Human factors and system thinking for medical device

The main role of human factors and ergonomics professionals within health care is to generate evidence to support the development and the redesign of services and products. To achieve safe and resilient health system environments, both technology and people should collaborate in a resonant way by ensuring an optimal experience to patients. Human factors and ergonomics methods of investigation aim to generate evidence to inform decisions about appropriate selection of a device, processes resilience, human reliability, and safety of healthcare processes and products. Clinical settings are continuously changing and evolving. Human factors and ergonomics bring in the clinical engineering team a systems thinking approach that could be used to map the context of use and to inform about the operational costs and barriers associated to the use of device in the field—e.g., time to perform, time to obtain the results, time for decision-making, people involved in the process and stakeholders, etc. These analyses may add nuances to gray areas which are usually only partially informed by premarket research and add to health economics evaluation. In line with that, human factors and ergonomics methods are essential tools to define, model, and evaluate the value added by a new product or service in the health environment and to engineer, during the development, the value of new solutions.