What: Webinar Human Factors Engineering – Applications in Medical Product Development
When: Thursday, August 24th 9:30 – 10:45 (China time zone - GMT/UTC + 8 hours)
Where: Online, Free of Charge
Language: Delivered in English, parallel interpretation with translated slides
Today, regulators worldwide expect that manufacturers will apply human factors engineering (HFE, which is also called usability engineering) methods and design principles in the normal course of developing a safe and effective medical device. In the medical device industry, documentation demonstrating mitigation of use-risks is required for regulatory approval and the ability to place products on the market. For manufacturers, applying HFE means (1) learning the fundamentals of HFE, (2) developing a thorough understanding of the pertinent regulations, standards, and best practices, (2) establishing HFE procedures, and (3) engaging in-house or external HFE resources to perform the required and beneficial work. UL’s webinar on HFE will help audience members make progress on the first couple of tasks: increasing knowledge or HFE and the related regulations and standards.
Specific topics to be covered include:
• FDA’s HFE guidance (updated on February 3, 2016), the latest IEC standard (IEC 62366-1:2015) on usability engineering
• Conducting user research
• Developing a user interface specification
• Performing a task analysis and use-related hazard analysis
• Designing user interfaces to reduce the chance of potentially harmful use errors
• Conducting formative (i.e., preliminary) and summative (i.e., validation) usability testing
• Preparing HFE documents comprising a complete design history file and supporting a regulatory submission
Additional HFE program implementation topics to be covered include:
• Common HFE implementation models
• Costs and benefits of HFE
UL’s Michael Wiklund and Allison Strochlic will deliver the webinar. Mr. Wiklund has 30+ years of applied HFE experience, has written and edited multiple books about applying HFE to medical devices, and is also a professor at Tufts University. He is one of the primary contributing authors of today's most pertinent standards and guidances on human factors engineering of medical devices: AAMI HE75 and IEC 62366.
Ms. Strochlic has over a decade of HFE experience and serves as a Research Director in UL’s international HFE practice. They are co-authors of the book, Usability Testing of Medical Devices. Their hour-long presentation, followed by answers to submitted questions, should give audience members a broad perspective on how to address the regulators’ HFE expectation – making devices safe and more effective by design.
Our presenters will conclude the webinar by describing how UL helps its clients, which include companies developing medical devices, combination products, medical software, and documents (e.g., instructions for use, training aids) fulfill their obligation to apply HFE methods and principles in the course of developing a medical device.
Who should attend:
- Regulatory Affairs (RA)
- Quality Assurance (QA)
- Product managers
- Product marketing
- International sales