User-Centered Research Methods For Medical Device Design

Aishwarya Suresh is a UX Design Manager at Medtronic, specializing in the design of medical devices.

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the application of usability engineering to medical devices, along with the FDA’s guidance on human factors and usability engineering, outlines essential frameworks for achieving these goals.

However, the responsibility for selecting and applying appropriate research methods to assess the device’s usability and overall user experience ultimately rests with the design and research team. Here are some considerations for selecting the research methodology.

Phase Of The Project

Starting research early offers significant benefits when designing the right product. Contextual inquiries are particularly valuable during this phase, as they allow designers and researchers to immerse themselves in the users’ environment. The goal at this stage is not to assess the usability of a product but to generate insights, identify pain points and uncover opportunity spaces.

This deep understanding of users’ constraints and environments is crucial, especially when designing complex medical devices like large, immovable machines such as MRI or CT scanners. By gathering this knowledge early, designers can carry it with them as they begin translating ideas into design concepts. Even if the product only has a few touchpoints during the research, understanding the tasks that healthcare professionals perform outside of the medical device being studied can significantly broaden the design perspective.

In the later stages of a project, during the development phase, testing the usability of the medical device becomes crucial to ensure that the product is designed effectively, allowing users to complete typical tasks successfully.

In the medical device industry, these usability studies are known as formative evaluations. It often utilizes task analysis methodology, where participants are observed in a simulated environment and are asked to perform tasks that are representative of those commonly carried out with the medical product.

Level Of Complexity

Medical devices are often inherently complex, largely due to the expertise required by their users. While users are typically highly skilled professionals with a deep understanding of the medical field, they may not always be technologically adept. In contrast, designers possess a strong grasp of the technology involved but may lack the specialized medical knowledge necessary for creating effective products.

This highlights the importance of designers and researchers gaining a solid understanding of the medical domain before embarking on the design of a medical device. One effective strategy is to begin by documenting the user journey and the protocols users follow when interacting with the device. Protocols are standard across many medical devices, breaking down tasks into manageable components.

By understanding the rationale behind each step and its medical significance, designers can build the foundational knowledge needed for effective design. This process then informs the creation of tasks for formative evaluation, where task analysis can be used to assess and refine the device’s usability.

Simulating Real-World Scenarios

Simulating real-world scenarios is one of the most challenging yet essential aspects of testing a medical device in development. While it may not be easy, it’s crucial to replicate the real-world environment as closely as possible, with lab simulations providing an effective starting point. This approach helps set the user in the right mindset when performing tasks on the device.

However, such simulations often fall short due to several factors like extended usage or variations in the time of day that can influence the user experience. To capture these nuances, methods like diary studies can be incredibly useful.

In this approach, users are given a prototype and asked to use it as though it were the final product. Over a set period, they document their experiences, both positive and negative, which are then reviewed with the researcher in follow-up sessions. This process provides valuable insights into how the device performs over time and in varying conditions, ultimately guiding improvements for real-world usability.

Defining Goals

While these are key considerations when selecting the appropriate techniques for UX research and usability studies, it’s essential to first define the goal of each study. Clearly understanding the objective naturally guides the selection of the most suitable techniques to achieve it. These flexible methods can be adjusted as needed to better align with the study’s evolving requirements. Additionally, it’s crucial to ensure that the study design is unbiased and that it frames the right questions to gather meaningful insights.

Designing effective and safe medical devices requires a deep understanding of both the technological and medical domains. User-centered methods, such as contextual inquiries, task analysis and real-world simulations, are essential for ensuring usability and addressing the unique challenges these devices present.

By selecting the appropriate techniques based on the phase of the project, the complexity of the device and the goals of the study, designers and researchers can create products that meet the needs of healthcare professionals and improve patient outcomes. Ultimately, continuous collaboration and flexibility in the research process will ensure that medical devices are not only functional but also user-friendly in real-world settings.

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