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The human factors or usability engineering procedure minimizes user-related risks and hazards and verifies that the process was effective and that users can successfully and safely use the device. Human factors considerations are a crucial and needed part of the risk management process you, a medical device manufacturer, can use in your design controls to prevent and reduce any hazards associated with the use of your medical device.
While expecting usability issues in the early development stages can be challenging, applying human factors testing in advance and regularly is essential to informing risk management. Here are six considerations for human factors testing for your medical devices.
The project that tests and validates human factors must mimic real-world circumstances. If a test needs members to be trained in the correct technology, imitating the actual setting in which the device will be used is essential. If the device is used at home, a hospital's overly bright-lighted and sterile setting won't precisely represent the actual usage environment.
Consider all the features, including noise, lighting, temperature, and vibration, of the situation in which the equipment will be used. Improvita, A Human Factors company, and other such companies have medical device testing labs that simulate the proper testing environment based on the product's use. This helps meet user needs.
Identifying your device's potential users can help your risk management process. Consider the consumers who might use the equipment without knowing its dangers or those who cannot safeguard themselves from possible threats. A user's capacity to use a medical device can be informed by their personal traits, including sensory abilities, general health condition, the health problem for which the device is being used, cognitive abilities, emotional and mental condition, linguistic and literacy abilities, and physical size, strength, and stamina. While these elements might not apply in all situations, considering the device user and testing for usability in various scenarios and among different users is essential.
For you as a medical device manufacturer, unearthing use errors may be the most horrifying result of your human factors research. This is why you should develop user-friendly devices to reduce user error risks. With task analysis, you can assess user-device interactions to understand the factors affecting use errors. Through this process, you can predict how users interact with and perceive medical equipment in a given context, letting your design team foresee where use errors may occur and the harm they might cause.
To create a task analysis, first, understand the various device use cases to inform simultaneous and sequential tasks' breakdown needed for effective use. Set top-level device-user interaction functions and then create a task list for the user interactions needed to finish the functional factor, and then define sub-tasks for discrete actions the user should take.
The device's user interface consists of all interaction points between the user and the device throughout setup, use, maintenance, and disposal. These may include the medical device's weight, size, and shape, the pattern in which details are delivered to users, including feedback, labeling and packaging, and indicator lights, displays, and auditory and visual lights which provide users with information.
You should find a way to eliminate or reduce the use-related risks of your medical devices. Develop an intuitive device design to ensure that the indicators and controls are easy to use and understand without requiring in-depth instructions or training. You can include safety guidelines in your design to ensure clear use. Consider using standard conventions and symbols like OFF and ON for switches to help users learn the equipment's indicators and controls and ascertain that user interfaces are easy to understand and use, reducing the risk of errors.
Installing safety measures on your medical devices, such as using alerts for risky conditions that may threaten a patient's safety, clearly labeling all indicators, displays, and controls in an easy-to-read and understand way while accurately reflecting their function, and implementing error detection and prevention measures can help reduce or avoid equipment risks. Adding training and safety information can also help ensure medical device safety and efficacy.
Formative testing enables your medical product development team to know more about the devices they're developing, particularly through the end users' lens. Its purpose is to place user preferences and needs in the middle of the design team's choices from the development process's early stages. Formative testing allows you to tailor your medical devices more perfectly to meet users' needs. While there isn't a set formative testing structure, conducting these evaluations in the intended environment can yield excellent results.
Formative usability tests during medical product development help minimize the risk of creating the wrong and hazardous product. They offer insights to establish solutions that address users' needs and enhance outcomes. Formative usability evaluations minimize medical device errors and improve the overall user experience. They show and qualify that solutions can proceed to the next development phase.
Human factors testing reduces the risk of hazardous errors in your medical products. Consider implementing these considerations for human factors testing for your medical device.
