How AstraZeneca’s Lead Human Factors Engineer is Improving Drug Device User Experience by Integrating Patient Input

Tell us about the work you lead at AstraZeneca.

I work on the development of inhalation devices for patients, mostly with COPD and asthma. There are a couple of different kinds of inhalers we are working on. My main focus is on a new inhaler device to be used as a platform for combination products down the line. We are doing research to understand what patients need and want from this inhaler, how we can make sure their dose is delivered, how we can make it safe and convenient for daily use. If patients don’t take their medication continuously, they won’t get the benefit so developing a newer platform that is convenient to use is paramount.

I also have some lifecycle management work with other inhalers around making improvements and rewriting the way patients use our devices. If they enjoy using these devices and learn while they are using them in a way that makes them want to continue, they will receive the therapeutic benefit. 

How has your experience as a device-using patient influenced your approach to patient-centric design? 

Patient-centered drug delivery is vital. No matter how wonderful the product is, if people don’t use it because it’s annoying or difficult to use, it isn’t wonderful. My interest in this started when I was really young and was diagnosed with diabetes. I had to wear a lot of devices and they were so frustrating to me. There were alarms that would go off that I couldn’t silence, regardless of whether I needed them or not. This meant that when I was on stage playing my violin, I would opt to turn my device off and leave it backstage rather than have it on me, because I didn’t want it to go off while I was performing. This obviously wasn’t the intent for how these devices should be used when they were designed.

Sometimes when devices are under development, they are designed not only for the engineers but also for the regulatory bodies, which makes sense. But there can be unintended consequences for patients. One of the things I try to always keep in mind is the way patients are using the product and what kinds of things annoy patients and how we can eliminate those annoyances.

How can companies better improve user experience from the beginning of product development?

The more you can do early the better. The longer you wait, the more resource intensive, expensive and time consuming it becomes and then even seemingly simple changes become more cumbersome. There is already a lot of work done to make sure that you are compliant with regulatory requirements, including precautions that might not be necessary. If you can include engineers developing the device with the clinical team developing the therapeutic side you can probably better develop a combination product that satisfies regulatory requirements while maximizing drug benefit. If you can include patients on that committee as well, you can integrate their needs into the development too. Currently, there isn’t a lot of cross-functional communication and alignment so there is a lot of unnecessary effort. 

Also, different countries have different requirements. It can be difficult to develop the best device and the best labeling and instruction for use. To satisfy all of these different requirements the instruction documents grow more and more to the point where it is hard for patients to find relevant information. It would be great to see nations worldwide work together to make things more efficient just as it would be great to see more patients and developers working together to have beneficial open conversations.

"Patient-centered drug delivery is vital. No matter how wonderful the product is, if people don’t use it because it’s annoying or difficult to use, it isn’t wonderful."

Do you have examples where patient input changed the direction of device design?

In the diabetes space in particular, there is patient-led development, like open source artificial pancreases and automated insulin delivery devices. I’ve been part of that completely patient driven group, where it is patient input, patient needs, device needs, etc. 

At AstraZeneca, we’re working on something with drug and a device and some of the feedback we’ve gotten was about it being difficult to travel with. We’re advocating for ways to make it easier to keep the medication together in a smaller package while maintaining the safety and storage parameters. We get a lot of feedback from patients of all ages and use that feedback to develop further. 

Do factors like patient age impact the design you pursue?

Definitely. For example, young children might be used to using an inhaler with a spacer. These past experiences can impact the way they want to use the inhaler we’re developing. Maybe you’re used to pushing a button and breathing in through a spacer or maybe you’re used to a breath-activated inhaler. These are completely different devices and are used differently. 

We have also spoken with caregivers of people with memory issues who basically need to reteach their loved one how to use the inhaler day after day. The workflow can also be different if someone lives in a facility or at home. You need to develop the workflow for all of these different instances.

"The more you can do early the better. The longer you wait, the more resource intensive, expensive and time consuming it becomes and then even seemingly simple changes become more cumbersome."

How do you bring your experience as a patient to the development of devices?

Even when I was working on diabetes devices, with friends in the space on both the patient and development sides, I would still be surprised by something someone would say in a usability study. You need to remember that even when you’re developing for people with similar diagnoses as you, they aren’t you and they will have different wants and needs. Sometimes what people bring up triggers something within me and I can validate their needs and that hopefully leads to better ideas, insights and innovations. 

What role do you see digital health playing in improving patient experience?

As a human who has had many diabetes devices, I’ve had devices that connected to specific transmitters and receivers and others that connected to my phone. A lot of people in industry assume that connecting to a phone is automatically good but everybody is going to have a different viewpoint. I remember being in school and being yelled at by teachers when my pump would beep. If my pump was connected to my phone, then I might be seen as rude when I pull out my phone in the middle of a conversation to check my continuous glucose monitor or give myself insulin. 

This was a big problem when I was taking the GREs because you weren’t allowed to bring phones into the test but my continuous glucose monitor and artificial pancreas were connected to my phone. 

"Even when I was working on diabetes devices, with friends in the space on both the patient and development sides, I would still be surprised by something someone would say in a usability study."

Anything else?

Patients are absolutely central to device development. We get bogged down in a lot of other stuff. I have spent a lot of time working in public health and so I am a patient resource but so are the many patients like me who don’t work in the pharmaceutical industry. They can bring experiences and ideas that should not be discounted. By having formal and informal conversations with patients and allowing them to interact with devices earlier in development you can really change the route of development for the better. Don’t discount patient voices.

I also think a big effort in sustainability needs to come from regulatory bodies. Patient usability and sustainability are not necessarily correlated and I think guidance from regulatory bodies on prioritizing both will go a long way.

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