Jonathan Bainbridge, Senior Human Factors Consultant at Team Consulting, shares his experience of working in human factors and medical device usability. Jonathan was interviewed by the University of Derby as part of a podcast series. The podcast aims to give students on the university’s Human Factors and Ergonomics degree courses insights into the healthcare sector.
In 2011, the FDA in the US issued draft guidance which outlined the human factors activities that should be conducted during product development. While many manufacturers know that human factors activities need to be conducted, some still do not perform such activities early enough or do not perform enough of them.
I have often worked on projects where human factors has not been sufficiently considered during the product development process. This means that we, as device designers, come across critical usability issues late in the process where users cannot use the product as the manufacturer intended.
The main issue is that making changes this late during medical device development can potentially cost a lot of money and delay the overall project programme. But if safety is compromised, the manufacturer will have to make those changes if the regulators agree that it can lead to the product being used safely and effectively by its intended users, for its intended uses and that it can be marketed.
Therefore, human factors should be a design activity and not just a compliance one. It’s a discipline that needs to be embedded in the design process as early as possible just like other disciplines within the overall project management. Only then can the real value of human factors be unlocked and the benefits in terms of patient safety and usability be realised.
In the medical devices sector, human factors is all about managing use-related risk. We need to demonstrate that risks have been managed and mitigated throughout. To do this, we go through a process of defining the tasks that users will undertake: use-related hazards, errors they might make along the way, what harms might occur and how bad they are going to be. We then implement appropriate risk control measures so that those things cannot occur, or at least the impact is lessened.
But all too often we see products that have been designed without following this process. So instead of mitigating risk through design (i.e. you’re designing out the opportunity for the harm to occur by designing the product appropriately), all we can do is create instructions or add labels to inform users about the risk.
Further improvements may entail costly changes to the physical design of the product. Therefore, not mitigating use-related risk appropriately could mean that patients cannot use your product safely and effectively and ultimately, the regulators will not approve it.
Shortly after all our user studies, we provide our clients with an informal summary of the results. We then follow-up with a more formal report a few weeks later. While the formal report can be an essential part of the product documentation, a report is no substitute for the design team seeing real patients using their product for themselves.
No matter how well-designed you think your product is, users will always do something unexpected. They may use a device in a way that the design team did not anticipate.
Being able to see that in person can be invaluable, as it helps us gain a full understanding of interactions between patient and product. It communicates the issues much better than a written report ever could.
Generic devices can be a more affordable solution for both patients and healthcare providers. The objective is to make the generic device substitutable for the original device without the intervention of a healthcare provider or additional training, with the pharmacist switching to a generic device when dispensing drugs.
For example, if a patient has been using their inhaler for a few years but are given a different one containing a generic drug when collecting their new prescription, the generic may not function in the same way as the original. If the patient isn’t given any new training on how to use the generic, they simply go home and continue their treatment as normal which can lead to use error.
The challenge from a human factors perspective is making the generic device at least as usable as the original one while not infringing design rights or introducing new opportunities for user error and patient safety hazards.
Connected devices are becoming increasingly prevalent and have a number of benefits for users. For example, a connected inhaler may be able to provide data on the user’s inhalation profile, such as how well they are inhaling the drug, or alert users with reminders to take their medication. Because mobile phones can track weather and pollution levels, users might also be able to see when they last had severe symptoms and correlate it to the level of air quality that day.
Some connected medical devices are designed from scratch with integrated sensors, while in others the connected module is provided separately and the user needs to attach it to the device. In all instances, the combination of a device and a connected element introduces human factors challenges: there is both a physical device and the connected element to consider. Sometimes, the mobile app itself is considered a medical device, in which case there are also some regulatory aspects that need to be addressed.
I believe that in all areas of life, connected technology is likely to play an ever-greater role in patient healthcare in years to come.
There are numerous benefits of medical device connectivity for the healthcare provider of course, but it must provide an actual benefit to the patient as well, rather than just adding technology for the sake of it.
If not done right, the product becomes more complex and can add burden to its use.
We still have quite a way to go in raising the profile of human factors and getting the message across that it is a design activity and not just a compliance activity. Human factors is not simply a tick box exercise that you perform at the end of product development.
I also think many people still believe that human factors is all about performing user studies. While user studies are an integral part of the overall process and are an invaluable tool, there’s so much more to the human factors process. For example, many of the human factors activities we do at Team Consulting are desk-based activities – we can inform the design process without the expense of a study. Human factors experts know a lot about user characteristics and their capabilities. We can analyse use related risks and offer expert advice on concepts early in the design process before a physical product really exists.
We do not need user studies to start a process, but as mentioned, getting the manufacturer’s design team to see real users attempting to use a product is still, for me, the best way to get them to engage and highlight the importance of human factors and user input.
This blog is based on a podcast recorded for the University of Derby: Ergonomics and the Human Factors with host Jay Lawrence. Listen to the full podcast here.
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