What is design’s role in the future of healthcare?

With all of the discussion about how to fix health care and who’s going to pay for it, it really made me think about another issue that rarely gets mentioned: accidental deaths and accidents that can be traced back to medical devices.

Back in 1999 IOM (Institute of Medicine) report stated that there were from 44,000 to 98,000 deaths each year from medical accidents. I can accept dying and death as part of life, but I can’t imagine how angry I would be if a friend or family member’s death was because of a mistake or accident that someone made.

As a result of this awareness of accidental deaths, a lot of efforts were and continue to be put in place to reduce this number. From “sign in” and “time out” procedures to training and automation of tasks, the medical industry expectedly wants to reduce accidents from happening. Many of these efforts are associated with human error, but human error is a result of a poor interaction with a device, system, or process. Human actions do not happen in a vacuum. Even incorrect choices and decisions that happen internally are impacted by the mental load and other cognitive factors that the operator finds themselves in. This is not to say that human behavior can’t be improved through training and skill improvement, but blaming the human is too easy and lets the device, environment, and process designers off the hook. Better designed products take into account the human fallibility and provide safeties and other limits to help reduce errors or their impact. To do this, you must understand humans and their environment in ways much deeper than their needs and ways they currently work.

According to an FDA spokesperson at the AAMI conference in DC in June (2005), “more than one third of medical device incident reports involve use error, and more than one half of the recalls due to design problems can be traced to the design of the user interface.” What’s happening here?! User interaction, information architecture, and interface design are relatively mature disciplines with established processes for design and evaluation. Why are MORE THAN one half of the recalls due to problems related to an effort that people consider to be well founded and with specific processes that if followed should result in interfaces that are not a problem?

It has been five years since that data was collected, and while I don’t have the new exact number, I know that there have been great strides in design to be more user friendly and to help mitigate risk. But the underlying problem is that most designers do not respect the level of complexity associated with designing a medical device whether the physical or interface parts. Not to put all the blame on the designer because many times they are just given the functional/feature requirements and asked to develop the interface or physical actuations. Many times the requirements and input that comes to the design team are from ‘voice of the customer’ needs provided by a sales team. The user testing that happens is not remotely close to what the actual use environment will be.

Designers, researchers and OEMs need to be much more rigorous in their research and design efforts. If the devices can be made easier to use, our industry can play a huge role in the healthcare industry by helping clinicians reduce the amount of fatal incidents (they are human after all).