Webinar Debrief: Developing HFE Strategies to Meet Global Regulations

By Allison Strochlic and Merrick Kossack 

If you missed our February 15, 2023 webcast, here you can read a summary. This debrief highlights some of the key topics presented during our webinar on developing Human Factors Engineering (HFE) strategies to meet global regulations, presented by Emergo’s Senior Research Directors Allison Strochlic and Merrick Kossack. 

HFE across the globe  

In the U.S. and Europe, the HFE adoption is fairly mature. The U.S. Food and Drug Administration (FDA) has strong requirements for manufacturers to generate evidence of use safety, the key to which is the development of a rigorous use-related risk analysis (URRA) and collection of human factors validation data. Europe has moderate regulatory maturity and a moderate level of HFE enforcement. While the FDA conducts rigorous reviews of the content of HFE submissions, regulatory bodies in Europe are historically more likely to check for conformance to applicable standards, rather than conducting a detailed review of each activity. Notably, however, the amount of attention paid to HFE in Europe is increasing, in particular due to the updates to the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Europe upholds the global standard IEC-62366, which describes an HFE process that emphasizes use-related risk management.  

Compared to the U.S. and Europe, China’s and Japan’s regulatory maturity and HFE enforcement are relatively low  with minimal reviews of HFE submissions. However, the HFE enforcement is increasing. In particular, there is a rapidly increasing requirement for manufacturers to collect local HFE data and conduct HF validation testing in China and Japan. China’s National Medical Products Administration (NMPA) released their first draft of HFE guidance in 2020. The latest draft was released in October 2023 and largely reflects the requirements set forth by the FDA and IEC-62366. Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has published a standard called JST-62366, adapted from IEC-62366, which calls for the application of HFE to medical devices. The current grace period is nearly at a close, and the PMDA will start enforcing JST-62366 on April 1, 2024.  

For an overview of additional regions, you can also see our webinar on understanding international HFE regulations for medical devices. 

The common goal of global HFE requirements   

All regulators are looking for the same fundamental HFE activities to be performed during development. They expect you to define intended users and use environments, develop a comprehensive use-related risk assessment (URRA), and validate that the user interface (UI) design and risk mitigations are effective. As a result of this common goal, many of the core requirements overlap across the regulators. 

Developing a strategy  

When developing a global HFE strategy, you should determine where and when you want to market your product. If you are seeking to enter multiple markets or might expand in the future, it is optimal to plan for broader regulatory expectations early on. This might result in an increase in the near-term HFE effort, but it will reduce the need for repeat work later and is ultimately more resource-effective. 

Cornerstone activities from a global perspective   

When executing your strategy, there are some key tasks.

Research intended use. Researching the intended use of your device includes learning about the users, use environments, and contexts of use. This step is vital when developing a global strategy and it is important to conduct user research in most, if not all, of your target markets.  

Early research might reveal that users across your markets have different characteristics. Cultural differences can affect device use when interpretations of color, symbols, and language differ. Device experience, as well as healthcare professionals' training and responsibilities, can also vary across regions. 

Use environments might differ in characteristics such as lighting, layout, or the presence of certain equipment. It is imperative to understand these similarities and differences: understanding the use context is crucial to the development of a product that is right for its users and use environment.  

Perform formative evaluations. Formative evaluations are essential when conducting global HFE activities. You cannot determine how regional differences will affect device use until the device is in your target users’ hands. Formative evaluations are also useful for determining the scope of your HF validation test. Some non-US markets will accept data collected in other regions. Formative test data can be used to justify that data collected in one region applies to another.  

Conduct HF validation/summative test. HF validation requirements differ across regions. The FDA and NMPA require HF validation test participants to be U.S. and China residents, respectively. For other submissions, the ability to submit non-local data will depend on learnings from user research and formative evaluations. If intending to leverage data from other markets, a strong justification is needed for equivalency and the data to support it.  

The EU, UK, and Japan do not have specific requirements for the number of participants per distinct user group. If there are multiple user groups and it is a lower-risk device, 8 – 10 participants per distinct user group might be considered. The FDA and NMPA expect at least 15 participants per user group. One thing that all regulators agree on is that company employees cannot be test participants within the HF validation. The NMPA further states that employees should not conduct the test or contribute to data analysis. For China, manufacturers are therefore required to engage a third party to conduct HF validation testing. 

Research helps skip surprises and finish strong 

Conducting HF activities for global markets can come with surprises, and it can be expensive and time-consuming to learn new information during HF validation. We always recommend starting HFE activities early and applying them throughout the development process, but it is even more important when a product is intended to be brought to multiple markets. Even small-scale HFE work in multiple regions is better than no research. And of course, to make the most of an HFE investment, be sure to document HFE work clearly and completely.  

Contact our global team to learn more about conducting HFE work around the globe. Or, sign up for a complimentary account with OPUS, our team’s software platform that provides HFE training, tools and templates.  

Allison Strochlic and Merrick Kossack are Senior Research Directors at Emergo by UL.