Drugdu.com expert's response:

The usability engineering report for medical devices holds immense significance as it serves as a pivotal element in ensuring product safety, efficacy, compliance, and market competitiveness. The following analysis unfolds across four key dimensions: regulatory requirements, product risk control, user experience optimization, and enhancement of market competitiveness.

I. Regulatory Mandates: The "Passport" to Compliance

International Regulatory Framework

FDA (United States): Mandates that medical device design adheres to the "human-computer interaction safety principle." 21 CFR Part 820 explicitly stipulates the necessity of usability testing to validate design rationality, with non-compliance potentially leading to product recalls or market access hindrances.

EU MDR (European Union): Incorporates "usability engineering" into the General Safety and Performance Requirements (GSPR), requiring manufacturers to furnish documentation on user interface design, risk analysis, and user testing as essential materials for CE certification.

ISO 14971: This international risk management standard explicitly mandates the inclusion of "use errors" in risk assessments, with the usability engineering report serving as a core document to demonstrate the effectiveness of risk control measures.

Domestic Regulatory Trends: NMPA (China)

The "Guiding Principles for Usability Engineering Registration Review of Medical Devices," issued by the NMPA in 2023, mandates that high-risk medical devices (such as implantable devices and active surgical equipment) must submit usability engineering reports for registration; otherwise, registration will be denied.

II.Product Risk Control: From "Design Safety" to "Use Safety"

Identifying Potential Use Errors

Usability engineering uncovers design flaws by simulating real-world usage scenarios (e.g., operating rooms, home care), such as button misactivation, screen glare, and alarm confusion.

Quantifying Risk Priorities

Leveraging the Failure Mode and Effects Analysis (FMEA) tool, use errors are evaluated based on severity (S), occurrence probability (O), and detectability (D) to prioritize design improvements. Research indicates that medical devices optimized through usability engineering can witness a 60%-80% reduction in use-related adverse events.

III. User Experience Optimization: Enhancing Product Acceptance and Loyalty

Meeting Core User Needs

Diverse user groups, including doctors, nurses, and patients, exhibit significant variations in operational habits and cognitive abilities. Usability engineering tailors interface and interaction logic through user research methods such as interviews, questionnaires, and observation.

Shortening the Learning Curve

Iterative testing refines operational workflows, reducing user training costs. For instance, a CT scanner simplified its operation steps from 12 to 5, cutting new user training time from 2 hours to 30 minutes.

IV. Market Competitiveness Enhancement: The "Invisible Weapon" for Differentiation

Building Brand Trust

In a saturated market, demonstrating a commitment to user safety through usability engineering reports significantly enhances weightage in healthcare institution procurement decisions.

Facilitating International Market Access

The European and American markets adopt a "zero-tolerance" stance on medical device usability, with report deficiencies potentially leading to product rejections. For example, a Chinese in vitro diagnostic device lost a USD 300 million order after failing FDA usability review.

V. Implementation Recommendations: How to Efficiently Complete a Usability Engineering Report?

Phased Execution

Concept Phase: Define core requirements through user personas and task analysis.

Design Phase: Develop prototypes for formative evaluation (Formative Evaluation) and iteratively refine designs.

Verification Phase: Conduct summative evaluation (Summative Evaluation) to demonstrate compliance with regulatory requirements.

Leveraging Professional Tools

Utilize tools like UsabilityLab for user behavior data analysis or MORAE software to record operational processes, enabling precise identification of problem areas.

Cross-disciplinary Team Collaboration

 Integrate expertise from ergonomics, psychology, and clinical medicine to ensure the scientific rigor and clinical relevance of the report.