the device to test the other. They ensure that the connection is made, the heating element is connected and so on.
When the grounding connection between the two device subsystems fails, an error is generated. This is how the system addresses the error:
1. The visual display shows an image of the heating element prominently, with the grounding element lurking somewhere in the background.
2. The text display reads out that it is indeed the grounding element that has failed.
Many of the assemblers and testers at this organization tend to see the heating element fail, and conclude that it is the heating element that has failed when other culprits lurk in the background.
Until each individual is told to "read the message" and "ignore the image" to get to the specific cause, they stop said testing and blame it on the heating element.
Work stoppage, frustration, being talked down to, and all around perplexity ensue!
See, the problem is that the image is essentially incorrect, and the text clarifies the actual cause of error for you!!
Imagine walking around with your shoe laces untied, and being shown a picture of a nose with a booger hanging out with the shoe laces somewhere in the background, completely out of focus!
USABILITY and why this is a problem for so many medical device companies
1. Usability is an after thought for such organizations. Devices that are incredibly cumbersome to use are quite common in the field. This is, but one clear example of a group of people ignorant of usability, also ignoring it.
User manuals are published grudgingly, just to meet the regulatory guidelines, and then, completely ignored. Same goes for the assignment of error codes, explanations and visual examples. With that attitude, you will never develop a more usable device. You have to knock the socks off regulatory requirements, not whine and complain about them, given that most of these requirements themselves, leave much to be desired. Otherwise, of course, there are other job opportunities for people with attitude issues. But, yay, groupthink!
2. If you have managed to confuse your own people, how do you expect complete strangers to do it? This is mainly because the people who design such problematic systems express unwarranted arrogance about their ability to design products.
People learn differently. Some people like visual messages, and give them a preference. Others do better on text. Honestly, this is why you have at least these two, if not an audio read out of the error. Usually, you use tones to do that. Onto that point, these messages need to be coherent and get to the point. Telling someone, "don't just look at the picture, read the text", should get you fired, technically.
3. You may have used the device you designed yourself (hopefully!) but it is not enough. You need to be aware of how others are perceiving your devices, how they are using it and what issues they encounter when using it. Your own assemblers and testers might be the best place to get started. You should also see what your sales people are doing. Go talk to the end users. Get their permission (and incentivize them) to shoot videos of them using your stuff, ask them about the problems they run into - basically be data driven! Sounds like commonsense, right? You'd be surprised.
4. It takes a village...for everything! If you outsource your design, or the usability portion of it, and then ignore these people in the data collection and feedback loop, well then you are going to have issues. This is one of the biggest problems with contract manufacturing (blog posts later this year on this stuff). You need everyone in the design chain to be involved in collecting and using data on how usable your devices are.
5. Have you really studied and understood usability? It is not simply about making connections between subsystems, or making sure the ground pad is appropriately positioned on the patient. Devices are never perfect and all kinds of error conditions pop up. It is important to communicate error conditions, and the appropriate remedy for those conditions. Otherwise you run the risk of patient injury or death! A lot of people who should not be making key design decisions without a class or two in usability for healthcare, are out there, making decisions!
These are but some thoughts on why so many medical devices are not usable. There are more, and as I encounter them, I will lay them out. It is sufficient to say that there are some devices out there, with alarming issues, and it takes the right kind of education, experience, humility and curiosity to design usable medical devices, as much as anything else usable!
1. Image, Courtesy Pexels: https://www.pexels.com/photo/clinic-doctor-health-hospital-4154/
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Posted by Srihari Yamanoor at 7:12 PM
Labels: communication, customers, design attitudes, error codes, error prevention, errors, Medical Device Design, medical devices, observation, surveys, text communication, usability, users, visual communication
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