Evaluating Safety & Usability of a Surgical Containment Device (Under NDA)
Summative testing with surgeons and scrub techs to reduce error risk and improve safety.
We validated a surgical containment device through rigorous summative testing with surgeons and scrub techs, ensuring safe use, reducing error risk, and supporting FDA submission.
Timeline
May 2025 - August 2025
Role
UX Researcher
Summative, FDA-Compliant
Leveraged Skills
UX research·FDA usability testing· moderation
PROJECT OVERVIEW
A medical device company developed a new surgical containment bag that required FDA human factors validation before approval. The study needed to demonstrate that surgeons and scrub techs could use the device safely and consistently in simulated surgical conditions. Because errors such as bag punctures posed serious risks, it was essential to capture both task performance and the factors behind failures.
Preparation
Before testing began, I helped refine study materials and set up the lab environment. I updated the protocol and URRA criteria, ensuring critical tasks like blade positioning and obturator use were clearly defined for evaluation. These refinements aligned the study with FDA standards and provided a framework for identifying user errors and difficulties.
I also configured the lab to simulate surgical conditions. This included rigging cameras with OBS software to capture multiple angles, preparing pig heart and tissue models, and ensuring punctures could be detected reliably. Recruiting logistics were finalized by organizing surgeons across three experience tiers and allowing scrub techs to participate in multiple sessions without training decay.
Refined study documents and URRA criteria for FDA alignment
Set up simulation lab with cameras, tissue models, and puncture detection
Testing
I moderated 30 usability sessions across two phases. The first phase tested baseline performance in non-clinical simulations, while the second validated training retention in a clinical-style environment. Each session followed strict FDA protocols to ensure consistency and reliability.
Guided surgeons and scrub techs through critical tasks under simulated conditions
Captured task success rates, errors, close calls, and post-task interview insights
This process revealed how experience level, training format, and task complexity shaped device use.
Analysis
After testing, I classified outcomes into categories such as critical errors, non-critical errors, close calls, and task difficulties. This made it possible to connect findings directly to FDA reporting.
Clear patterns emerged. Surgeons sometimes inserted the device with blades exposed, increasing puncture risk. Others neglected to return the blade to neutral before removal. Scrub techs struggled with tissue handling when training was insufficiently hands-on. In several cases, participants failed to recall procedural steps accurately from training materials.
Blade exposure and improper tool sequencing increased risk of punctures
Training recall gaps led to procedural inconsistencies
Impact
The findings directly shaped revisions to training and documentation. Training emphasized blade positioning, tool sequencing, and hands-on practice. Updated IFUs and videos reinforced these requirements. These changes reduced error risk and improved consistency across sessions.
Reduced puncture risk and improved safe handling
Strengthened FDA submission and client confidence
Reflection
This project reinforced the value of aligning usability research with regulatory requirements while still reflecting real clinical practice. I learned how to design and moderate studies that balance rigor with realistic surgical workflows. Most importantly, I gained experience turning observations into actionable training mitigations that improved both safety and usability.
