Applied Ergonomics Paper: It’s All About Communication: Christopher Vincent, Yunqiu Li, Ann Blandford
When it comes to the design of medical technology, going it alone is rarely an option. Getting a product onto market requires people in different professions working together. Medical infusion devices such as pumps provide a case in point. They are used to deliver a wide range of drugs and fluids to patients, and therefore need mixed professional teams to think about how equipment will be used, as well as what is possible in terms of making it. For example, clinicians can give advice on what patients will need from the devices, engineers can tell us what is technically possible and ergonomists tell us how the end-product will fit with the needs of the user and wider organisation (e.g. hospital). One of the challenges is that products may be used in a variety of circumstances, for example users may include patients, nurses, anaesthetists and/or medical engineering staff. The products may be used at home, on a hospital ward or in an operating theatre.
So different people need to pool their expertise early in the design process.
In principle we should be able to communicate with each other so that we can work well together but, in practice, studies in other industries would suggest that we don’t always get it right. For example, personal and professional differences can get in the way, organisations might not be structured to make it easy for people to work with colleagues in other departments, technical jargon confuses, there are stereotypes, internal politics and a host of other barriers. These barriers are not in the best interest of either the customer or the manufacturing organisation. The end result is that the solution doesn’t match the needs of the user, takes longer to deliver or costs more than is necessary. We need to get better at letting people talk to each other, but we don’t always know how.
We interviewed people working in a range of medical device companies and consultancies and found that barriers to communication were recurrent and prevalent. This means that although device design and development can confirm to regulatory requirements there are still wider social factors that get in the way. These include gaps in responsibility (people not being clear about who’s in charge of what), shared ownership of the design, competing objectives, isolated team members, power relationships and conflicts between requirements relating to safety and usability.
So why can’t we all just get along?
We found that although organisations work hard to overcome these challenges, in many cases, they were constrained in what they could do. Many of our interviewees felt that hands were tied due to inflexibilities in the overarching (European) regulatory frameworks. There is a question as to the extent to which safety regulations are providing for the design of easy to use devices, a point independently noted by a local design consultancy (“Is safety regulation stopping us from designing easy-to-use medical devices?“).
We concluded that there are ways of supplementing the “by the book” development (e.g. use of standards), using flexible, lightweight and versatile statements of intended user and usage (personas and scenarios*) which allow multiple professions to come together, share information and jointly reflecton the question “why are we building it like this?” The challenge for any technique that aims to share information regarding user and usage, is providing everything for everyone. We’ll be looking into this much more in the near future.
Chris Vincent, Yunqiu Li and Ann Blandford (2013) Integration of human factors and ergonomics during medical device design and development: It’s all about communication. Applied Ergonomics.
*There are lots of examples of personas and scenarios out there, you can see a demonstration relating to assisted living here:
http://www.dapforum.org/alipdemo/AlipWeb/Alip.htm (note that you may need to download MS Silverlight in order to view it)
We are working on our own, applicable to infusion pump design which are available on request (firstname.lastname@example.org)