Last week I was able to visit ArjoHuntleigh, a huge medical technology company that develops hospital solutions such as hospital beds, medical baths, and ceiling lifts to transfer patients within hospitals. They have an office in Malmö where I was able to meet with Kristina, who works in strategic marketing and clinical affairs, and Emma, who works on product development and validating ArjoHuntleigh products with end users.
Patient lifters – aids to get patients in and out of bed, stand up or sit down, and move through hospitals – are mostly developed by Scandinavian companies, Kristina said. She thinks this is tied to Scandinavia’s tradition of ergonomic design for the comfort of the end user. ArjoHuntleigh employs many user-focused design techniques both when identifying a need and when developing a product.
ArjoHuntleigh is currently working on a project to identify customer needs for long-term care (elderly patients). They have teamed up with ReD Associates, a Danish company that does ethnographic studies. ReD is currently studying 30 individuals each in Japan, France, Canada, and the US, following them every single day for weeks at a time. As these elderly individuals wake up, use the bathroom, and get into bed to sleep, ReD takes note of their behaviors. Kristina mentioned that the goal of the study is not simply to see what technology can assist an elderly person to get out of their bed, but to see them in a more holistic way. How much time do they sit in a wheelchair? How do they manage having nothing to do for most of the day?
While this ethnographic study method is extensive and probably expensive as well, it reveals far more of the truth than yes-or-no questionnaires. As Kristina mentioned, “If I ask you, how often do you brush your teeth? When during the day? For how long?…You would probably answer one way. Then if I follow you, I would see that you don’t really do that. We do so many things that we aren’t aware of.” ReD Associates tries to dig deep and understand people’s reasons for doing things. When they see an elderly person performing a certain action, they’ll ask why that person is doing the action. Then they will ask why again in response. At this point, Kristina said, she starts to think “oh, you have got the answer now. But they just keep on asking why, a little bit annoying almost, but in the end they actually get much more information than I would have gotten. Because I would have stopped earlier.” These interviews, plus hours of film and tons of pictures, add up to a lot of useful information as ArjoHuntleigh considers customer needs.
I asked about the other ways that ArjoHuntleigh identifies gaps in healthcare when designing a new product. Kristina told me that the company has been around long enough that they get complaints and suggestions from customers. “But it’s a bit tricky,” added Emma, “because sometimes the caregivers say they would need this kind of thing to make the workflow work. But for us, it’s important to actually look at the workflow and understand the gap. Sometimes you don’t see, yourself as a caregiver, that if you did the thing in a different order, it would be easier.” Sometimes, the right solution isn’t a product but rather a change in workflow or a different approach altogether. As Kristina said, “We need to focus on the problem and identify the problem without talking about the solution.”
Emma works on a later stage in the process, after a product has already been designed. At this point, ArjoHuntleigh still gathers lots of information. The company pays caregivers to come in and use the products, and these sessions are always filmed for later analysis. Often, ArjoHuntleigh will provide little to no instruction to see how the caregiver approaches the product and if the design is intuitive.
ArjoHuntleigh works with caregivers at this stage for two reasons. One is simply that it makes sense; caregivers will be the ones operating the technology for the patients at hospitals, and they have an intimate view of what is most needed and how the patients suffer day-to-day. But the second reason is that ArjoHuntleigh is not allowed to use “real patients” at this stage. For safety, legal, and privacy reasons, sick and injured patients are not allowed to test medical products that are in development.
Of course, this sounds obvious, but it’s something I haven’t thought much about. Now, I think it is the biggest challenge that medical technology companies must face, especially those that design for hospitals. While ArjoHuntleigh can ask unhealthy patients what they want through questionnaires and send pictures of potential products, that’s not the same as seeing someone work with the device and seeing if it is intuitive. However, when developing a smartphone app for something non-medical, you can do test work with the target population at all stages of development. I suppose everything must be slower and handled more carefully with healthcare.
Emma and Kristina described this further: “The problem we have with medical devices, and that’s the same in all the medical device industry…if you have a walking frame or something, you can’t test it on a real patient until it’s finalized and CE-marked. That is frustrating, actually, it is very frustrating that…we need to have acting patients, and in some research institutes they actually have professional ‘patients,’ people who pretend to have pain. But that is a challenge, I think. You can of course go out and see how they work with the products we have today and if they would work with a competitor, but you can’t bring in a prototype and ask them. It’s the legal legislation.” They are only allowed to use healthy volunteers until a product is CE-marked. You may have seen a CE marking on a product before; it’s the “manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation” (http://www.ce-marking.org/what-is-ce-marking.html).
Emma explained that once a product is quite far along in its development – and this is where her work is focused – it can get temporarily CE-marked. At that point, the final stage of testing is to introduce the product into the real market, lending it to a hospital with real, unhealthy patients. This is the “customer acceptance phase,” after ArjoHuntleigh has mostly finished the product and applied for CE marking but might make final tweaks. “For example,” Emma told me, “we tested a sling for a month in Holland in a hospital at two units, and we left the products there [for a bit]. And you have to supervise everything. If anything could go wrong, you just have to stop the study. Then they use the product in the intended environment with real patients. You send the sling to laundry and back again, for example, and you use it with all their products, which is very good for us because that’s the first time you realize, for example, ‘oh there’s going to be a lot of blood on the sling, is that going to be cleaned correctly in the washing procedure?’ I mean, those things you can test and verify here with a bit of blood, etc. But you wouldn’t imagine that it would be certain temperatures or that they use bleach,” for example. If everything goes well after 2 weeks or so, ArjoHuntleigh takes back the product and finalizes the CE marking. At that point, it is finally ready to be deployed. This phase is key to ArjoHuntleigh’s design process, as there’s always one more thing they haven’t thought of in the final environment.
Another design challenge that ArjoHuntleigh faces is its global market. ArjoHuntleigh creates products for multiple countries, all of which have different regulations for safety products. So even when a product is finalized and CE-marked in one country, ArjoHuntleigh might need to make a different version for another country.
Kristina explained that products designed for US markets need to have more extensive manuals and warnings than those designed for European countries. She suggested that this “culture of safety” may have resulted from the ability to sue people, which I think is a fascinating argument. Basically, because Americans can sue other people or companies for huge sums of money, companies do their best to minimize liabilities. So US companies become very wary of people who might want to sue them, and thus put up lots of rules and disclaimers so that they are not liable if something goes wrong. Kristina described a time when she was at a pool in the US, and the lifeguards blew their whistles at her because her child wasn’t following some rule. It makes sense that pools have all of these rules in the US – they might get sued if something happens to any of the swimmers, and they should be able to point to a user failure to follow rules rather than a negligence on their part. But “in Sweden, there would be zero” lifeguards. People are responsible for themselves and for their children, and they blame companies or organizations less quickly for what might be their own failures. This difference, suggests Kristina, is perhaps why the medical device regulations in Sweden require fewer warnings in the manuals.
I think there is a lot of truth to this, but it was not intuitive for me. Since Sweden has a more socialist government than the US, I figured that there would be more oversight, more regulations, and more rules here than at home. But perhaps this Swedish sense of individual responsibility has nothing to do with the government. “If you are causing an accident or someone thinks that you are not driving carefully,” said Kristina, “that’s the problem. If it’s the radio, or the kids playing, or if it’s the computer next to you, or the phone – it doesn’t matter. It’s not the phone. It’s you.” According to Kristina, suing someone in Sweden is not usually a lucrative experience, and is difficult and time-consuming; so people just don’t do it very often. It wouldn’t surprise me if there were many more lawsuits in the US as a result of our capitalist nature and a desire to fight for monetary gain when there is a chance to do so.
I never expected a cultural difference in attitudes towards money to have an impact on healthcare, even in a small, indirect way. But that’s what this project is all about – how all these external factors might influence differences in the field of medical technology in different countries.