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Risk assessment for surgical equipment

A medical manufacturer had US-approved surgical equipment, but its current design was not working for some international markets.

Challenge

International markets required the system to be smaller and more compact, but still maintain the necessary functionality. With the new changes, the manufacturer wanted to conduct testing in the US to get FDA approval, which would facilitate approval in international markets.

Approach

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.

Outcome

We evaluated and updated their Risk Assessment (uFMEA), aligning with previously submitted documents, while identifying new risks and user paths for the redesigned equipment.

Human factors training course designed for FDA

The FDA reached out to the Human Factors and Ergonomics Society (HFES) to assemble a team of experts.

Challenge

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.

Approach

Three experts were chosen by HFES to design and deliver the two-day training, including Korey Johnson (Bold Insight), Dr. Anthony Andre, and Michael Wiklund. The team covered topics ranging from the history and origin of HF as a practice to user-centered design principles.

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.

Outcome

The team provided the FDA with the scientific underpinnings of HF – on one hand to amplify instances where requests for additional research are warranted, and on the other hand to provide the scientific context for when that additional research may not be warranted.

Human factors training course designed for medical device team

A global medical device manufacturer wanted to promote internal awareness of and appreciation for best practices in the application of human factors engineering to medical device development.

Challenge

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.

Approach

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.

Outcome

Stakeholders walked away with tangible next steps to ensure their current products under development were receiving adequate human factors attention.

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