Designing Devices to Be More Useful Than You Think

Sure, you can build what seems like a really high tech medical device, but is it going to be useful in an actual healthcare environment? And is the wireless functionality you've spent so much time integrating into that new device actually going to be useful?

With so many changes taking place in the healthcare industry, such answers are rapidly changing for Andy Schaudt, director of usability services for the National Center for Human Factors in Healthcare at the MedStar Institute for Innovation. Schaudt has significant experience in usability, safety, and human-factors engineering, having managed dozens of design projects across numerous industries such as healthcare, transportation, and aviation. (Schaudt will chair the usability conference track at MD&M West, in Anaheim, CA, February 10-12, 2015.)

MPMN recently had a chance to discuss the effects of the rise of mobile health, the transformation of the healthcare model, and much more. Here is how Schaudt answered our questions:

MPMN: How has mobility become important in the healthcare environment, and what are the major challenges around it?

Schaudt: The rise in consumer demand for mobile applications is leading patients to ask for things like remote access to healthcare providers and wellness apps.

The tough thing is that a lot of care is still being done within hospitals and facilities that have environments that weren't necessarily built with a true wireless and mobile environment in mind. Hospitals don't always have the infrastructure to be able to support a lot of mobility and wireless technology.

There are a lot of Web-based apps being developed that sometimes won't work in hospital environments because the lack of WiFi availability and poor cell phone signals. In addition, you can't necessarily think that your device's Bluetooth connectivity will work in a healthcare environment because there could be a lot of other wireless signals that could cause interference.

Interoperability is an important consideration. If you are replacing something with a wireless and more mobile option, it could be potentially unsafe if you attempt to implement technologies into environments not built to accommodate them.

MPMN: The whole mobile trend is leading to an increased use of batteries in medical devices. What should device developers keep in mind there?

Schaudt: The use of batteries and charging can change the workflow for healthcare professionals. Although it might be helpful to have your medical device be wireless, its battery can run out and then you are adding a task to the provider's workflow. I have observed clinicians grab a medical device and use it to take care of a patient and the device battery dies and they can't find another one. For example, a nurse or technician is making a round to take vitals and is using a portable wireless device to enter in those results, which connects directly to the electronic health record (EHR). During their round, the battery dies and they have to revert to some other method such as finding a workstation on wheels, or writing results down on paper and taking it back to a computer station to manually enter it into the EHR. The poor reliability of this device has resulted in an increase of time-on-task, and the increased chance for an error.

Another thing that can happen is the batteries get old and won't hold a charge well. These issues can actually increase the potential for risk rather than make things more efficient.

Some medical device companies are not just trying to develop a product to sell; they are developing a product and supplying a service to help hospitals maintain the devices. It is important to think about the device's maintenance and the reliability early in the product design cycle. Healthcare systems, although they are starting to incorporate and procure more of these mobile technologies, don't necessarily have the ability to quickly beef up their wireless infrastructure or their maintenance crew. It is important to think about whether you should add a support service early in the design of your business model.

The key point is to think about all of the users of the device when designing a mobile medical device. This includes those who maintain it, upgrade it, use it, charge it, and maintain the wireless infrastructure supporting it. You could be designing for a team of people, not just a single user.
 

MPMN: Can you give me an example of the workflow considerations that are relevant here?

Schaudt: Let's take the example from earlier. The nurse is using a mobile device to record vitals during some basic rounds in the ICU. Any one of numerous issues may arise, such as the battery dies, or the device can't connect to the wireless. Is it the nurse's responsibility to go find a workstation on wheels? Or should he/she be in charge of keeping the devices charged? Maybe. But that adds another task to their already busy day. Maybe the biomedical engineering team for the hospital should be responsible for charging those, in which case, what is their workflow like? Do they have people staffed there at night? If not, that means the your device should probably maintain a charge for 12 to 16 hours at least.

The bottom line is that you should think not just about the user who is using it to provide care but also the people who work to make it reliable. 
 

MPMN: What should medical device developers know about recent changes in the healthcare care model and how should that affect their design process?

Schaudt: There is this slow shift away from a hospital-centric model to more of a distributed-care model. There are a lot more ambulatory facilities and home care initiatives being introduced.

From a usability and human factors standpoint, it may be important to start thinking of your devices being used outside of their original intended environment. There are more office buildings being reformatted to be an ambulatory care facilities. A lot of times, equipment that is made for the hospital is being used in the home instead.

That is an important thing to think about when you are designing your system: it may be used for 5 to 20 years. But what is healthcare going to be like 5 to 20 years from now? There is a really good chance it is going to be much more distributed. So when you design these systems, think about the fact that they are going to be used for a very long time and try to design the system so they are as easy to use as possible. It may be the case that patients end up using the device themselves rather than healthcare professionals. This design should be minimalistic and intuitive. It should not have a barrage of features. If there is a chance that the device could end up in a home care setting, think about all of the new challenges that you could run into. Who knows, your medical device or its cord might get chewed up by a dog.

MPMN: You mentioned earlier the importance of avoiding adding extraneous features to medical devices. What else can you say about that?

Schaudt: When a medical device company creates a device, they often have their marketing team and customer service team keeping track of issues and requests for new features. What often happens is you have a lot of features or requests for customization added as you go along. What happens is these devices tend to get more complex over time. But when you do that and you have features that aren't commonly used, it can actually be an issue and increase the likelihood of a use error.

I would say it is important to design for the end user and not based on the feedback alone you are getting from your own internal marketing and customer service teams. The information can still be useful, but I highly recommend you think it through thoroughly from the end user perspective.

Another thing to think about, your customers aren't always the end user. And a lot of times, the end users say what they think they want but that might not necessarily be what they need with regards to safety.

You may have to spend some money to do human factors and usability tests and design processes, but when you avoid major errors and recalls and problems with the interface by focusing on the end user and thinking about those sorts of things, it is going to be much more valuable, and cost effective, in the end.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.