Incorporating HFE activities throughout the product development lifecycle provides assurance that medical products have been designed for the correct intended use(s) and that they meet their design input requirements.

We are thrilled to share some exciting news from one of our partners, Byonyks – their latest medical device, the Byonyks X-1 Automated Peritoneal Dialysis (APD) Cycler, has received 510(k) clearance from the FDA! This achievement marks a significant step forward in expanding access to life-saving dialysis treatment, and we are proud to have played a role in this journey.

This spring, our team had the privilege of attending several inspiring events hosted by leading patient advocacy organizations in the surrounding Philadelphia and Chicago areas.

The energy was infectious at this year's Combination Products Summit hosted by PharmaED Resources Inc., where industry and vendor attendees came together in the Philadelphia Historic District to discuss regulatory guidance insights, risk management considerations, and new product and technology innovations…

Key Information:  

• Why Usability Testing for Children Matters 

• Key Challenges in Usability Testing with Children 

• Current Best Practices for Usability Testing 

• Recruitment Strategies for Testing 

The 2025 International Symposium on Ergonomics and Human Factors in Health Care was marked by a spirit of pushing boundaries. Perhaps due to the rare out-of-US location, various human factors (HF) “traditions” were questioned by presenters and attendees – most notably, requirements and expectations around 1) user groups and sample sizes, 2) platform device testing, and 3) knowledge task methods.