It is also called as Human Factor engineering as it deals with the application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve sufficient usability.
Usability engineering deals with the 3 important factors like user, user interface and use environment associated either with the safe and effective use or unsafe and ineffective use of the medical device.
Why Medical Device Usability Testing Matters
Medical device usability testing is crucial to ensure that devices are safe, effective, and user-friendly for both healthcare professionals and patients. Poor usability can lead to user errors, posing serious risks to patient safety. By integrating medical device usability engineering early in the development process, manufacturers can identify and mitigate risks associated with human interaction. Usability engineering medical devices focuses on optimizing user interfaces, minimizing cognitive load, and enhancing efficiency. Conducting medical device usability testing under real-world conditions helps in refining the design, ensuring compliance with EN 62366-1:2015, and improving overall device reliability. Effective medical device usability engineering leads to safer and more intuitive medical devices.
Enhancing user experience and safety
Enhancing user experience and safety in medical device usability engineering is crucial for ensuring intuitive operation and minimizing risks. A well-designed user interface improves efficiency, reduces errors, and enhances patient safety. Usability engineering medical devices focuses on optimizing device interaction through rigorous medical device usability testing and risk assessment. By integrating ergonomic principles and regulatory compliance, manufacturers can develop reliable and user-friendly medical devices. Continuous usability evaluation, feedback collection, and adherence to EN 62366-1:2015 help in refining designs and improving user satisfaction. Prioritizing medical device usability engineering leads to safer, more effective medical devices that meet industry standards.
Meeting regulatory requirements
Meeting regulatory requirements for medical device usability is essential to ensure compliance with standards like EN 62366-1:2015. Manufacturers must document usability engineering processes, conduct risk assessments, and implement design controls to minimize user errors. Proper usability testing enhances safety, efficiency, and compliance. Adhering to usability standards ensures that medical device usability meets regulatory expectations, reducing hazards.
Improving device performance and adoption
Enhancing medical device usability improves performance, user satisfaction, and adoption. A well-designed user interface reduces errors, enhances safety, and ensures seamless integration with healthcare systems. Effective usability engineering mitigates risks, supports regulatory compliance (EN 62366-1:2015), and optimizes user interaction. Key factors include intuitive design, human factors engineering, usability testing, risk management, and real-world user feedback to refine medical device functionality.
Medical Device Usability Goals:
- Design a medical device that is intuitive and easy to use for both medical professionals and patients.
- Ensure that the medical device is safe for use in a medical setting.
- Ensure that the medical device is compliant with all applicable regulations and safety standards.
- Design the medical device in such a way that it is durable and reliable.
Medical device usability testing
Performing Medical Device Usability testing helps the manufacturer to assess and mitigate risks associated with actual and incorrect use due to user errors.
Medical Device Usability is defined as the characteristic of user interface which facilitates the use and establish effectiveness, efficiency and user satisfaction in the intended use environment.
- Conduct user interviews and surveys to determine user needs and preferences.
- Test the medical device with various medical professionals and patients to evaluate usability.
- Test the medical device in different conditions to evaluate its reliability.
- Test the medical device for its ability to accurately measure, diagnose and monitor patient’s vital signs.
- Test the medical device for its ability to connect to other medical equipment and software systems.
- Test the medical device for its ability to provide easy-to-understand results.
- Evaluate the medical device’s ergonomics and comfort.
- Test the medical device for its ability to be easily cleaned and maintained.
- Test the medical device for its ability to be easily transported and stored.
Key Performance Criteria for Medical Device Usability and Reliability
- The medical device should be able to accurately measure, diagnose and monitor patient’s vital signs.
- The medical device should provide easy-to-understand results.
- The medical device should be able to connect to other medical equipment and software systems.
- The medical device should be able to operate in a variety of conditions.
- The medical device should be easy to clean and maintain.
- The medical device should be easy to transport and store.
Design Guidelines to ensure medical device usability:
- Design the medical device to be user friendly and intuitive.
- Ensure that the medical device is ergonomically designed for maximum comfort and usability.
- Design the medical device to be compliant with all applicable regulations and safety standards.
- Ensure that the medical device is durable and reliable.
- Ensure that the medical device is easily cleaned and maintained.
- Design the medical device to be easily transported and stored.
- Design the medical device to integrate with other medical equipment and software systems.
- Design the medical device to be able to operate in a variety of conditions.
- Design the medical device to provide easy-to-understand results.
- Design the medical device to provide accurate measurements and diagnosis.
Medical Device Usability Engineering Process
Medical Device Usability engineering process helps manufacturer in identifying hazards and hazard related to user and user interface, applying and evaluating the risk control measures related to user interface which further provides safety to patient or user.
Following are the process involved in usability engineering
- Prepare use specification
- Identifying device primary operating function
- Identify known or foreseeable hazards and hazardous situations
- Identifying hazard related use scenarios
- Select hazard related use scenarios for summative evaluation
- Establish user interface specification
- Establish user interface evaluation plan
- Perform user interface design, implementation and formative evaluation
- Perform summative evaluation of the usability of the user interface
Manufacturer who wants to be complied with EN 62366-1:2015 for user interfaces if medical devices which has been commercialized prior to 2015 i.e. prior to establishing the usability standard, those device comes under user interface of unknown provenance (UOUP).
If any design changes in the presence of UOUP, then manufacturer shall follow all activities of EN 62366-1:2015 for changed parts of the medical device.
