When it comes to the design of medical devices, the stakes are high – when errors occur, they can lead to life-changing injuries and even death.
Human Factors Engineering (HFE), or usability engineering, focuses on the interactions between people and devices and ultimately, aims to enhance patient safety by minimising use-related hazards.
Using examples from Haughton Design, a medical device design & development consultancy designing for clients in the Pharmaceutical and Healthcare sectors, Senior Design Engineer, John Harverson, and Human Centred Designer, Amber Davies, wrote an article on the importance of Human Factors Engineering (HFE) in Medical Device Development for Engineering Designer, a quarterly journal from the Institution of Engineering Designers.
The article discusses a variety of activities and procedures within the Human Factors Engineering process for medical device development such as Fault Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA), regulatory requirements and design controls.
