Human Error Risk Management in Medical Device Design

The topic delves into the critical interplay between human factors, design processes, and patient safety within the realm of healthcare technology. It begins by elucidating the multifaceted nature of human errors, encompassing cognitive, perceptual, and physical aspects, and underscores their potential impact on patient well-being.

The discourse then navigates through the principles of risk management, emphasizing the identification, assessment, and control of potential hazards inherent in medical device design. Regulatory frameworks, such as ISO standards and FDA guidelines, are explored to underscore the imperative nature of adhering to rigorous safety standards.

The content also delves into the integral concept of human-centered design, elucidating its principles and methodologies, including usability testing and feedback incorporation, to optimize medical devices for user capabilities and mitigate the risk of errors. Through case studies, the narrative brings real-world examples to the forefront, showcasing instances of both success and failure in implementing human-centered design principles.

The exploration extends into future trends and challenges, encapsulating the evolving landscape of medical device technologies, regulatory dynamics, and the persistent challenges in fostering a culture of patient safety through effective design strategies. Ultimately, the topic serves as a comprehensive examination of the pivotal role played by human factors and risk management in shaping the landscape of medical device design, with a keen focus on advancing patient-centered care and minimizing potential risks associated with human errors.

Why should you Attend: Participants should engage in this webinar for a transformative and comprehensive understanding of the pivotal intersection between human factors and healthcare technology. The webinar promises to unravel the complexities surrounding human errors in medical device design, shedding light on cognitive, perceptual, and physical aspects that can impact patient safety. By delving into robust risk management principles, participants will gain insights into the identification, assessment, and control of potential hazards, aligning their practices with stringent regulatory standards

Moreover, the session will explore the nuances of human-centered design, offering practical strategies such as usability testing and feedback incorporation to optimize medical devices for user capabilities. Through real-world case studies, attendees will learn from both successes and failures in implementing these principles, ensuring a nuanced perspective on best practices. As the landscape of medical device technologies evolves, participants will also gain a glimpse into emerging trends and challenges, empowering them to navigate the dynamic future of healthcare technology with confidence. This webinar stands as an invaluable opportunity for professionals seeking to enhance their expertise, foster patient-centered care, and stay abreast of cutting-edge developments in medical device design and safety.

Areas Covered in the Session:

• Introduction
• Definition of Human Error in Medical Device Design
• Importance of Risk Management in Healthcare
• Significance of Addressing Human Factors in Medical Device Design
• Human Factors in Medical Device Design
• Overview of Human Factors Engineering
• Definition and Scope
• Relevance to Medical Device Design
• Common Types of Human Errors in Healthcare
• Cognitive Errors
• Perceptual Errors
• Physical Errors
• Impact of Human Factors on Patient Safety
• Case Studies and Examples
• Risk Management in Medical Device Design
• Principles of Risk Management
• Identification of Potential Hazards
• Risk Assessment and Evaluation
• Risk Control and Mitigation
• Monitoring and Continuous Improvement
• Regulatory Requirements for Risk Management in Medical Devices
• International Standards (e.g., ISO 14971)
• FDA Guidelines
• Integration of Risk Management into the Design Process
• Early Identification of Risks
• Iterative Design and Testing
• Usability Testing and Feedback
• Human-Centered Design in Medical Device Development
• Definition and Principles
• Role of Usability Testing
• Usability Studies and Methods
• User Feedback Incorporation
• Designing for User Capabilities and Limitations
• User Personas and Scenarios
• Interface Design Considerations
• Future Trends and Challenges
• Emerging Technologies in Medical Device Design
• Evolving Regulatory Landscape
• Challenges in Implementing Human-Centered Design Principles

• Production and Manufacturing Teams
• Quality Assurance and Control
• Research and Development (R&D)
• Regulatory Affairs
• Training and Human Resources
• Engineering and Maintenance
• Supply Chain and Logistics
• Environmental Health and Safety (EHS)
• Management and Leadership
• Cross-Functional Teams