Human factors Engineering (HFE) use behavioural scientific methods to identify possible design flaws of human device interaction, due to the (sometimes) unpredictability of the human behaviour. It is difficult to rely on logic or intuition alone, with the design of man/machine interactions and human factors provides the means of research and analysis to discover valuable solutions.
HFE is the science of solving issues regarding the integration of humans into machine systems. It hereby focuses on the interactions between people and devices in terms of vision, touch, hearing and cognition; how does the users prepare to interact with the device? (e.g. unpacking and set-up); and how does one use the device, or perform maintenance? (e.g. cleaning and making repairs). HFE use behavioural scientific methods to identify possible design flaws of human device interaction, due to the (sometimes) unpredictability of the human behaviour. It is difficult to rely on logic or intuition alone, with the design of man/machine interactions and human factors provides the means of research and analysis to discover valuable solutions.
The growing complexity of products can lead to interaction and usability problems. Advanced technology has created entirely new problems related to the human operators and the way humans can be integrated into systems. These problems can only be solved by addressing the whole context and therefore HFE is necessary to prevent harmful use errors, especially within the medical field. For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks. Once it has been confirmed that HFE efforts were successful in this endeavour, a device can be implemented in the commercial market and be used safely and effectively. Specific beneficial aspects of applying human factors to these medical devices include:
- Easier-to-read controls and displays,
- Better user understanding of the device’s status and operation,
- More effective alarm signals,
- Reduced need for user training and retraining,
- Reduced risk of use error,
- Reduced risk of adverse events.
HFE applies to a wide range of medical devices. This includes combination products, like auto-injectors or nebulizers; therapeutic and diagnostic devices, such as insulin pumps and ultrasound scanner; critical care devices such as defibrillators; and lab instruments such as blood analysers. All these vary in complexity and risk, which can lead to interaction problems that influence the usability of the product and its safety.
It is important to state that HFE does not neglect product appeal. An appealing product has been proven to increases user satisfaction, engagement and usability. Appealing design can enhance motivation to use the design and comfort especially for children. Therefore human factors consider the appeal of the product as important, although this may never compromise the safety and effectiveness.
The activities that involve HFE include both research and analyses. On the research side, specialists perform field observations, which consists on examining the devices’ operation in the actual context wherein they are used. They carry out interviews with medical professionals, patients, or any other stakeholders; and surveys. The other aspect of HFE includes anthropometrics analysis, which can ensure the correct ergonomics of the product to improve its usability and efficiency. Through various analysis techniques adverse events and hazards related to user risks are identified.
Another main activity of HFE is evaluation and usability tests. Formative testing is carried out during the development cycle of a product. It consists of getting as much feedback as possible from the user in order to improve the device and to compare it to other design alternatives. Summative testing is conducted for the final validation of the product, which approve its performance (safety and effectiveness) and is necessary for FDA approval of new medical products.