Usability engineering- also known as human factors engineering- is focused on designing medical device interface allowing people to interact with the product in the most efficient and error-free way. When we call a product is “intuitive” or user friendly” we are actually referring to its usability.
The main goal of usability is to design the interface of medical device keeping the intended users in mind and reducing as far as possible the use error associated with the device. It is important as many times we overlook the user interactions with the device and reduce the risks associated with perhaps the device material, biological concerns, safety etc. while some of the adverse events happen because of use error as well meaning the device outcome was different than what was anticipated but not due to device malfunction.
Usability Standards
IEC 62366 is the international standard that covers application of usability process on medical devices. It has two parts:
⦁ IEC 62366-1: Application of usability engineering to medical device
⦁ IEC 62366-2: Guidance on the application of usability engineering to medical devices
In case of electrical or electronic medical device, IEC 60601-1-6 is also referred too.
The clauses and required detail mentioned in the above standards can be customized based on the design and type of your medical device.
Usability Process
IEC 62366 describes a process to mitigate the risks associated with the correct use and use errors due to usability problems. The process is as followed:
⦁ Prepare use specifications
⦁ Identify frequently used functions
⦁ Identify known or foreseeable hazards and hazardous situation
⦁ Identify primary operating functions
⦁ Develop usability specifications
⦁ Prepare usability validation plan
⦁ Design and implement user interface
⦁ Verify user interface
⦁ Validate usability of medical device
⦁ Develop usability engineering file
