As medical devices become more complex, the FDA and other international compliance standards including ISO 13485 continue to place greater emphasis on ways to improve the safety and effectiveness of products prior to commercialization. Human Factors Engineering (HFE) and Usability Testing are based on a user-centered design which includes critical elements of the development process and is used to ensure devices meet or exceed compliance regulations. To meet FDA expectations, manufacturers seeking device clearance in the US should ensure adherence to HFE guidance and prioritize usability testing.

Usability testing and other user interface evaluation methods are a critical part of the device design and development process and can be divided into two major categories:  formative and summative testing. Both are equally as important and each type of testing is implemented during different phases of the design cycle.

Formative Testing

Formative usability testing comes early in the design phase, but after your team has deployed appropriate analytical approaches to early-stage design. This testing is typically done with early prototypes and shapes the design for the end-user experience. This testing provides valuable insight; for example, highlighting areas in which users may have difficulty reaching product use goals. It is critical to observe and understand users thought processes and their actions during this phase. As new prototypes are developed based on formative testing, new user studies should be completed for each iterative prototype until the product has been finalized.

Output and data gathered from formative testing are highly qualitative. The information recorded can include things like user feedback about confusion or misunderstanding of instructions or functions, perceptions of the product interface or design and suggested iterations for fixes. This data is extremely useful to discover insights and shape design direction.

Summative Testing

Summative usability testing is a quality assurance (QA) process used during the latter half of the development phase, typically testing with working prototypes. This process is important to measure and validate the usability of a product and to compare against competitive products or usability metrics.

Final validation data gathered will be used to demonstrate that risks have been identified, mitigated and are adequately addressed. This is a disciplined data collection process and is based on scientifically gathered, reliable data. Summative testing for the FDA requires at least 15 members in a test group. Outcomes of this type of testing will generally be progressively statistical so the larger the test group, the more accurate the resulting data will be.

Human Factors Validation and Usability Testing related to medical devices or other scientific instruments are without a doubt one of the most critical elements of successful medical product development and design. Specific device requirements may be driven by federal and/or state regulations and it is imperative that your product development team fully understands all applicable regulations required testing protocols.

Nectar is dedicated to compliance and rigorous HFE testing during all phases of the product design and development process. Our passion for innovation has resulted in the development of a range of award-winning products spanning industries including medtech, consumer products, high-tech, electronics, industrial, and sustainable technologies.