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Applying Human Factors and Usability Engineering to Medical Device
Applying Human Factors and Usability Engineering to Medical Device Development
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Tips for applying Human Factors and Usability Engineering to Software as a Medical Device (SaMD)

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Jan 11, 2024

12 min read

samd series | author

Weronika Michaluk

Digital Health Principal
SaMD Lead at HTD Health

When we talk about applying human factors and usability engineering to medical devices, we mean designing these devices with the user in mind and making medical devices not only useful but also easy and safe to use.

This approach helps to make sure that medical devices meet the needs of the people who use them, like doctors, nurses, and patients. It’s all about making devices that are straightforward, easy to handle, and less likely to cause errors.

In this process, we also focus on following the FDA’s guidelines for medical device usability. This means we pay close attention to the FDA’s advice on how to make medical devices user-friendly. This includes testing how real people use these devices in real situations. It’s important because it helps us to understand and fix any issues with how the device is used. Overall, applying human factors and usability engineering to medical devices makes them safer, more effective, and easier for everyone to use.

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Beginning of human factors

The human factors and usability engineering as applied to medical devices today have their roots in the fields of psychology, engineering, and physiology, gaining prominence during World War II. This era highlighted how poor design could lead to human errors in operating complex machinery, like aircraft. By following human factors principles, such as redesigning airplane cockpits, pilot errors were significantly reduced.

As the field expanded beyond military and aviation contexts, it began to incorporate insights from psychology, sociology, engineering, design, and computer science. This multidisciplinary approach focuses on tailoring systems to match human physical and cognitive abilities, aiming to make them safer, more efficient, and user-friendly.

In the healthcare sector, the importance of human factors and usability engineering in medical devices and Software as a Medical Device became evident after studies showed that many medical errors stemmed from flawed system design rather than individual mistakes. By applying human factors and usability engineering to medical devices, designers can create products that inherently reduce the risk of errors, safeguarding patient health. This approach is essential in any system where human interaction with machines or software is involved, with the ultimate goal of enhancing functionality by aligning with human capabilities and limitations.

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Understanding human factors and usability engineering

Human factors and usability engineering are key in designing medical software, focusing on enhancing user interaction, minimizing errors, and improving the overall user experience. This approach is essential in applying human factors and usability engineering to medical devices, ensuring they not only function well but also align with user needs.

This field brings together diverse expertise, essential for applying human factors and usability engineering to medical devices. Software developers, psychologists, ergonomists, cognitive scientists, and engineers collaborate to ensure all aspects of human interaction with medical device software are considered. Their combined efforts lead to intuitive, user-friendly interfaces, informed by FDA usability guidance, and aligned with human factors medical device standards.

A primary objective is to obtain intuitiveness in software design, making user interactions as seamless and error-free as possible. This involves understanding user thinking patterns, expectations, and interactions with the software. For example, in a healthcare setting, inputting patient information should be quick and error-proof, possibly incorporating features like autocomplete or easy navigation, adhering to FDA medical device usability guidance.

Another example, is in a medication management app for patients with tremors, selecting medication dosages should be straightforward and error-resistant. The app could use sliders with large grab handles and extended touch targets, making adjustments easier and reducing the risk of selecting the wrong dosage, in line with FDA usability guidance for medical devices.

In a telemedicine app designed for patients with tremors, initiating a video call with a healthcare provider should be a simple, stress-free process. The app might include a ‘one-touch connect’ feature with a sizable, stable button, minimizing the physical effort and precision needed to make a call, adhering to the principles of usability engineering for medical devices.

In medical contexts, where mistakes can have severe consequences, reducing human error is paramount. This involves designing software with built-in safeguards, such as double-checks for critical tasks like medication prescribing and creating clear, straightforward interfaces to prevent cognitive overload. These measures are crucial in medical device usability testing and align with the principles of human factors testing.

Beyond functionality, the user experience (UX) is a vital aspect of usability engineering in medical devices. UX focuses on the ease and satisfaction of using the software, influencing how healthcare professionals interact. A positive UX can lead to more effective use of the software, ultimately enhancing patient care. In the next paragraph, we will talk more about the importance of applying human factors and usability engineering.

The importance of human factors and usability engineering in medical device software development

Understanding human factors and usability engineering and applying them to medical devices is crucial in the field of medical software development. This approach, guided by FDA usability guidance, plays a pivotal role in shaping the outcomes of medical device software, impacting everything from patient safety to financial performance. Here we explore the key benefits of using human factors and usability engineering in Software as Medical Device.

Enhancing patient safety

The application of human factors and usability engineering to medical devices, particularly in Software as a Medical Device (SaMD), enhances patient safety. This process involves designing and developing medical software with a thorough understanding of the end-users’ needs, capabilities, and limitations. By focusing on human factors, such as cognitive abilities and physical limitations, and by designing intuitive interfaces and workflows, SaMD becomes optimized for safe and effective use, thereby preventing adverse events and improving patient outcomes.

Improving user experience

Usability stands as a cornerstone in the development of SaMD. By applying human factors and usability engineering principles, medical software becomes more user-friendly, efficient, and error-minimizing. This approach centers on user-centered design, incorporating ongoing user feedback, iterative testing, and continuous refinement. The result is software with intuitive interfaces, clear instructions, and streamlined workflows, culminating in an enhanced user experience.

Mitigating user errors

Human error is a significant factor in healthcare-related adverse events. Applying human factors and usability engineering to medical devices involves identifying potential user errors in SaMD and designing the software to minimize these risks. Strategies like intuitive navigation, clear visual cues, and effective feedback mechanisms are implemented, assisting users in making informed decisions and reducing error likelihood.

Regulatory compliance

Regulatory compliance, particularly with FDA standards, is a critical aspect of applying human factors and usability engineering to medical devices. Adhering to the FDA’s guidance on this subject is essential for market access. Compliance ensures that SaMD developers consider human factors from the early stages of development and conduct in-depth usability evaluations, aligning with regulatory expectations and enhancing overall device quality.

Applying Human Factors and Usability Engineering to Software as a Medical Device (SaMD)

Relevance of usability engineering standard - IEC 62366

IEC 62366 serves as a comprehensive framework for incorporating human factors and usability engineering into the design and 5 development phases of medical devices, notably including Software as a Medical Device (SaMD). This standard is comprehensive, advocating for a detailed, phased approach to usability throughout a product’s lifecycle, aligning with the principles of human factors engineering in medical devices.

Emphasizing the importance of early and consistent collaboration with human factors experts, IEC 62366 guides teams in understanding user interactions with the product. This collaboration is essential for creating medical devices that are intuitive and meet the varied needs of healthcare professionals, patients, and caregivers, adhering to human factors medical device standards. The standard sets out clear requirements for a structured usability engineering process, based on user-centered design. This process involves iterative cycles of user feedback and medical device usability testing, ensuring the product evolves to meet user needs effectively.

IEC 62366 also emphasized the need for detailed risk assessment, focusing on identifying and mitigating potential use errors that could impact patient safety or the efficacy of treatment. This involves analyzing real-world usage scenarios, assessing risks, and making necessary design modifications to enhance safety. This proactive approach to minimizing user-related risks ensures that the SaMD is not only effective but also safe across diverse user environments. Moreover, the standard mandates comprehensive documentation of all usability activities, serving a dual purpose: meeting FDA medical device usability guidance requirements and providing a valuable resource for internal reviews and continuous product enhancement.

By following FDA usability engineering principles, manufacturers go beyond just meeting regulatory requirements; they significantly improve the safety profile and user experience of their products. This adherence to FDA, applying human factors and usability engineering standards leads to improved clinical outcomes, enhanced user satisfaction, and, ultimately, greater acceptance and use of the SaMD in the healthcare market, but what is most important it leads to improved patient safety.

What is the process of applying human factors and usability engineering in medical device software development?

Applying human factors and usability engineering to medical devices, including Software as a Medical Device (SaMD), is a meticulous and structured process that adheres to FDA usability guidance. The first step is conducting thorough user research to understand the target users, their needs, and the context in which they will use the device. This research should consider diverse user groups, including healthcare professionals, patients, and caregivers. Based on this research, define specific user needs and translate them into actionable usability requirements.

Next, enter the design and prototyping phase, where initial concepts are developed with user-centered design principles in mind. This stage often involves creating wireframes or mock-ups of the medical device or SaMD, ensuring alignment with human factors and medical device standards. Subsequently, engage in usability testing, where real users interact with the prototype. This testing should be iterative, allowing for continuous refinement based on user feedback and observation of user interactions.

Throughout the process, conduct risk assessments to identify and mitigate potential hazards associated with the device’s use, a key aspect of human factors testing. This step ensures patient safety and meets regulatory requirements under FDA medical device usability guidance. After iterating the design based on testing and risk assessments, proceed to validation testing. This stage verifies that the device meets all established usability requirements and is safe and effective for its intended purpose.

Finally, document every step of the process meticulously, from user research to validation testing. This documentation is not only essential for regulatory compliance but also serves as a valuable reference for future improvements. By following these steps and focusing on the principles of human factors and usability engineering, medical device developers can create products that are not only regulatory compliant but also intuitive, safe, and satisfying for the end-user.

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Raising the bar for SaMD usability: 8 essential tips for human factors and usability engineering applied in mobile app for patients with tremors

So far, we’ve explored the key concepts and importance of human factors and usability engineering in medical device development. Now, let’s shift our focus to practical applications. To deepen our understanding, we’ll delve into specific tips and provide an example of how these principles can be effectively applied. For this purpose, we’ll revisit the previously mentioned case of a mobile application designed for patients with tremors.

Using human factors and usability engineering in the design of a mobile application for patients with tremors is a unique and important challenge. Tremors can significantly affect a person’s ability to interact with touchscreens, which are the primary interface for most mobile applications. Here’s an example of how this can be approached:

Tip #1: Add large, stable interactive elements

The app should feature large buttons and interactive elements to accommodate the reduced precision in touch control due to tremors. These elements need to be spaced apart sufficiently to reduce the likelihood of accidental presses.

Tip #2: Remember about error tolerance

The design should be forgiving of imprecise touches. For example, if the user attempts to press a button but touches slightly outside its boundaries, the app should still register the intended action. This reduces frustration and makes the app more accessible.

Tip #3: Create customizable interface

Considering that tremor severity can vary greatly among individuals, the app could offer customization options. Users could adjust the size of buttons or the sensitivity of touch input to suit their specific needs.

Tip #4: Allow voice commands and speech recognition

Integrating voice command functionality can provide an alternative way to interact with the app. Users with more pronounced tremors can navigate and input data using voice commands, reducing the need for precise touch interactions.

Tip #5: Add steady scroll and swipe mechanics

The app should have a scroll and swipe mechanism that accounts for unsteady hand movements. For instance, a more gradual scrolling speed and the ability to lock scrolling to prevent accidental shifts in content can be beneficial.

Tip #6: Provide visual feedback and confirmation prompts

To help users with tremors confirm their intended actions, the app can provide clear visual feedback. For example, highlighting a button when it’s pressed or offering a confirmation prompt for critical actions (like sub

Tip #7: Keep simple and clear layout

A minimalist design with a clear visual hierarchy can help users easily navigate the app. Avoiding clutter and using large, readable fonts can make the app more usable for someone with tremors.

TIp #8: Don’t forget to test with target users

Conduct usability testing with individuals who have tremors. Their feedback is invaluable in understanding the practical challenges they face and how well the app accommodates their needs.

By following these human factors and usability engineering principles, the mobile application can be made significantly more accessible and user-friendly for patients with tremors, ultimately enhancing their ability to manage their health independently and effectively.

Human factors and usability engineering provide the foundation for safe and effective SaMD development

In the Software as a Medical Device (SaMD) sector, the integration of human factors and usability engineering is essential for ensuring that medical software is both safe and effective. By comprehensively understanding user needs and capabilities, streamlining workflows, and reducing usage errors, developers can significantly improve patient safety, enhance user efficiency, and boost overall user satisfaction.

Adhering to standards such as IEC 62366 offers a methodical approach to incorporating usability engineering principles throughout the software development lifecycle. This prioritization of human factors and usability engineering enables developers to produce SaMD products that not only align with the highest standards of usability and reliability but also meet stringent regulatory compliance requirements. Ultimately, this leads to improved healthcare outcomes and a superior user experience.

Should you need specialized assistance in applying human factors and usability engineering to your SaMD development, or if you require support in navigating regulatory compliance, our team at HTD Health is ready to help. We specialize in crafting safe, user-centric, and compliant medical software solutions and are committed to supporting your journey in this vital field.

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