Formative and Summative Usability Testing in Healthcare: The Importance of FMEA
Introduction
In 2018, we wrote a short article about Formative and Summative testing. This article is a more in-depth discussion of the different usability testing procedures for the healthcare industry. Medical products must be designed and manufactured to meet the highest standards of safety and effectiveness. Usability testing is essential for ensuring that these devices are usable, considering factors such as user needs, use environments, and use scenarios. Two types of usability testing are commonly used in healthcare: formative and summative usability testing.
What is Formative Usability Testing?
Formative usability testing is a type of testing performed during the development process to evaluate the usability of a product and identify areas for improvement. The goal of formative usability testing is to identify and resolve usability problems early in the development process before the product is released to the market. This testing is typically conducted with a small number of representative users, using methods such as think-aloud protocols, observation of user behavior, and usability questionnaires.
What is Summative Usability Testing?
Summative usability testing is a type of testing performed at the end of the development process to evaluate the overall usability of a product. Summative usability testing aims to provide evidence that the product is safe and effective for its intended use, considering factors such as user needs, use environments, and use scenarios. This testing is typically conducted with a more significant number of representative users, using methods such as think-aloud protocols, usability questionnaires, and observation of user behavior.
The FDA document “Applying Human Factors and Usability Engineering to Medical Devices” provides guidance on designing and developing safe, effective, and usable medical devices for their intended users. This document emphasizes the importance of considering human factors and usability engineering (HF/UE) principles throughout the design process, from the earliest stages of product development to post-market surveillance.
The document outlines an HF/UE process that includes several key activities, including:
- User-centered design: This involves considering the needs, capabilities, and limitations of the intended users of the device, as well as their tasks and environments, to inform the design of the device.
- Formative usability testing: This involves evaluating the device design using representative users to identify and address usability problems early in the design process before the device is finalized.
- Summative usability testing: This involves evaluating the device design using a larger sample of representative users to confirm that the plan meets the needs of the intended users and is safe, effective, and usable.
- Failure Mode Effect Analysis (FMEA): This involves identifying and assessing potential risks associated with the device, including the impact of potential failures on users and the likelihood of those failures occurring.
The Importance of FMEA
In healthcare, the use of Failure Mode Effect Analysis (FMEA) is an essential tool for identifying and assessing potential risks associated with medical devices. The use FMEA process involves the identification of possible failure modes, their causes, and their effects, as well as the assessment of the likelihood and severity of these effects.
The results of the use of FMEA can inform both formative and summative usability testing by providing a clear understanding of the potential risks associated with using the device. During formative usability testing, the results of using FMEA can guide the testing process by identifying areas of particular concern for the users. During summative usability testing, the results of the use of FMEA can be used to validate the risk levels defined in use FMEA by providing evidence of the actual use of the device by representative users in representative use environments and use scenarios.
Conclusion
In conclusion, formative and summative usability testing are essential tools for ensuring the safety and effectiveness of medical devices in healthcare. The use of FMEA can inform both types of testing by clearly understanding the potential risks associated with the help of the device. By conducting comprehensive and representative formative and summative usability testing, medical device manufacturers can ensure that their products meet high standards of safety and effectiveness, enhancing patient outcomes and supporting the regulatory approval process.
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