Enhancing Patient Outcomes through Human Factors Studies: Improving User Experience 

by Gilero October 2, 2023

What is Human Factors Engineering? 

Human factors engineering is a critical part of the medical device development process. The earlier issues are discovered and addressed, the better it is for the future of your product. Human factor engineering is a design approach that focuses on how systems take into account human interactions. It attempts to optimize safety and minimize user error in complex environments. When it comes to design and development, human factors engineering focuses on optimizing the interactions between the user and the device. It is vital to understand all the ways that the user perceives the device and its components. Then, it’s important to observe how they interpret the information and make decisions on how to operate the device. 

What are Human Factors Studies? 

There are two types of human factors studies: “summative” and “formative.” Summative studies are used to validate the final design and confirm that the device’s user interface meets the needs of its intended users. Formative studies are conducted early in the development of the product. A summative evaluation focuses on deciding which parts of the device work, and which need redesign. They are used to inform the developers of issues early so that they can modify and test the device until they are confident that the device will work appropriately. Human factors studies ensure that the device is as safe and effective as possible.  

Benefits of Applying Human Factors Engineering in Healthcare 

The application of human factors engineering for your device before production can be one of the most important investments of the project. It can help improve the usability and user experience of the device. When usability is prioritized, the safety and effectiveness of the device increases, and there is a smaller chance of complications and hazards related to the user interface. When healthcare workers are well informed, and the device is built with them in mind, there is an increase in workflow efficiency and optimization.  

Collaboration between Human Factors Experts and Healthcare Professionals 

A healthcare professional’s performance with the device is imperative to the impact of patient safety.  Therefore, collaboration between human factors experts and those in the real- world setting is fundamental in designing the user interface. To help eliminate risks, it’s important to recognize how different factors such as stress and burnout can impact the way they think and carry out their patient care. With collaboration between both parties, it makes finding an approach to account for specific environments more educated with all parties in mind.  

How can Human Factors Improve Patient Outcomes? 

The most important goal of human factors engineering is to enhance patient safety and minimize use-related hazards and risks. It is imperative to mitigate any possible user errors from the device that could lead to the patient experiencing any further harm. A human factors approach is the key to safer healthcare, as the occurrence of preventable medical errors is the third leading cause of death in the United States. Attempting to reduce medical errors through human factors studies is critical to consider while developing your medical device. Performing human factors testing on your device gives insight into the impact of inadequate knowledge, stress, and poor communication on the healthcare professionals that are intended to use the device. Developers cannot expect that every user will know exactly how to operate their product correctly, especially in times of pressure and intensity. Therefore, human factors in healthcare authorizes improvement in patient safety and satisfaction as well as clinician burnout and efficiency.  

Gilero Human Factors Capabilities 

Human-centered design is core to our design and development process. Gilero uses human factors engineering to improve the design of medical devices and combination products, ensuring they can be operated safely in real-world conditions. We conduct user research early on to collect actionable data that can be applied to your medical device design and provide guidance all the way through regulatory submission. With the availability of our on-site human factors observation suite, we help our clients deliver devices to market that are not only safe and effective but are also more likely to be a commercial success. 

Gilero offers a range of Human Factors Services, Including: 

• HFE planning 
• Contextual inquiry 
• Focus groups 
• Anthropometry 
• Ethnographic research 
• Heuristic analysis 
• Participatory design sessions 
• Task analysis 
• Use-related risk analysis (URRA) 
• Use failure modes and effects analysis (uFMEA) 
• Formative usability studies 
• Summative usability studies 
• Label comprehension studies 
• Comparative analysis 
• Threshold analysis 
• Instructions for use (IFU) 
• HFE/UE summary reports 

About the Author

Gilero Gilero specializes in the design, development, and contract manufacturing of medical, drug delivery, and diagnostic devices, bringing innovative healthcare solutions to market. The team combines engineering expertise with a deep understanding of regulatory requirements.