Risk assessment for surgical equipment
We tested the redesigned device with a surgical team trained on the current system.
This included in-person testing in an outpatient clinic, in the surgical team’s environment. We evaluated system setup, tool programming, and use during a simulated surgery.
Human factors training course designed for FDA
The objective was to provide a training course for the Division of Medication Error Prevention and Analysis (DMEPA) from the Center for Drug Evaluation and Research (CDER) that would offer deeper knowledge of and appreciation for the scientific roots of human factors (HF) research and user-centered design.
A series of modules included the science behind HF, such as human perception, cognition, memory, and learning, as well as best practices in root cause analysis and dealing with the biases associated with subjective data.
Human factors training course designed for medical device team
The objective was to better understand the importance of integrating human factors into the earlier stages of their development process. To accomplish this, our team designed a full-day training, split into two modules.
In the first module, our team provided a broad overview of how feedback from end users should be leveraged early and often during product development, and how that feedback should be integrated into use specifications, task analyses, risk analyses, etc. as well as the overall human factors plan.
In the second module, our team worked collaboratively with stakeholders to apply those best practices to their current products in development and talking through how to implement practical solutions.
Stakeholders walked away with tangible next steps to ensure their current products under development were receiving adequate human factors attention.