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Battelle Medical Devices Updates

Battelle Medical Devices Updates

Industry Insights
researcher tests a medical device's usability

To Raise Adherence Rates, Put User Needs First

By Debbie McConnell

What’s the secret to improving patient adherence rates? It starts with giving them something they need. Medical device design that ties patient needs to the actions we want them to perform can significantly improve adherence, acceptance, and satisfaction.    
 
Consider the airplane lavatory door. Airlines have a behavior that they want to encourage: they want users to lock the door behind them when using the lavatory. Users have a need: they want to be able to see what they are doing. The simple, elegant solution is to tie the need (light) with the desired behavior (locking the door). The light comes on only when the door is locked. The same approach can be used to improve patient adherence regarding medical devices. 

Aligning The Needs Of Manufacturers, Providers and Patients 

When I ask my medical device manufacturing clients how they would like to measure success after their new product is commercially released, the answer is always twofold. One answer is related to dollars: increased sales and market share, reduced manufacturing costs, etc. The second answer involves the benefits the medical device could bring to the intended patient population, such as better management of symptoms, increased independence, or prolonged life. Often, the patient must follow specific instructions or make lifestyle adjustments to achieve these outcomes, making patient adherence crucial.

The good news is that both manufacturer and patient needs often can be met at the same time using principles of human-centric design (HCD). A device that better meets the needs of its intended user population will result in better patient adherence and satisfaction, ultimately leading to better health outcomes and increased product adoption. 

A great example of this can be seen in the world of insulin pumps. Insulin is a vital need for individuals with type I diabetes, so you wouldn’t expect there to be many adherence problems with wearable insulin pumps. However, many people living with diabetes struggle when it comes to using their pumps as intended. For example, pumps with tubing can be awkward and unsightly, must be removed for activities such as bathing, and can make it difficult for patients to wear certain clothing styles without embarrassment. Patients may therefore remove their pumps more than they should to avoid tubes that get in the way of activities, prompt unwelcome questions or simply make them feel uncomfortable with their bodies. 

Insulet solved this problem with OmniPod, the first untethered insulin delivery device approved for sale in the U.S. by the FDA. OmniPod is small, waterproof and completely tubeless, so it can be discretely affixed to the body where it will not show and can be left in place through all normal daily activities. Reimagining the insulin pump has resulted in better adherence from type I diabetes patients. It has also been great for Insulet’s bottom line: since launching the OmniPod System in 2005, sales have grown to more than $320 million for 2015, with strong double-digit growth. 

Understanding User Needs

How do you know what users need? It starts with something most of us already do: spend time observing and talking with patients. Box CEO Aaron Levie has said, “You’ll learn more in a day talking to customers than a week of brainstorming, a month of watching competitors or a year of market research.” While this applies to all types of products, from software to sporting goods, nowhere is it truer than in the medical device market. 

To get the most value out of user observations, usability researchers use a process called contextual inquiry. Contextual inquiry is a semi-structured interview method, generally conducted in the environment where the user will interact with the device, such as the home or clinic. The goal is to obtain information about how the device is used within the context of use. Users first are asked a set of standard questions, and then observed and questioned while they work in their own environments.

Compared to survey methods, contextual inquiry can give researchers a much more nuanced and accurate understanding of user needs, wants and challenges. Users are not always able to articulate their needs when asked survey questions; they may not remember things accurately when they are not actually interacting with the device, or they may neglect to mention an issue because they don’t see its importance for device development. Answers to surveys also depend on highly subjective interpretation of the questions, making it difficult to generalize results from large data sets.  

Contextual inquiry gives researchers the opportunity to listen to what users say as well as observe what they actually do while using the device, uncovering insights that users themselves may be unaware of. While observing patients and healthcare providers in their own environments, we can uncover the gaps between what they have and what they need. We notice times when they are accommodating for the lack of a better solution: sticky notes, crib sheets, two-person tasks that could be one-person tasks, etc. We also notice when it’s just too hard for them to comply with required behaviors. In a healthcare setting, these instances may result in missing data in a patient chart or delays in non-critical patient care. At home, patients may make mistakes when taking medication, neglect to note events of interest requested by their doctor, or simply fall away from a beneficial practice that just feels too hard.

After observing, researchers can take the data from time in the field and distill it into unmet needs that were expressed in the language of the patients and healthcare providers. This information then is used to find design solutions that address these unmet needs and make it easier for users to adhere to the device’s intended use.  

Design With The End In Mind 

The second habit in Stephen Covey’s 7 Habits of Highly Effective People is “Begin with the End in Mind.” This is also a foundational principle of the six sigma lean practices, and excellent advice for medical device manufacturers. 

We start with a goal: what is it that we want the patient or healthcare provider to do? For example, we may need them to input required data into an app or device, take a blood sugars reading before injecting medication, or keep a nebulizer in place long enough to get the entire dose of their medication. Then we ask the question: what is it that the user wants or needs from this experience? We use both inputs to drive concept design. The outcome is a product that ensures that the medical device manufacturer will achieve its success measures by providing patients and healthcare providers with a product that they will use as intended, because it meets their needs.
 
For example, many people with life-threatening allergic reactions fail to carry potentially life-saving epinephrine autoinjectors with them at all times because the devices are bulky and inconvenient to carry. Sanofi developed a smaller, more portable injector: the Auvi-Q, about the size and shape of a smartphone, and easily pocketable. Auvi-Q also is equipped with sound recording to provide voice instruction, so “good Samaritans” with no training can operate the device on behalf of an incapacitated person.*  

Finding design solutions that meet manufacturer needs for increased adherence, as well as user needs and desires, requires a human-centric approach to device design and development. HCD keeps the needs and preferences of the user at the center throughout the process, starting with early concepting, in order to increase users’ ability, desire and willingness to use the product as intended. This adherence is key to realizing the potential benefits of the product as well as ensuring its safe use.

Small adjustments to product design can have a big impact on final adherence and product adoption rates. For example, a pharmaceutical company wished to improve the adherence rate for a medication that required behavioral changes on the part of the patient. Specifically, patients needed to wait a period of time after taking the medication before eating, and were asked to consume a large amount of water during this period. Contextual research provided information about how patients live their lives and currently take medication. Those findings helped to inform the product’s packaging design and aided in the creation of clear, concise instructions for use that resulted in a 92% success rate. 

In my experience, integrating user needs from the very beginning can significantly improve the chances that the final product will gain user acceptance and promote user adherence. It also reduces the chances that safety and usability concerns will be uncovered late in the design process when they are costly to correct. 

When medical device design really works, the result is a product that fully meets the needs of users while helping device manufacturers meet their financial goals. It’s the perfect example of “doing well by doing good.” By finding product design solutions that increase user adherence and satisfaction, manufacturers can improve both patient outcomes and the bottom line. 


*The Auvi-Q has been recalled due to possible issues with dosing accuracy. However, there is no evidence that this issue is related to the user interface design. 

About the Author
Debbie McConnell has 25 years of experience working with product development teams in private industry, public service, and government agencies, specializing in human factors. As a Human Factors Lead at Battelle, she has hands-on experience across all phases of the project development lifecycle, including user research-based design inputs, use error analysis, prototyping, usability testing, summative validation studies, regulator body submissions and product launch support.