THAY Medical focus on the human elements of how medical devices are used. We only focus on medical devices, medical technologies and healthcare systems. We can offer expertise in one specialist area and be good at it. We offer the service of fully providing documentation and evidence of safe use of a medical device using a human factors and usability engineering methodology. We are able to perform all aspects required for regulatory compliance, from user research through to formative and summative human factors studies.
Performing human factors engineering, also known as ‘usability engineering’, is essential if a product is to be easy to use, safe to use, intuitive, effective, efficient, profitable and able to produce a positive user experience in use. These key elements are the focus of the application of the process, and can then become the outputs of the process. Human factors engineering is a process that is slightly different to usability engineering – it covers extra elements such as profitability, sociality and culture; whereas usability engineering is focused upon use performance.
The Human Factors and Usability Process
The human factors and usability engineering processes follow the same route during product development. A large portion of the process is the first stage – user research. This is the time to investigate the intended users, their capabilities and disabilities; the intended use environments and the use scenarios that the product will be used in and other unknowns. The process then moves into a design input and output stage where the user interfaces of the product are defined and initially tested out. Following this stage, the user interfaces are tested out (called ‘formative testing’) and verified, before the final user interfaces are tested out (called ‘summative testing’) and validated. Entry of the research and test data into a risk management process occurs throughout – to determine the use safety of the product.
THAY Medical are an ISO 13485-certified consultancy in ‘Human Factors and Usability Engineering’. This is rare in this industry. Our Quality Management System allows us to choose one or more regulatory processes to be used when performing human factors or usability.
For more information on THAY Medical FDA Human Factors Testing, please click here.
If you wish to read more details about the US FDA Human Factors Engineering guidance, please click here.