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.
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.
User Needs to be addressed during documenting medical device usability:
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.
FAQ:
Usability engineering helps the manufacturer to assess and mitigate the usability related risks associated with the medical devices. Usability engineering helps to make sure that the user interface of medical devices can be handled by the user without any risks if used correctly.
IEC 62366-1:2015 is a standard for performing usability testing for medical devices and EN 62366-1:2015 is the harmonised standard for the same.
UOUP is abbreviated as use interface of unknown provenance. Medical device user interface which was commercialized prior to the publishing of usability standard can also comply with EN 62366-1:2015 to show up their device is safe & effective. Here manufacturer can perform a subset of activities of EN 62366-1:2015 to comply.
Steps mentioned in EN 62366-1:2015 for UOUP,
Prepare use specification
Review post-production information
Review hazard and hazardous situations related to usability
Verifying the risk control measures applied for the risk and its acceptable level
Residual risk evaluation
The output of these mentioned activities documented both in risk and usability file.
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
