Comprehensive Guide to Human Factors Engineering and Usability Testing for Medical Devices
1) Purpose
The purpose of this SOP is to define the process for integrating human factors engineering (HFE) and conducting usability testing in the development of medical devices. These practices ensure that devices are safe, effective, and user-friendly in their intended environments.
2) Scope
This SOP applies to all medical devices during the design, development, and post-market phases. It is relevant to product development, quality assurance, risk management, and regulatory affairs teams.
3) Responsibilities
– Human Factors Engineering Team: Oversees the integration of usability principles into device design and manages usability testing.
– Product Development Team: Incorporates feedback from usability testing into design improvements.
– Quality Assurance (QA): Ensures usability testing processes align with regulatory requirements.
– Risk Management Team: Identifies and mitigates risks associated with user interactions.
– Regulatory Affairs: Ensures compliance with applicable human factors and usability standards.
– Document Control Team: Maintains records of HFE activities and usability testing results.
4) Procedure
4.1 Planning Human Factors Activities
4.1.1 Defining Objectives
– Establish objectives for HFE activities, such as:
– Identifying user needs and usage environments.
– Preventing use-related errors.
–
4.1.2 Developing an HFE Plan
– Create an HFE plan outlining:
– Scope and objectives of usability testing.
– Target user groups (e.g., healthcare professionals, patients).
– Testing methods and acceptance criteria.
– Key milestones and timelines.
4.2 Conducting Usability Research
4.2.1 Identifying User Needs
– Collect data through:
– User interviews and surveys.
– Observational studies in clinical or home environments.
– Feedback from post-market surveillance and customer support.
4.2.2 Analyzing Use Scenarios
– Document use scenarios to understand:
– Typical tasks performed by users.
– Potential challenges or barriers to effective use.
– Environmental factors influencing device operation.
4.2.3 Developing User Profiles
– Create detailed user profiles, including:
– Demographics (e.g., age, experience level).
– Physical and cognitive abilities.
– Context of use (e.g., hospital, home, field).
4.3 Designing for Usability
4.3.1 Applying Human Factors Principles
– Incorporate HFE principles into the design process, such as:
– Clear labeling and instructions.
– Ergonomic design for physical interactions.
– Intuitive user interfaces for software-based devices.
4.3.2 Prototyping and Iteration
– Develop prototypes for usability testing, ranging from low-fidelity models to high-fidelity mockups.
– Refine designs iteratively based on feedback from usability testing.
4.4 Conducting Usability Testing
4.4.1 Preparing for Testing
– Develop test protocols specifying:
– Test objectives and scenarios.
– Metrics for evaluating performance, safety, and satisfaction.
– Test environment setup.
4.4.2 Recruiting Participants
– Select participants representing the target user population.
– Ensure diversity in experience levels and backgrounds.
4.4.3 Executing Tests
– Conduct usability tests using methods such as:
– Observational testing: Participants perform tasks while observed by evaluators.
– Think-aloud protocol: Participants verbalize their thoughts during task performance.
– Simulated use: Testing under conditions mimicking real-world environments.
– Record test sessions and collect qualitative and quantitative data.
4.4.4 Analyzing Results
– Analyze test results to identify:
– Use-related errors and root causes.
– Areas for design improvement.
– Compliance with usability standards.
4.5 Documenting and Reporting
4.5.1 Usability Test Reports
– Prepare detailed test reports including:
– Test objectives, methods, and participant demographics.
– Observations and key findings.
– Recommendations for design improvements.
4.5.2 Updating Design Documentation
– Incorporate usability testing findings into:
– Design specifications and outputs.
– Risk management documentation.
– Human factors engineering file.
4.6 Validation and Post-Market Monitoring
4.6.1 Usability Validation
– Validate that the final design meets user needs and usability criteria through:
– Summative usability testing.
– Clinical evaluations for high-risk devices.
– Document validation results in the Usability Validation Report.
4.6.2 Post-Market Feedback
– Monitor user feedback to identify emerging usability issues.
– Update the HFE plan and device design as needed.
5) Abbreviations
– HFE: Human Factors Engineering
– QA: Quality Assurance
– FDA: Food and Drug Administration
– IEC: International Electrotechnical Commission
– SOP: Standard Operating Procedure
6) Documents
– Human Factors Engineering Plan
– Usability Test Protocols
– Usability Test Reports
– Usability Validation Report
– Risk Management Updates
7) Reference
– FDA Guidance on Human Factors and Usability Engineering
– IEC 62366: Usability Engineering for Medical Devices
– ISO 14971: Application of Risk Management to Medical Devices
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements
8) SOP Version
– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]
Annexure
Annexure 1: Usability Test Report Template
| Date | Test Objective | Participant ID | Task Performed | Observations | Recommendations |
|---|---|---|---|---|---|
| DD/MM/YYYY | Evaluate ease of device setup | P-001 | Setting up infusion pump | Struggled with tubing alignment | Redesign tubing guide |
Annexure 2: Usability Validation Report Template
| Date | Validation ID | Objective | Results | Remarks |
|---|---|---|---|---|
| DD/MM/YYYY | UV-001 | Validate user interface for infusion pump | Pass | User satisfaction met criteria |