A human factors validation study can test the effectiveness of a product or process. It should be performed using a constructive approach rather than a retrospective evaluation. A human factors validation study should also include the effects of a product’s design on its users. Formative studies are essential for the improvement of design quality and safety, as well as for reducing product recalls.

Formative human factors study

A formative human factors validation study is an early round of user testing. The primary audience for such a study is the FDA. However, the audience can also be a small development team, a consultant-client contract, or the CEO of a company. Identifying the intended audience before the study begins is crucial because a product development team will likely require more information than the CEO. In contrast, a CEO may only need an executive summary.

A formative human factors validation study is a critical step in the process, as it prepares the design and development of a new product. While formative research may be expensive and resource-intensive, it can also yield negative results that will be useful when conducting human factors validation testing. For instance, if a formative study produces results that are less than positive, the company can adjust the design and create a better product.

A formative human factors validation study design begins with changes in the self. These changes become the basis of the validation study. In addition, these inputs are equivalent to the components of the device. Formative research is essential because the FDA mandates constructive human factors activities before validation testing can begin. By designing the test and conducting the human factors activities in parallel, the chances of a successful validation study increase.

Before the human factors validation study, the marketing team developed plans for a new device. Then, they observed similar devices in patients’ homes and hospitals. Finally, they took notes from these observations, which guided their decision-making regarding the type of user group and the study environments. Ultimately, this research helped the company launch a new product that was safe, effective, and affordable. And it provided a valuable insight into the design of a human factors study.

This human factors validation study focused on the design of an autoinjector, which is used by a group of patients, healthcare professionals, and lay caregivers. The participants included naive patients and those with experience. The participants included people with dexterity issues, multiple sclerosis, and hand impairments. Several participants had disabilities that affected their ability to use a syringe.

The three major formative studies were conducted in France and the US. Single one-on-one testing sessions were completed. In each, participants performed simulated injections on mannequins. The healthcare providers and caregivers held foam pads on figures on which they could simulate injections. The testers evaluated the force and time required to keep the autoinjector on the pillow. The rates of usage errors gradually decreased over time, and the design was tweaked to optimize its usability.

FDA human factors guidance describes the process of conducting a usability study for a medical device. It emphasizes the importance of identifying critical tasks, using scenarios, and incorporating instructional materials. In addition, the FDA encourages sponsors to submit their draft human factors validation testing protocol so that the methods used are acceptable. As a rule, human factors engineering is the best way to prepare devices for usability studies. This means designing the product with the user in mind at every stage and building design elements to mitigate potential risks.