Human Factors Consultant
Human factors, also referred to as ergonomics, human engineering or usability research, is the scientific discipline that applies theory, principles, data and method to design in order to optimise how humans behave physically and psychologically in relation to particular environments, products, or services.
A human factors consultant is a subject matter expert (SME) who will be employed to oversee all aspects of human factor concerns and usability data for any design, including medical devices. Human Factors Consultants will typically have a background in either philosophy, anthropology, psychology or design engineering prior to progressing into Human Factors. Using design ethnography to immerse themselves in the real-life constraints/problems/issues of the end user, Human Factors consultants will consult on design to improve user acceptance and overall usability of the end product. Human factors considerations are applied through out the design process from initial concept, prototype, design, assembly and testing to ensure that the product is not only efficient and safe, but also usable. Limitations of the patient group in question are introduced as part of this, for example devices for measuring blood insulin levels may be used by patients of all ages, from children to the elderly and need to be easy to use across the board.
The human factors consultant will oversee the project and work with a variety of engineers, researchers, designers, clients and project managers to ensure appropriate data collection and its application to the design project as a whole. The FDA have now included human factors as a mandatory part of their approval process for medical devices in the US. The MHRA is reported to be following suit in the coming months. Since the change in legislation in the States over 500,000 devices have been declined for regulatory approval due to weak or incomplete human factors data. Highlighting how important the work completed by the Human Factors Consultant is to the overall success of the project.