User research is gaining recognition across the medical device industry as an integral and investment-worthy element of the product development cycle. Companies typically view it as a tool to aid in designing medical devices. However, if this is the only way you are leveraging user research, you could be missing out on opportunities for holistic design thinking that will strengthen your resulting product.

In the world of drug delivery, user research conducted early in the development of a combination product can inform formulation efforts. When the formulation team needs to decide between two possible pathways or they have an opportunity to change certain aspects of the formulation, how do they know the best way to proceed? Understanding the end users’ needs can help the team prioritize or adjust when it is still possible.

In the past we have conducted early contextual research with patients whose medical condition results in moderate to severe hand impairment. For these end users, even a slightly viscous drug would require too much force for them to self-inject through a traditional syringe needle. When user research surfaces these challenges early in development, the product team can determine how they might influence critical properties to reduce the formulation viscosity appropriately.

Conversely, if a slighter higher-than-normal viscosity is not as much a concern for the specific patient set, or if an acceptable device-based solution to the challenge is readily available, the formulation team can expend less time and effort reducing viscosity and focus attention elsewhere.

Early contextual user research also informs packaging, labeling and instructions for use. For example, we have conducted contextual research to understand how patients store and administer oral medications such as pills, capsules, and tablets at home.

In one study, the product being developed was a moisture-sensitive capsule. Proper storage required the capsule to remain in the original container with desiccant until its ingestion and user research revealed that many patients use weekly pill organization systems to sort their pills by day of the week and time of day.

These systems helped to remind them when to take their pills and also served as a confirmation that they did, making the sorter a vitally important element of their medication administration. To encourage proper use through the packaging design and intuitive labeling, we maintained that familiar workflow by integrating dosing instructions into the packaging and making the design resemble the “pill counter” mental model. We also used words and images that best conveyed crucial instructions such as “do not remove” or “do not get wet” to these patients.

As these examples demonstrate, planning and conducting contextual user research is a valuable and significant investment that should not be limited to informing only device design. The earlier and more holistically user research is incorporated into your design thinking, the greater the potential for return on your investment and increased chances for product success.