Advances in medical technology are opening up new possibilities within the healthcare domain. Innovations such as home-use drug delivery platforms, connected monitoring technologies, and Artificial Intelligence-driven diagnostic tools are making healthcare economic and accessible; they are creating opportunities for personalised care. However, they also introduce new challenges in terms of how we can test and evaluate new forms of medical technology. How do we make sure that next-generation technologies are safe and fit for purpose given their inherent variety?
Using an example development project where we supported Human Factors Engineering (HFE) for a mobile infusion pump, we’re going to take a look at how HFE is practiced, and consider the approach for new and evolving forms of technology where the system boundary may be broad and fuzzy (e.g. digital and mobile medical technologies).
Our standard process essentially comes down to 3 things:
- Identifying the context in which the device will be used. This includes defining the workflow and conducting a use error/risk analysis.
- Iterative development/formative evaluation. Generating a solution including analytical and empirical approaches for test and evaluation.
- Summative usability evaluation/design validation – providing assurance that a device is safe to use.
Over recent years, we have seen a trend for increasing amounts of attention to be placed on the part of the process that falls under the category of summative usability evaluation (3) and comparatively less attention to other parts of the process. From the perspective of modern technology, it makes more sense to invest efforts in (1) and (2), as the context in which technology is applied is variable and complex.
Identifying the context in which the device will be used
New forms of medical technology are being used in mobile contexts (e.g. body-worn devices). Take the infusion pump example – we are seeing many forms of innovative technology that allow for personal use, mobile use and home use. We are seeing a shift from testing large scale static systems (e.g. volumetric pumps) to smaller portable devices (e.g. ambulatory pumps).
The HFE approach, therefore, needs to take into account the complexities of everyday life of the user, such as how technology is carried around and how it impacts on work life, social interactions, etc. This is hard to do in a simulated context/market research facility because we don’t capture the full range of factors associated with real-world use. In the case of an infusion pump, if the pump is used in a mobile context, then we need to evaluate whether the pump is sufficiently comfortable to allow the users to perform their daily/routine activities (sleeping, walking, shopping, etc.).
We need to evaluate how the technology fits with their lifestyle and how it might impact their relationships. We need to understand more about their condition, needs and attitudes towards the technology so that design can be conducted accordingly. These factors are rarely straight-forward or easy to anticipate. In these cases, a new type of approach is required where we combine elements of facility-based research with elements of contextual study – e.g. contextual inquiry.
Look out next year for our full article on Human Factors – more than simulated use where we will be diving deeper into the three cornerstones of Human Factors Engineering and how they inform design development in the healthcare domain.
Posted by Chris
Principal – Human Factors & Ergonomics, Sector lead Healthcare
The last thing that inspired me: Seeing the London Air Ambulance land.
My dream project: A medical tricorder.
My obsession: Running.
Image credit Stock