Improving Collaboration & Balance Between Human Factors Engineering & User Experience Design in Medical Devices

The tension between safety considerations and user experience design (UXD) in the medical device industry reflects broader regulatory and market pressures. When designing and developing medical devices, companies are often under intense pressure to bring their products to market as quickly as possible. The pressure to meet time-to-market deadlines often results in prioritizing features and aspects of the device that ensure compliance with regulatory approval requirements. Balancing a focus on safety with designing for usability and user satisfaction is possible with an integrated approach that starts with early user research.

The U.S. FDA has stringent requirements for medical devices to ensure they do not pose undue risk to patients. These requirements often emphasize safety and effectiveness, leaving less room for considerations of user experience beyond these parameters. Since regulatory approvals are mandatory for market entry, and they predominantly focus on safety, there is an inherent push to prioritize safety over other aspects like usability or user satisfaction. While regulatory approvals are essential for market entry and to prioritize safety, it's crucial to recognize that ensuring user satisfaction and usability are equally vital components in the design and development of medical devices.  

Related:Supporting Design of Patient-Centric Devices

Safety and error mitigation are paramount because the consequences of failure in a medical context can be severe, including harm to patients. However, this focus can sometimes result in products that are safe but difficult or unpleasant to use. Such issues can lead to user errors, non-compliance with treatment regimens, or even reluctance to use the device, ultimately impacting patient outcomes.

The challenge lies in finding a balance between safety and user experience. Innovators in the medical device field are increasingly recognizing the value of integrating user-centered design principles early in the development process. This involves engaging with end-users—healthcare professionals and patients—to understand their needs, preferences, and the contexts in which devices will be used. By neglecting doing so, the responsibility falls on the product development team to devise products predicated on stakeholders' subjective conjectures instead of utilizing insights derived from empirical evidence regarding human behavior and requirements.

Differences Between HFE and UXD 

UXD and human factors engineering (HFE) both play critical roles in the design and development of medical devices, aiming to optimize the experiences of patients and healthcare professionals. While these disciplines share the common goal of improving user interaction with products and systems, they are underpinned by distinct principles and approaches. Understanding the differences between UXD and HFE is key to appreciating how they contribute to medical device development.

Related:FDA Finalizes Human Factors Guidance in Combination Medical Devices

HFE focuses on understanding human behaviors, abilities, and limitations and applying this knowledge to the design and engineering of systems, products, and environments to ensure they are safe, effective, and user-friendly. In the context of medical devices, HFE emphasizes minimizing the risk of error, enhancing performance of user tasks, and improving safety through ergonomic design and user-friendly interfaces. HFE is deeply rooted in research methodologies that assess and mitigate risks associated with the use of devices, including task analysis, contextual inquiry, formative evaluations, and summative validations.

UXD, on the other hand, encompasses a broader scope that focuses on all aspects of the user's interaction with the device, aiming to create products that are not only functional and usable but also delightful to use. UXD encompasses the emotional, psychological, and aesthetic aspects of user interactions. Its goal is to create a seamless, intuitive, and engaging experience for users. It integrates a deep understanding of users’ needs, values, abilities, and limitations throughout the design process to tailor products that meet or exceed user expectations.

While HFE is primarily concerned with the safety, effectiveness, and usability of medical devices from an ergonomic and cognitive perspective, UXD takes a more holistic approach. UXD includes the HFE considerations and extends to the emotional and aesthetic experience of the user. HFE can be seen as a subset of UXD, or as complementary disciplines that, when combined, contribute to the comprehensive design and engineering of user-centered medical devices.

In practice, the integration of HFE and UXD in medical device development ensures that products are not only safe and functional but also resonate with users on a deeper level, fostering acceptance, satisfaction, and long-term adherence to treatment. Successful medical device design requires a balanced approach that considers both the rigorous safety and usability standards of HFE and the broader experiential goals of UXD. 

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Collaborating in Early Stages of Product Development 

The early stages of collaboration between HFE and UXD in medical device development are crucial for setting the foundation of a product that is safe, effective, and provides a satisfying user experience. Engaging both disciplines from the outset helps ensure that user needs, behaviors, and limitations are central to the design process, facilitating the development of medical devices that are both user-friendly and compliant with regulatory requirements.

Conducting comprehensive early user research is one of the first steps where HFE and UXD collaborate. This involves qualitative methods such as interviews, observations, and contextual inquiries with potential users, including patients, healthcare providers, and other stakeholders. The goal is to gather insights into their experiences, needs, preferences, cognitive and emotional capabilities, and limitations as well as the contexts in which the device will be used. This research is vital to define the user requirements that will drive the design process.

Contextual inquiry (CI) is a valuable research method that greatly enriches the development team's understanding of user workflows and challenges. It reveals users' explicit and implicit needs by seeing how they interact with devices or systems in real-life contexts. The rich, qualitative data gathered through CI supports evidence-based decision-making throughout the design process. It helps inform design decisions and prioritize features and functions that are most valuable to users, supports regulatory submissions, and guides future iterations of the product to ensure that the final product is both useful and used. Understanding the context of use is also critical for meeting regulatory requirements. Insights from contextual inquiry can support compliance efforts by providing documented evidence of user-centered design practices.

The Role of Design Engineers

Having design engineers present during the CI studies allows them to gain firsthand insight into how users interact with existing systems or prototypes. This direct exposure can spark creative solutions and foster a deeper empathy for the user's experience. Being done early in the design process, design engineers can identify use-related risks and design features to mitigate risks, ultimately enhancing the safety and usability of the device.

HFE professionals document the product’s design criteria, considering aspects such as the intended use environment (e.g., hospital, home), user demographics (e.g., age, physical abilities), and specific user needs. This documentation helps in determining the initial design considerations, such as the device's form factor, its information architecture, and the interaction paradigms it should support. 

Integrating CI from the start of the design journey offers numerous advantages:

Skipping these useful HFE methods in the early stages of medical device development can lead to significant challenges down the line, particularly necessitating more substantial changes to the design later in the process. Discovering that a design does not adequately meet user needs or fit within their work practices at a later stage in the development process often requires going back to the drawing board. Significant design revisions are not only costly but also time-consuming, potentially delaying the product's time to market. In the medical device industry, demonstrating that a product meets the needs of its users and is safe and effective for its intended use is critical for regulatory approval. When significant usability or safety issues are found late in the process, it can complicate regulatory submissions and lead to additional rounds of testing and documentation.

UXD/HFE Collaboration Throughout Product Development 

To further collaboration between UXD and HFE professionals, formative evaluations are pivotal in gathering and integrating user feedback to refine and enhance product design and engineering. 

UXD and HFE professionals conduct formative evaluations where they can observe users interacting with prototypes or early-stage products, noting any usability issues, challenges in navigation, and areas that may cause confusion or errors. Insights from user feedback are used for rapid, iterative design changes. The iterative nature of formative studies allows for ongoing refinements, with each round of feedback leading to improved designs. UXD and HFE experts analyze the qualitative and quantitative data together, synthesizing information to create a holistic understanding of the user experience. The collaboration ensures that findings are translated into actionable design and engineering improvements. This iterative approach to design also meets the expectations of regulators by showing HFE has been implemented in an iterative manner optimize the design for safety and effectiveness.

Conclusion

The close collaboration between UXD and HFE professionals is key to the successful design and development of medical devices.  

By integrating user-centered design principles early in the development process and conducting comprehensive early user research, companies can ensure that their products not only comply with rigorous regulatory standards but also meet the complex and diverse needs of users. This collaborative approach not only improves healthcare delivery and patient care but also fosters acceptance, satisfaction, and long-term adherence to treatment. Ultimately, successful medical device design and engineering requires a balanced approach that considers both the rigorous safety and usability standards of HFE and the broader experiential goals of UXD. Through ongoing collaboration and iterative design processes, UXD and HFE experts can create medical devices that not only meet regulatory requirements but also exceed customer expectations, enhancing both the user experience and patient outcomes.