Aran R&D is set to offer Human Factors Engineering services to deliver regulatory-approved,
market-oriented products.
Human Factors Engineering – a Must Do
In order to design safe and effective medical devices, it is essential to consider the users’ needs and capabilities. This understanding led FDA and CE to set the industry’s new human factors and usability engineering standards and requirements purposed to minimize user-related hazards and risks.
Early HFE Contributes to Lean R&D Process
Human factors engineering includes various tools, that if used correctly throughout the process, can reduce development time and cost. The idea is to identify potential use errors and use-related hazardous situations early on and implement the required changes before significant efforts are spent on detailed design.
In addition to the analytical tools such as task analysis and use-related risks management, it is highly recommended to use empirical tools such as user testing and cognitive walk-through as well. Users will always surprise you! This is why the most effective way to identify “weak spots” in the user interface is by conducting early user testing. It doesn’t have to be a complex or expensive production, even testing a basic prototype or a simple mock-up with a small group of proxy users can provide insights that may have been otherwise overlooked.
Arans’ Comprehensive HFE Services
Most medical products include both digital and physical user interfaces. To address the multidisciplinary challenge, Aran has assembled a team of experts: human factors engineers, cognitive psychologists, industrial designers and user experience specialists, all working closely together with our mechanical, electrical and software engineers, to cover all usability aspects.
Aran’s Human Factors and usability engineering services are offered as standalone services or as part of a development project.
Services include Human factors and usability plan, user research, task analysis, use risk analysis, user interface design inputs, formative and summative testing, HFE/UE report preparation, regulatory consultation and preparation for submissions.
Join our live webinar on January 15th to Learn More!
You are invited to join our live webinar: “Leverage FDA Human Factors Guidelines to Enhance Your R&D Process” that will review effective ways to implement human factors and usability engineering in the medical device design process.
To register, click here.
