Presentation
MDD19 - Mapping out a global HF validation strategy
DescriptionSince the early 2000s, the U.S. FDA has been regulating Human Factors for medical devices in the United States. In more recent years, four regions have developed their own HF regulatory frameworks and guidance documents: the U.S. (regulated by FDA) complying to FDA’s HF guidance, the EU (regulated under MDR) under the guidance of IEC 62366, the UK (regulated under the new UK MDR, coming winter 2023) under MHRA’s final HF guidance, China (regulated by NMPA) under the NMPA’s HF guidance, and Japan (regulated by PMDA) under the guidance of JIS T62366-1.
HF expectations across all of these regions have evolved in the past few years and are expected to evolve throughout 2024. For example, just recently the FDA released “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers” on September 7, 2023, and China NMPA’s latest draft guidance was just issued as of October 10, 2023. As such, it’s important for human factors professionals to stay up to date on these evolving global HF expectations.
One unique aspect of each regions’ guidance includes testing representative users in their representative use environment, sometimes resulting in the need to perform validation testing using members of that region’s population. This specific guidance often leads HF professionals to ask the following question: how do manufacturers know whether or not they need to perform HF validation tests in other regions? Luckily, manufacturers and consultants alike can build an HF validation strategy that proves, as needed, that their products are safe and effective for use in each country of sale while also avoiding innumerous HF validation tests and increased cost.
In this presentation, we plan to:
• Outline the context of HF validation regulations in the 5 regions listed above
• Describe the user profile, culture, anthropometrics, training expectations, and use environment aspects that should be analyzed and documented to determine whether inter-regional testing is necessary
• Walk through a decision flowchart for how manufacturers can build their international HF validation testing strategy most efficiently while explaining the risks associated with each step in the decision matrix
• Describe one or more case study examples
• Explain how to rationalize why inter-regional testing is not required when appropriate
• Delineate region-specific considerations and requirements for planning for and conducting testing in across regions (for example China’s unique sample size requirement, training requirement considerations, and the recommendation to test in a state-owned test facility).
HF expectations across all of these regions have evolved in the past few years and are expected to evolve throughout 2024. For example, just recently the FDA released “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers” on September 7, 2023, and China NMPA’s latest draft guidance was just issued as of October 10, 2023. As such, it’s important for human factors professionals to stay up to date on these evolving global HF expectations.
One unique aspect of each regions’ guidance includes testing representative users in their representative use environment, sometimes resulting in the need to perform validation testing using members of that region’s population. This specific guidance often leads HF professionals to ask the following question: how do manufacturers know whether or not they need to perform HF validation tests in other regions? Luckily, manufacturers and consultants alike can build an HF validation strategy that proves, as needed, that their products are safe and effective for use in each country of sale while also avoiding innumerous HF validation tests and increased cost.
In this presentation, we plan to:
• Outline the context of HF validation regulations in the 5 regions listed above
• Describe the user profile, culture, anthropometrics, training expectations, and use environment aspects that should be analyzed and documented to determine whether inter-regional testing is necessary
• Walk through a decision flowchart for how manufacturers can build their international HF validation testing strategy most efficiently while explaining the risks associated with each step in the decision matrix
• Describe one or more case study examples
• Explain how to rationalize why inter-regional testing is not required when appropriate
• Delineate region-specific considerations and requirements for planning for and conducting testing in across regions (for example China’s unique sample size requirement, training requirement considerations, and the recommendation to test in a state-owned test facility).
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives