Mapping Out a Global Human Factors Validation Strategy

By Layne Hartman and Julee Henry  

Historically, the U.S. has been the leader in medical product human factors (HF) engineering maturity with stringent regulatory enforcement, followed by the European Union (EU) with less stringent regulatory enforcement, while most other global regions have had little or no HF guidance or enforcement. However, in the past few years, the global regulatory landscape has continually evolved as other countries including China, Japan and the U.K. have introduced and enforced their own guidance. As a result, manufacturers seeking to market medical products globally must develop a global HF plan to meet these current and evolving requirements. In this article, we explore common questions when forming a global HF validation testing strategy, including one of the most pressing questions: In which countries should HF validation testing be conducted?  

Global regulatory expectations for HF validation testing 

When developing an HFE plan to bring a product to multiple markets, manufacturers must have a baseline understanding of HF validation testing requirements in different regions to optimize a testing plan. Below, we summarize the key requirements for different regions.  

• U.S.: The Food and Drug Administration’s (FDA) final HF guidance calls for testing to be executed in the U.S. with U.S. residents, and they are unlikely to accept HF validation data collected outside of the country.  

• EU/U.K./Japan: These regions will likely accept HF validation data collected outside the country (including data collected from U.S.-based tests) if manufacturers can justify market equivalency (i.e., sufficient similarity between a product’s intended use, users and use environments).  

• China: The National Medical Products Administration (NMPA) might accept HF validation data collected outside the country, depending on factors such as use-risk classification and product novelty. However, manufacturers should also plan to justify use, user, use environment and risk equivalency and/or perform a comparative analysis to demonstrate equivalency with a device on the market if applicable.  

Tips for developing a global HFE validation strategy 

Just because one region, such as the EU, can accept HF validation testing data from another, such as the U.S., does not mean they will accept it without sufficient justification that the user groups and use environment are sufficiently similar. When identifying potential HF validation testing strategies, there are a few HFE activities and data points to consider:  

• Develop and compare region-specific user profiles, use environment descriptions, expected task lists and training plans to identify any regional differences in user groups and device use. In parallel, conduct an analysis of known use problems and a use-related risk analysis (URRA). Assess if any regional differences affect device use and use-related risk. 

• If there are no region-specific differences impacting device use and use-related risk, plan to conduct HF validation testing in the country with the most stringent requirements and submit that data to other regions along with a justification for why the data still applies across those regions, leveraging the aforementioned documentation.  

• If regional differences do impact device use and risk,  expect to conduct testing in all regions for which you cannot justify equivalent use and risk. Manufacturers with scheduling and budgeting constraints might find first seeking approval in the EU to be most cost effective due to less stringent HF requirements (e.g., user group and sample size flexibility). 

While this process works well for most regions and most devices, China has a few other HFE expectations depending on device novelty:  

• China expects supplemental HF validation data focused on any identified HF differences using Chinese, local participants if the device is considered “mature” (i.e., safety and efficacy have been fully confirmed in China’s medical practice)  

• China expects full HF validation testing involving Chinese, local participants unless manufacturers can justify using HF validation collected outside the country if the device is considered “new” (i.e., there is no predecessor and/or safety and efficacy have not been fully confirmed in China)  

Looking ahead to future HFE-related regulatory requirements 

In the coming years, global regulatory expectations will continue to evolve and likely increase as regions develop unique guidance documents and as HF expertise within regional regulatory bodies expands. Notable updates we expect to see within the next year include:   

• China: NMPA released its finalized HF guidance in April 2024 which goes into effect October 2024. Reach out to us for considerations for usability testing in China and to learn more about our partnership with the Shanghai Center for Medical Testing and Inspection (CMTC).  

• Japan: As of April 1, 2024, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) requires conformance to JIS T62366-1. Local HFE data supplementing any HFE data collected elsewhere could be expected in the future if Japan aligns HFE data collection requirements with their clinical trials requirements (i.e., requiring locally collected clinical trial data).  

• U.K.: The new U.K. MDR has extended acceptance of Europe’s CE marking certificate from a Notified Body. Compliance with U.K. MDR’s regulations will begin in summer 2025.   

Our team stays on the forefront of the ever-evolving global HFE regulatory landscape, and we stand ready to strategize and execute HFE activities to efficiently meet global regulatory requirements. Contact our team to learn more about developing an HF validation strategy. Or sign up for a complimentary account with OPUS, our team’s software platform that provides HFE training, tools, and templates.  

Layne Hartman is a Senior Human Factors Specialist and Julee Henry is a Lead Human Factors Specialist at Emergo by UL.