Jan 12, 2021

Applying human factors engineering (HFE) best practices has enabled medical device manufacturers to delve into the realm of design thinking and provided users with products that are efficient and easy to use. The medical device industry is vast, and products can be intended for use by a variety of user groups (e.g., healthcare professionals, elderly patients, adolescents). As such, it is essential that regardless of the type of user, a medical device must be intuitive and user friendly, and any technical difficulties must be easy to diagnose and resolve. A vital step that?manufacturers can take when designing a product for a variety of users is to implement a simple but effective rule: Design with the end in mind.

In this case, “end” refers to the user, as ultimately the product must provide the user with a viable solution. This means that while it is beneficial to give thought to the cosmetic features and intricate details that make a product stand out, the design team and manufacturers must have the product vision and end user in mind.

A principle for “highly effective” medical device design

This idea of “beginning” with the end in mind is a notion taken from best-selling author Stephen Covey. In his self-help book, The 7 Habits of Highly Effective People, Covey states that if an individual begins a task with the desired destination in mind, then that individual has defined a clear direction that will lead them towards their goals. Applying this theory to medical device design, if a manufacturer envisions their desired end user using their product effectively and without difficulty, they will have defined a clear direction that will (hopefully) guide them towards creating a successful product that satisfies users’ needs.

Often, issues arise when manufacturers are not focused on the end user or assume they already know what their end users will need. An example of this can be seen in instances when manufacturers are focused on how to make their product stand out in comparison to competitor products. Designing with the competitor in mind, rather than the user, tends to result in usability issues. As another example, manufacturers that are under pressure to develop a product within a certain time frame might assume they already know their users and will not take the time to conduct research activities to discover their users’ true needs.

Designing with the end in mind means keeping one eye on the end goal (i.e., the main solution that the product is providing) while developing the product, so that the user can intuitively use the product to fulfill their needs. A common technique used within the HFE/user research world is to conduct a cognitive walkthrough to ensure the product is designed to accommodate the user. Such an activity will allow device manufacturers to pinpoint specific areas where the user might struggle to use the device.

Design to accommodate and empower your users

It is relatively easy to discern when a product has been designed with or without the end in mind. An example of this can be seen within a smartphone app that is associated with a medical device. Suppose a diabetes patient begins using an app that serves as an insulin dose calculator. The patient is tasked with entering information regarding daily consumption in order for the app to provide a recommended dose to inject. Before the patient can begin using the app, specific health-related background information is needed to ensure the recommended doses are valid and accurate. If data regarding the patients’ health is missing (e.g., user did not add BMI information) due to oversight, then the simple act of highlighting a specific button on the app that guides users to take action to complete the necessary step is quite effective. This feature is helpful because users are often tasked with completing a variety of steps whenever they are working with a medical device and/or app. This can provide an extensive mental burden on the user, especially if there is a looming medical diagnosis that also provides some level of stress and anxiety. When manufacturers inculcate features such as highlighting a button to remind patients to enter their data, the user might find the app intuitive and, as a result, feel comfortable using the app.

The addition of a smartphone app in conjunction with a medical device can empower patients by providing a feeling of control over their treatment and potentially decreasing the required frequency of in-office visits, all through their phone, a product that is already integrated into their daily lives. Additionally, if used appropriately, an app can help patients maintain an accurate history, which could result in receiving better care because their healthcare provider is more informed. The importance of designing these apps with the user population in mind can carry many benefits to the patient experience and should not be overlooked.

Whether it be the medical device, the instructions for use, or the smartphone app connected to the device, a manufacturer’s intended solution should aim to provide a user experience that is seamless and intuitive. This is beneficial for the end user as well as the manufacturer; by dedicating time and resources towards human factors studies and early user research at the beginning and throughout the product lifecycle, manufacturers can mitigate design issues that might arise down the line. Ultimately, although this idea initially stemmed from a self-help book, there are quite a few correlations between improving ourselves and improving product design to support end users. Ultimately, with a clear sense of direction and an understanding of “the why” behind any goal, we are one step closer to designing an effective solution.

Jay Ahuja is Human Factors Associate and Kimberly Nieves is Senior User Interface Designer at Emergo by UL's Human Factors Research & Design division.

Learn more about HFE and user-centered design for medical devices:

  • HFE user research?support?for medical devices, IVDs, and combination products
  • Medical device and product?evaluation
  • Whitepaper: Performing threshold analyses on user interfaces
  • Webinar: Human factors engineering for medical devices
  • Webinar: Safe in-person usability testing during COVID-19

Author

  • Jay Ahuja and Kimberly Nieves

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