ANSI/AAMI HE75:2009 (R2018) – Human Factors Engineering: Design of Medical Devices Training by Tonex
This course provides an in-depth exploration of ANSI/AAMI HE75:2009 (R2018), focusing on applying human factors engineering principles to the design of medical devices. Participants will learn to optimize usability, safety, and effectiveness while meeting regulatory and industry requirements.
Learning Objectives
By the end of this course, participants will be able to:
- Understand and apply the principles of ANSI/AAMI HE75:2009 (R2018) in medical device design.
- Identify and address user needs, tasks, and environments in device development.
- Design intuitive and safe user interfaces for medical devices.
- Conduct effective usability testing and incorporate feedback into design.
- Mitigate use-related risks and ensure device safety and efficacy.
- Document human factors activities to meet regulatory and industry requirements.
- Drive innovation in medical device design through user-centered approaches.
Audience
This course is designed for:
- Medical Device Designers and Engineers: Professionals creating user-friendly medical devices.
- Human Factors Specialists: Experts focusing on usability and user experience in healthcare.
- Regulatory Affairs Professionals: Individuals preparing human factors documentation for submissions.
- Quality Assurance Teams: Ensuring devices meet usability and safety standards.
- Healthcare IT Developers: Designing user-centered interfaces for medical applications.
- Product Managers: Leaders overseeing the development of user-focused medical devices.
Course Modules:
Day 1: Foundations of Human Factors Engineering
Module 1: Introduction to ANSI/AAMI HE75:2009 (R2018)
- Overview and objectives of the standard
- Importance of human factors in medical device design
- Key concepts: usability, user interface, and safety-critical design
Module 2: Understanding User Needs and Context
- Identifying users and use environments
- Methods for gathering and analyzing user requirements
- Understanding cognitive, physical, and organizational factors affecting usability
Module 3: Principles of Human Factors Engineering
- Designing for usability and minimizing user error
- Applying anthropometric and ergonomic principles
- Accessibility considerations for diverse user populations
Module 4: Human Factors in Risk Management
- Integrating human factors into ISO 14971 risk management processes
- Identifying and mitigating use-related hazards
- Case Study: Analyzing use errors in a medical device
Day 1 Workshop:
Participants will evaluate a sample medical device design, identifying potential usability issues and proposing user-centered improvements.
Day 2: Applying Human Factors in Medical Device Design
Module 5: User Interface Design
- Best practices for designing intuitive user interfaces
- Visual, auditory, and tactile interface elements
- Designing for consistency, clarity, and feedback
Module 6: Usability Testing and Validation
- Planning and conducting formative and summative usability tests
- Analyzing usability test results to inform design decisions
- Regulatory expectations for usability validation
Module 7: Documentation and Compliance
- Creating human factors design and test documentation
- Aligning with FDA and international regulatory requirements
- Preparing for regulatory reviews and audits
Module 8: Workshop and Certification
- Simulation Exercise: Redesign the user interface of a medical device based on human factors principles and usability test feedback.
- Feedback and debrief on workshop outcomes.
- Certificate of Completion for the ANSI/AAMI HE75:2009 (R2018) course.