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Conducting a successful Human Factors Study is critical for medical device or IVD manufacturers who want to get their product approved according to FDA requirements.
But in addition to regulatory compliance, a human factors study has other benefits: A thorough and well-planned human factors study makes it possible to improve the usability and safety of medical devices, as well as the UX.
In this article, we will highlight the best practices for conducting a successful human factors study and how it contributes to the development of high-quality and user-centered medical devices.
Enjoy the read!
1 Define clear objectives: The cornerstone of every human factors study
This involves human factors studies accompanying the development of a medical device to generate knowledge about its usability and safety so that these can be eliminated through good product design. The final evaluative study is called a Human Factors Validation Study.
A flourishing human factors study begins with clearly defined objectives. These must be specific, measurable, achievable, relevant, and time-bound.
For example, if you are developing a new medical device, the goal might be to maximize usability for healthcare professionals and minimize operating errors. This requires an in-depth analysis of user needs, the working environment, and typical interactions with the device.
A well-defined goal enables a study to be designed that answers specific questions. These could be, for example, the following questions:
- How do users perceive information on the device?
- How intuitive are the controls?
- What cognitive or physical challenges are encountered?
By precisely defining objectives, usability engineering agencies can select the appropriate methods and tools through observations, interviews, surveys, or usability tests to collect reliable and relevant data.
2 Thorough planning: the key to success
Careful planning is essential and involves selecting appropriate qualitative, quantitative, or a mixture of both research methods based on the study’s objectives.
Essential considerations include developing a realistic timeline that allows sufficient time for participant recruitment, data collection, analysis, and reporting. Keep in mind here: The more specific the user group of your product, the more difficult it may be to recruit enough participants.
Budget constraints must also be considered to ensure that all study aspects are fundable.
A well-structured plan considers potential obstacles and includes strategies to overcome them. An essential aspect of planning is compliance with ethical standards and legal requirements, especially when dealing with sensitive data or if the study poses potential risks to participants.
3 Selection of participants: A reflection of your target group
Recruiting the right participants is crucial. They should be an exact reflection of the target group of the product or system to be tested.
Their user groups must be precisely defined in terms of their key characteristics; for broad user groups such as lay users, a balanced mix of characteristics such as age, gender, experience level, and other demographic factors should be considered when selecting participants. This ensures that the study results are representative and transferable to the overall population.
It is also essential to consider factors such as the availability and willingness of participants to participate. In some cases, offering incentives such as compensation may be necessary to ensure sufficient participation.
4 Ethics and informed consent: Moral responsibility
When conducting human factors studies, compliance with ethical standards is paramount. This includes protecting participants’ privacy, ensuring voluntary participation, and obtaining informed consent.
All participants should be fully informed about the purpose of the study, the nature of their participation, possible risks, and the handling of their data.
In addition, confidential treatment of personal information should be guaranteed, and the possibility of withdrawing from the study without disadvantages should be offered. Compliance with these ethical guidelines is not only legally required but also helps to gain the trust and cooperation of the participants.
5 Realistic test environments: Closer to reality
Conducting tests in realistic environments increases the validity and reliability of the results. This means conducting the study in an environment as close as possible to the actual usage situation.
For example, tests for medical devices should take place in a clinical environment to simulate the actual working conditions of medical staff. Realistic environments help to capture authentic user behavior and interactions, leading to more relevant and applicable findings.
For example, they must also realistically reproduce background noise and other disruptive factors. Some setups, such as an operating theater, may require a well-equipped usability and UX agency that can provide all the necessary equipment and rooms.
6 Iterative tests and analyses: a dynamic process
Iterative testing and analysis enable the use of findings from previous test phases to improve designs and concepts continuously. After each round of testing, data should be carefully analyzed and interpreted to identify areas for improvement.
Adjustments should then be made to the product or system and tested again. This cyclical process allows for incremental refinement and increases user satisfaction and overall product performance.
These iterative tests are not mandatory. However, we have yet to see a medical device pass a final usability test without preparation through iterative testing.
7 Ensuring data quality: the basis for reliable results
Ensuring data quality is critical to the accuracy and reliability of study results. It would help if you took measures to minimize bias and errors in data collection.
This can be achieved through standardized testing procedures, training of researchers, and careful selection of measurement instruments. Data should be systematically collected, stored, and analyzed to ensure consistent and reproducible results.
8 Detailed and complete documentation: for transparency and traceability
Detailed documentation of the research process and results is essential. This includes recording the study methodology, participant data, testing procedures, and data collected.
Good documentation allows you to review, replicate, or build on the study. It also contributes to the transparency and credibility of the study and is an essential aspect of publishing and presenting the results to the FDA.
Your documentation of the study should be recorded in the Human Factors Report. You can find out how to create a complete Human Factors Report in this article: “Deep Dive: Human Factors Report.”
9 Communicate the results: Share your findings with the FDA in the right way
Effective communication of the results is critical to the success of the study. The results should be presented clearly, concisely and in a way that the FDA can understand.
Here, we recommend that you adhere exactly to the specifications of the appropriate guidance document. Here, too, we refer to our article: “Deep Dive: Human Factors Report“.
Conclusion
Conducting a successful human factors study is essential for manufacturers of medical devices or IVDs who want to ensure an optimal user experience and maximum safety.
Incorporating usability engineering, testing, and documentation can identify and resolve potential risks and problems early on.
The best practices presented in this article provide a solid foundation for conducting a practical human factors study.
By focusing on the needs and capabilities of users, manufacturers can develop high-quality medical devices that meet users’ needs while ensuring patient safety.
A thorough human factors study is, therefore, an essential step on the way to successful and user-centered medical devices.
Do you need help planning, conducting, and documenting your human factors study? Please get in touch using our contact form. We look forward to hearing from you.
