Applying a Human-Centric Approach to Medical Device Design
Ensuring that products are safe, effective, and user-friendly when designing medical devices is crucial. Human-centered design (HCD) offers a framework for achieving these goals by placing the user at the center of the development process.
With over 65 years of experience and a 100% success rate with FDA submissions related to human-centered design, Battelle offers expertise in aligning medical devices with industry best practices.
Join us as we explore HCD, from its foundational principles to its practical applications in medical device design.
What is Human-Centered Design (HCD)?
Human-centered design is a product development approach that focuses on how the user can, know, and want to perform tasks. It emphasizes understanding user needs, behaviors, and the use environment to ensure that the design process and the medical device align with user capabilities and expectations.
What are the benefits of HCD?
An HCD approach ensures that devices are safe, effective, and meet user needs. It focuses on building devices for users, aligning with their behaviors, and adhering to industry guidelines, ultimately enhancing both user satisfaction and product reliability.
When should HCD be applied in the device design process?
HCD should be applied early and often throughout the device design process. Conducting user research and iterative testing from the beginning helps identify potential use errors and design issues, allowing for timely adjustments and improvements.
Who should be involved in a human-centered design approach for medical devices?
A human-centered design approach should involve a cross-disciplinary team, including medical deviceexperts, engineers, designers, regulatory specialists, and users such as patients, caregivers, and healthcare professionals. This collaboration ensures a balanced approach and fosters successful product adoption.
How can HCD help devices meet industry standards and regulatory requirements?
HCD is crucial in helping devices meet industry standards and regulatory requirements by embedding human factors and usability engineering principles throughout the development process. The user-centric approach helps ensure devices are intuitive and user-friendly, thus minimizing use errors that could compromise safety. HCD aligns with standards including ISO 13485:2016 for Quality Management, ISO 14971:2019 for Risk Management, and IEC 62366:2015 for Usability Engineering. Rigorous usability testing and iterative design provide evidence of safety and effectiveness for regulatory submissions, while comprehensive documentation supports compliance and facilitates smoother regulatory approval.
How can an HCD approach capture user needs and requirements and gather iterative feedback?
Teams can use contextual research and iterative design to capture user needs and requirements. By immersing designers in real-world environments, observational studies and cognitive interviews reveal users' daily challenges and expectations. This research informs the creation of user personas and scenarios, guiding design decisions. Prototyping allows for user testing and evaluation, gathering feedback on usability and functionality.
Regular feedback loops ensure continuous refinement, aligning the device with user expectations. Co-design workshops can engage users in generating ideas, fostering ownership, and ensuring the product reflects their needs. As the design progresses, usability testing validates that the device meets user requirements. Capturing detailed documentation of the research, design decisions, and feedback can ultimately support regulatory submissions and future iterations.
How could HCD help ensure safer medical devices?
HCD anticipates potential use errors by identifying and analyzing critical tasks—specific user actions that, if executed incorrectly, could lead to serious harm or compromised medical care. This process begins with comprehensive user research to understand the context in which the device will be used, including the variability of users, their mental models, and the environments they operate in. By mapping out these critical tasks, designers can pinpoint areas where errors are most likely.
Iterative design and testing are crucial in this approach, allowing designers to create prototypes and conduct usability testing with real users. This testing provides valuable insights into how users interact with the device, highlighting potential errors and usability issues. By continuously refining the design based on this feedback, HCD minimizes risks, enhances safety, and ensures that the device is intuitive and reliable for its intended users and environments.
How can HCD help to ensure a device meets user needs?
Usability testing is a cornerstone of HDC, crucial for evaluating a product's effectiveness, efficiency, and user satisfaction. It involves observing real users interacting with the device in simulated and real-world environments, offering insights into actual performance. By capturing data on user interactions, usability testing identifies issues like non-intuitive interfaces, design flaws, and dexterity challenges that could impede task completion. Early formative studies assess the device's user interface and guide iterative design improvements. As the design matures, summative usability testing ensures that the device is safe and effective for users.
How can HCD be used to improve training and instructions for use effectiveness?
By tailoring instructions to real user needs, HCD ensures that training is practical and impactful. The emphasis on iterative feedback allows for continuous refinement of training materials. This approach keeps training relevant and effective, providing clear guidance to reduce errors, boost user confidence, and improve device safety.
After launch, post-market surveillance monitors real-world use to identify emerging issues, allowing prompt adjustments.
At Battelle, our cross-functional team of designers, cognitive psychologists, scientists, and engineers specialize in applying human-centric design to create devices designed for the real world. Connect with us to learn how we can help bring your devices to market with confidence.
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