Understanding and applying human factors is essential to ensuring product usability and user satisfaction. More importantly, consideration of human factors during the design and development of medical devices helps to ensure patient safety by minimizing the risks introduced by user error. This course begins with the fundamental principles of human factors and builds on that foundation each week to cover core concepts and demonstrate how human factors fit into the larger context of medical device software and hardware development. Lessons address the integration of human factors and usability into the product development lifecycle, regulatory considerations, including applicable FDA guidance and standards (ANSI/IEC), and human factors methods.

The course is beneficial for professionals who already have a basic understanding of risk management and quality systems, as well as a broad range of technical professionals, including those with no prior medical device experience.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Learning Outcomes

At the conclusion of the course, you should be able to

• Define the role of human factors in the medical device design process
• Understand appropriate human factors methodologies for the development of medical devices
• Identify human factors standards relevant to medical device development.
• Review human factors documentation against the standards and process.
• Discuss human factors engineering requirements.
• Identify usability issues related to product design.

Topics Include

• Applicable Standards/Guidance Documents
• Task/Workflow Analysis
• Formative & Summative Evaluations
• 62366 Checklist

Notes