Understanding Human Factors for Medical Devices
What are Human Factors & Usability in Medical Devices? Informati on Perceptio n
Cognitive Processin g
Control Action
USER INTERFACE
Output
Processin g & Reaction
Input
• Human factors involve focusing on the interactions between people and devices. • The interface, handling ease, safety and rhythm of the device with the use-environment are key aspects of human factors in medical devices. • Below figure presents a model of the interactions between a user and a device, the processes performed by each, and the user interface between them. • The critical element in these interactions is the device user interface,
How to incorporate human factors during Medical Device Development? User Research It includes testing the relevance of device for the user on multiple dimensions. User Evaluation User evaluation includes studying the user demographics to get an idea about which area will be the primary user of the device.
User Validation Each of these together contribute in making a device more usercentric.
Why is Human Factor Engineering important to medical devices? Specific beneficial outcomes of applying human factors/usability engineering to medical devices include: Easier-to-use devices Easier-to-read controls and displays Safer connections between device components and accessories
More effective alarm signals, Easier device maintenance and repair, Reduced user reliance on user manuals, Better user understanding of a patient's current Reduced need foruser training and retraining. medical condition,
Better user understanding of the device's status and operation, Better user understanding of a patient's current medical condition
Things to consider while incorporating human factors in medical device:
The product must adapt to the user-environment The device should have intuitive interface Keeping it simple and relevant Keep the cost factor in mind Prioritizing safety in the medical device
Johari Digital Healthcare as India’s Preferred Contract Manufacturer Johari Digital Healthcare is a leading contract manufacturer of electronic medical devices in India. We have 40+ years of experience with low volume simple projects to high volume complex projects. Our strict adherence to US FDA and ISO: 13485 and MDSAP guidelines makes us trusted and worthy manufacturing partners in India.
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