Presentation
Introduction to Human Factors for Medical Products (Student Workshop)
DescriptionThis workshop will introduce students to the world of healthcare human factors and promote their entry into this exciting and growing field. The workshop will cover the following topics with the goal of enabling students to enter the healthcare HF industry.
• Current opportunities for Human Factors
• Overview of FDA guidance and standards applicable to healthcare HF
• Typical phases of an HF program
• Application to drug delivery devices (combination drug products)
• Application to medical devices
• Risk-based approaches to HF
• Design of devices, instructions and labeling
• Case Studies of how the HF process was applied for a medical product
• Latest trends and future opportunities
• How to prepare for a career in healthcare HF
• Q&A
Course Outline:
• Human Factors Careers in Healthcare Human Factors
• What are devices and combination products?
• What is considered the user interface for a medical product
• Activity 1: Describe the user interface for 1 of 4 different medical devices.
• What is Human Factors Engineering?
• Benefits of Human Factors Engineering
• Example projects and touch points for medical device and combination product human factors engineering
• Human Factors Engineering at FDA (CDRH,CDER/CBER, DMEPA)
• Key Regulations/Standards/Guidance for FDA and CE Mark
• Market Insights / Early-Stage Research (User Interviews, Contextual Inquiry, understanding the users, use environment and context of use)
• Activity 2: Identify the foundation for the use specification for 1 of the 4 medical devices described in Activity 1.
• Use-Related Risk Analyses (Inputs, Known Use Problem Summary, Process)
• Product Design and User Interface Specifications
• Formative Evaluations (Heuristic Evaluations, Cognitive Walk Throughs, Usability Testing)
• Activity 3: Perform a heuristic analysis for a specified medical product.
• Human Factors Validation/Summative Evaluation (Difference between formative and summative, Selection of critical tasks, Types of activities (simulated use. knowledge tasks, user documentation assessment)
• Human Factors Submission (FDA HE/UE Report requirements, Usability Engineering File)
• Design of devices, instructions and labeling (as time allows)
• Case Studies of Human Factors Engineering (AED, combination product)
• Tailoring the Human Factors Engineering Process
• Latest trends and future opportunities
• Preparing for a Career in Healthcare Human Factors
Benefits:
Human Factors in healthcare is unique due to FDA’s influence on the process and requirements for human factors engineering for medical devices and combination products. During the workshop, the instructors will share information and resources to acclimate and prepare students and Human Factors Engineers who are new to medical products for careers in healthcare human factors, a growing and exciting field.
• Current opportunities for Human Factors
• Overview of FDA guidance and standards applicable to healthcare HF
• Typical phases of an HF program
• Application to drug delivery devices (combination drug products)
• Application to medical devices
• Risk-based approaches to HF
• Design of devices, instructions and labeling
• Case Studies of how the HF process was applied for a medical product
• Latest trends and future opportunities
• How to prepare for a career in healthcare HF
• Q&A
Course Outline:
• Human Factors Careers in Healthcare Human Factors
• What are devices and combination products?
• What is considered the user interface for a medical product
• Activity 1: Describe the user interface for 1 of 4 different medical devices.
• What is Human Factors Engineering?
• Benefits of Human Factors Engineering
• Example projects and touch points for medical device and combination product human factors engineering
• Human Factors Engineering at FDA (CDRH,CDER/CBER, DMEPA)
• Key Regulations/Standards/Guidance for FDA and CE Mark
• Market Insights / Early-Stage Research (User Interviews, Contextual Inquiry, understanding the users, use environment and context of use)
• Activity 2: Identify the foundation for the use specification for 1 of the 4 medical devices described in Activity 1.
• Use-Related Risk Analyses (Inputs, Known Use Problem Summary, Process)
• Product Design and User Interface Specifications
• Formative Evaluations (Heuristic Evaluations, Cognitive Walk Throughs, Usability Testing)
• Activity 3: Perform a heuristic analysis for a specified medical product.
• Human Factors Validation/Summative Evaluation (Difference between formative and summative, Selection of critical tasks, Types of activities (simulated use. knowledge tasks, user documentation assessment)
• Human Factors Submission (FDA HE/UE Report requirements, Usability Engineering File)
• Design of devices, instructions and labeling (as time allows)
• Case Studies of Human Factors Engineering (AED, combination product)
• Tailoring the Human Factors Engineering Process
• Latest trends and future opportunities
• Preparing for a Career in Healthcare Human Factors
Benefits:
Human Factors in healthcare is unique due to FDA’s influence on the process and requirements for human factors engineering for medical devices and combination products. During the workshop, the instructors will share information and resources to acclimate and prepare students and Human Factors Engineers who are new to medical products for careers in healthcare human factors, a growing and exciting field.
Authors
Event Type
Workshop
TimeSunday, March 308:00am - 5:00pm EDT
LocationPier 4