The Human Factors/Usability Engineering process culminates with the execution and reporting of a Human Factors Validation study. Formative Testing precedes Human Factors Validation and provides an early assessment of risk and use-related risk mitigations. Following a successful Formative study, the Human Factors Validation study is then conducted to formally confirm the user interface can be used in a safe and effective manner by the intended users, and for its intended uses. Additionally, the final report should include a discussion of the product benefits relative to residual risks.
Learn more about Human Factors Validation and how Improvita can guide you through the process.
There are three phases in conduct of Human Factors Validation Testing: Study Preparation, Study Execution, and Study Reporting.
In the study preparation phase, the intended users, use scenarios, and use environment are researched and identified to develop an in-depth understanding of how the users interact with the product.
Once the intended users, uses, and use environments are defined, the Human Factors risk management process can be initiated. A task analysis should be utilized to identify how the user will interact with the product, including their perception of the steps, their thought process, and how they will physically engage with the design.
Task analysis creates a foreseeable sequence of events, which can identify what is known as a hazardous situation. A hazardous situation according to the FDA is a circumstance in which people, property, or the environment is/are exposed to one or more hazard(s).
The hazardous situation will drive the risk management process to identify the hazard the user may be exposed to, which is the potential source of harm. According to the FDA, harm is defined as injury or damage to the health of people, or damage to property or the environment. There are varying degrees of severity of harm, and the severity must be determined by a medical professional.
The resulting severity of harm will drive identification of task criticality. A critical task is defined by the FDA to be a task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care. The severity of the harm, in conjunction with an estimated probability of occurrence the hazardous situation is to occur (often determined by a medical professional and the results from a known use errors analysis), results in determination of use-related risk.
As the Human Factors Validation study protocol is prepared, any previous Human Factors inputs are reviewed. This includes the review of Formative Evaluations conducted earlier in the Human Factors/Usability Engineering process which may explore the user interface design strengths, weaknesses, and unanticipated use errors. The results of the Formative Evaluation are incorporated into Human Factors risk management deliverables to finalize critical task determination before the Human Factors Validation Protocol is finalized.
Once the risk management documents have been updated following the Formative Evaluations and task criticality has been determined, all necessary inputs are in line to finalize the test protocol. These items have a significant impact on content such as task sequencing, success criteria, participant eligibility criteria, and moderator questions. As a best practice, the finalized protocol should be submitted for review by the FDA to gain concurrence on the test population and the protocol.
Recruitment of study participants who have the defined intended user attributes is central to the success of the study. To secure the full complement of users it helps to have a strong recruitment team who understands the unique population and their needs.
During study execution, the participant’s response and task performance is carefully monitored by a moderator. A trained observer from the study team may also act as a data collector. Once the tasks and scenarios have been completed, the moderator and/or observer may ask the participant questions about their interactions with the product, their knowledge of the important information about use of the product, or general feedback on the product.
Upon completion of the Human Factors Validation study, all study data, including performance against acceptance criteria (use errors, close calls, and difficulties), is subject to a robust root cause analysis. These results, together with supporting statistics, are summarized in the Human Factors Validation report.
Study reporting requirements vary slightly based on criticality of the medical device, and between medical devices and combination products. Generally, reporting a Human Factors Validation study should follow the FDA draft guidance Content of Human Factors Information in Medical Device Marketing Submissions:
At Improvita, our team of experts brings extensive experience in Human Factors Validation Testing, guiding you through every step of the process. We are committed to complying with regulatory requirements and our focus is on user-centered design. We will help you minimize risk and enhance the overall user experience, ultimately leading to safer and more successful products.
To learn more about Improvita’s Human Factors Validation consulting services, contact us to discuss your specific needs
