NMPA issued the notice “Soliciting Feedback of Guideline on Medical Device Human Factors Design for the Second Time” on October 11, 2023, after the first round released in May 2020. The feedback needs to be submitted by October 30, 2023.
This proposed guideline applies to the human factors design and usability engineering of Class II and III medical devices but does not apply to in vitro diagnostic reagents. It refers to international regulations such as FDA’s “Applying Human Factors and Usability Engineering to Medical Devices” and “List of Highest Priority Devices for Human Factors Review”, etc.
The draft document introduces the Main Concepts (Human Factors Design and Usability; Users, usage scenarios and user interfaces; medical device usage and user operation), Basic Principles (human factors design positioning; use risk orientation; full life cycle management), and the design process. It also specifies the research materials for human factors design.
Design Validation and Confirmation
In the Design Validation and Confirmation section, it discusses the two phases: formative evaluation (human factors design validation) and summative evaluation (human factors design confirmation), and the importance of documenting and reporting:
Formative Evaluation: Enhancing Design
Formative evaluation, also known as human factors design validation, primarily focuses on the early stages of the design process. It encompasses activities like expert reviews, cognitive walkthroughs, and usability testing. The core objective is to detect and rectify potential usage errors and difficulties, thus refining the user interface. Typically, 5 to 8 users per group participate, with multiple iterations to reveal and address common usage issues. Formative evaluation necessitates a well-structured test plan to guide the process. This plan considers aspects like the purpose, participant selection, methods, tasks, data collection, and result analysis. Identified issues and difficulties are meticulously documented and incorporated into risk control measures to improve the user interface design.
Summative Evaluation: Confirming Effectiveness
Summative evaluation, or human factors design confirmation, comes into play after the design is solidified. Its primary goal is to ascertain that the user interface meets user requirements while maintaining acceptable usage risks. Testing can involve either simulation or real-world scenarios, with participant numbers determined statistically. The process encompasses the development of detailed test plans, participant recruitment, training, data collection, analysis, and comprehensive reporting. All of these aspects are meticulously documented to provide a clear picture of the safety and effectiveness of the medical device.
The Significance of Documentation
At every phase of the evaluation process, comprehensive documentation plays a pivotal role. It ensures transparency and serves as a valuable resource for regulatory bodies. For equivalence evaluation, a detailed report must be prepared, highlighting the purpose, criteria for comparison, supporting evidence, and the qualifications of the evaluators.
Technical Considerations for Imported Devices
In the technical considerations, the guideline describes the following:
- Clinical trials
- Imported medical devices
- Ready-made user interface
- Combined use
- Human factors design changes
For imported medical devices, it’s crucial to consider differences in user interfaces and regulatory requirements. Existing designs may not guarantee the safety and efficacy of these devices in the Chinese context. High-risk devices require an analysis of human factors design disparities between China and other regions. If deemed acceptable, a summary evaluation report, a report on post-market usage issues for similar devices, and an analysis of design differences should be submitted. If disparities pose unacceptable risks, further design validation specific to China is necessary. Medium and low-risk devices need to submit an error assessment report and a summary evaluation report for market entry.
The document also attaches the following as annexes:
- High risk medical device product catalog
- Common methods of human factors design
- Basic elements of human factors design
For an English copy of the “Draft Guideline on Medical Device Human Factors Design”, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.