The WHAT, WHY, and HOW of Human Factors Usability Testing: A Key to Human-Centered Design & Development

What is Human Factors Usability Testing?

Human factors usability tests, also known as human factors or usability studies, are designed to evaluate how well a product or system is designed for human use. They are typically conducted to identify and address potential usability issues and to ensure that products are safe, effective, and easy to use.

Human factors usability studies often involve testing the product with a group of users or subject matter experts to gather information on the product's usability, effectiveness, and overall user experience. This can involve observing users interacting with the product, collecting performance and error rate data, and soliciting feedback on user preferences and needs.

Usability testing may and should be conducted at various stages of product development, from early prototypes to fully developed products. They can be used to identify and address issues that might have yet to be identified through traditional design and testing methods. Usability testing is commonly used to develop medical devices, software, and other products involving human interaction. It can also be used in designing systems and environments, such as the home, hospital systems, and workplaces, to ensure they are safe and easy to use.

Usability testing is important because it helps to ensure that products and systems are designed with the needs and capabilities of their users in mind. Companies can identify and address potential usability issues and improve the overall user experience by evaluating how well a product or system is designed for human use. Usability testing throughout the development process increases the usability, marketability, and accessibility of the final product. Additionally, for medical devices, human factors validation testing is required by US and European regulatory bodies before releasing a new medical device to the market.

Regulations Governing Human Factors Engineering for Medical Devices

In the United States, the Food and Drug Administration (FDA) regulates the development and marketing of medical devices. There are regulations that govern the conduct of usability testing, particularly when they involve medical devices or other products that have the potential to impact public health and safety. The FDA has specific guidelines for the conduct of human factors testing for medical devices, which outline the requirements for study design, participant selection, data collection, and analysis. In December 2022, the agency issued an updated draft guidance titled, “Content of Human Factors Information in Medical Device Marketing Submissions, Draft Guidance for Industry and Food and Drug Administration Staff.”

The European Medicines Agency (EMA) is responsible for regulating medical devices in the European Union. In 2021, the EU MDR became law. It addresses the requirements for the conduct of human factors usability testing for medical devices and is relevant to manufacturers, authorized representatives, importers, or distributors of medical devices in the EU. The UK Medical and Healthcare products Regulatory Agency (MHRA) also has published specific guidance on human factors usability testing.

Why is Human Factors Usability Testing Important to the Development of MedTech products?

There are several specific reasons why usability testing is important:

Safety

Usability testing can help identify potential safety issues resulting from use errors and ensure that products are designed to minimize the risk of accidents and injuries. This is particularly important in the development of products such as medical devices, where even minor usability issues can have serious consequences.

Effectiveness

Usability testing can ensure that users can effectively use products to achieve their intended purpose. Companies can identify and address any use issues that might impact effectiveness by testing products with a diverse group of users and gathering feedback on their performance.

Usability

Usability is an essential factor in the success of any product, as it determines how easily and effectively users can interact with it. Human factors studies can help identify usability issues and ensure that products are easy and intuitive.

User satisfaction

User satisfaction is important for any product or system, as it can impact customer loyalty and brand reputation. Usability testing can help to identify usability and other issues that might affect the user experience, providing opportunities to remedy these issues and increase user satisfaction.

Overall, usability testing is an important tool for ensuring that products and systems are designed to meet the needs and capabilities of their users and are safe, effective, and easy to use.

How are Human Factors Studies Conducted?

Several key elements are typically needed to run a human factors usability study.

A clear research question or objective

It is important to have a clear research question or objective that the human factors study is designed to address. This will help to focus the study and ensure that the data collected is relevant and meaningful.

Participants

Human factors studies typically involve testing the product or system with a group of participants, such as users or subject matter experts. It is important to carefully select the participants for the trial to ensure that they align with the characteristics of the intended users, considering factors such as age, gender, level of expertise, medical condition, and any other relevant characteristics. For example, a device study designed for individuals with type 2 diabetes should recruit participants who have that condition whenever possible because diabetes often causes diminished sensation in the hands and visual problems that can impact how a user interacts with the product. Further consideration should be made not only to intended users but possible users. Considering diversity and inclusion in your program is also critical to ensure that all abilities and environments are evaluated.

A test environment

A test environment should be set up that is conducive to collecting reliable and valid data. Usually, this involves simulating real-world conditions as closely as possible to ensure that there aren’t environmental factors of the environment that will negatively affect a product’s usability. For example, the alarm on an infusion pump may be easy to hear in a quiet laboratory environment but impossible to perceive among the background noise in a hospital.

Testing materials and equipment

Usability studies will typically involve a variety of testing materials and equipment, such as the product or system being tested, any necessary supporting materials (e.g., user manuals), and data collection tools (e.g., performance measures, questionnaires). Sessions are typically video recorded for analysis of use errors.

A protocol or plan

A detailed protocol or plan should be developed outlining the steps of the usability study, including the research question or objective, participant selection, data collection methods, and analysis procedures.

Data analysis tools and expertise

Data collected during the usability study must be analyzed by a qualified human factors professional to determine the root cause of any use errors or difficulties, draw appropriate and accurate conclusions, and make relevant recommendations. This may involve using specialized software or statistical analysis tools.

Human factors usability testing requires careful planning and coordination to ensure that reliable and meaningful data is efficiently collected and accurately analyzed. The information gleaned during usability testing directly impacts medical innovation and access to improved diagnosis, treatment, and care. If one of the key elements is missing or lacking, it affects the entire study.

ClariMed is helping MedTech teams design, develop, and deliver safer, more effective, and usable human-centered products.?Our world-class team has the depth of knowledge and breadth of expertise to ensure your human factors usability studies provide the usability insights to make your product successful, as well as meet the regulatory requirements.?

Contact us to learn more about our services and to discuss how we can support your company with human factors engineering and usability testing.?