April 7, 2023
Last week, several Emergo team members attended the 2023 HFES International Symposium on Human Factors and Ergonomics in Health Care in Orlando, Florida. Over four days, we participated in invigorating discussions around many human factors engineering (HFE) topics and experienced an unmatched opportunity to meet and reconnect with colleagues from around the world; a few of us even popped into Universal Studios!
Below, we describe some of our top HFE takeaways from the Symposium.
Scoping and implementing robust HFE programs for global markets
Most product manufacturers have embraced HFE as a valuable investment and are now refining their approaches to deploy HFE more comprehensively within their organizations. As such, manufacturers are eager to ensure that their approaches, often instantiated by standard operating procedures (SOPs), are well-aligned with regulators’ evolving expectations, both locally and globally. When discussing requirements of global markets, notable conversations centered around the United Kingdom and China, due to uncertainty around the regulatory implications of “Brexit” and the recent release of the National Medical Products Administration (NMPA) draft guidance that includes HFE requirements for market access in China. Moreover, medical device and pharmaceutical product manufacturers have moved beyond the expectation that HFE programs simply need to exist, and now manufacturers are working to ensure that those programs are properly nuanced and scaled to the true needs of a product’s use-related risk profile and relevant regulatory expectations.
Keeping up with FDA expectations
Manufacturers’ representatives and consultants alike remain eager to keep their “finger on the pulse” of FDA expectations and learn from recent feedback others have received via protocol reviews and pre-market submissions. Conference attendees paid close attention to conversations on a range of product types and feedback different attendees received from FDA on a wide array of HFE topics, such as observation vs. knowledge-based tasks, pre-clinical vs. pre-commercial HF validation testing, self-selection studies for over-the-counter products, and comparative use studies. A common theme was a desire for increased understanding of and alignment with the FDA’s current expectations on various topics, most notably use-related risk analysis and HF validation testing.
Reassessing the need for HF validation tests
Although HF validation testing has been considered mandatory for medical device and pharmaceutical products, strategies for forgoing an HF validation test received substantial “airtime” during the Symposium. We shared and learned about how to perform user interface and use-related risk comparisons in lieu of HF validation testing and how to write effective justifications, including core and complementary elements that could strengthen the justification. We’re very excited to see how this could be further leveraged to increase efficiencies of HFE activities required for 510(k) and other FDA submissions.
Leveraging post-market surveillance data
While most HFE work is performed during product development, key insights into a product’s use-safety and future innovation opportunities can be extracted from post-market surveillance (PMS) efforts. The interest in combining HFE and PMS processes led to very interesting discussions around the challenges and solutions related to incorporating HFE data into PMS efforts for smaller organizations and large, multinational companies.
Overall, this year’s Symposium was another successful gathering of committed HFE practitioners sharing our myriad experiences and areas of expertise and learning how we can grow as individual HFE experts and together as an industry. We’re already looking forward to reconvening in March 2024 in Chicago!
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