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Applying human factors and usability engineering to medical devices

Author: Tara Miller | Date: November 16, 2021

Human factors (HF) and usability engineering (UE), or as some call it, medical ergonomics, is the process of evaluating and changing the design of a device to better fit the human body and its cognitive abilities. The FDA defines it as “the application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users to the design of medical devices including mechanical and software-driven user interfaces, systems, tasks, user documentation, and user training to enhance and demonstrate safe and effective use.”

 Human factors and usability engineering is a crucial consideration in the development of safer and more effective medical devices for end-users. Think about it: a medical device is only as good as the human being’s willingness and ability to use it. By applying human factors and usability engineering to the design and development of your medical device, you will minimize user error and, ultimately, human harm.

While human factors engineering guidelines have been in place for the automotive, aerospace, and telecommunications industries for more than 60 years, they have only recently become available to the medical industry. As usability-induced adverse events continue to rise, the FDA has taken notice, and now includes HF/UE reviews as a routine part of their pre-market approval process.

Despite the FDA’s human factors guidance, many medical device companies fail to consider usability at the beginning of the development process—a costly and damaging mistake. By incorporating human factors and usability engineering throughout all phases of device design, medical device companies can understand and mitigate potential sources of device risk and design an interface that promotes correct, error-free use of the device without endangering the user.

How to apply human factors and usability engineering to your medical device design:

HF and UE is not a check-the-box activity that can be thrown in last minute; it requires a methodical approach that considers a range of elements across the entire product development lifecycle, including:

  • Research to understand which factors control the quality of user interactions as they relate to a safe, usable, and efficient product
  • Analysis of the mental and physical interactions with the product, as well as users’ mental models, workflows, and needs.
  • The application of the above elements to design a device that meets the functional and aesthetic goals.
  • Formative and summative usability testing to evaluate the design’s usability throughout the design and development process.
  • Validation of the device design through comprehensive simulated use testing.

Each of the above activities plays a crucial role in applying human factors and usability engineering to your medical device, but they cannot be done in silos. A well-defined human factors and usability process is multi-functional in nature and requires expertise that spans the entire product development lifecycle.

At Sterling Medical Devices, we have decades of experience applying human factors and usability engineering to medical device development. We’ll help you design medical devices that are safe for customers and offer a positive user experience.

Leveraging testing, development, and design expertise, we’ll help you ensure that your medical device considers all aspects of human factors engineering and usability throughout the design process, which will ultimately mitigate risks and save time in other phases of your development.

For more information about how to apply medical device human factor engineering to your process, contact us here.

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