A medical device manufacturer sought HF engineering support to develop HFE deliverables and conduct a validation study for an aesthetics device.
Prepare HFE documentation for aesthetics device system
Challenge
A medical device manufacturer wanted an embedded human factors (HF) engineer to support product development team by defining, creating, and refining human factors engineering (HFE) deliverables for an aesthetics device. Additionally, they needed to conduct a summative validation study to determine whether the device was safe and effective for intended use.
Approach
We created and executed a documentation plan based on FDA and international HF guidance documents to fulfill regulatory agency expectations and to ensure readiness to demonstrate safe and effective use of the device. We then conducted an in-person validation study, including a training session and a test session, with healthcare providers (HCPs).
Outcome
HFE deliverables we provided to the client included a usability plan, a Known Problems Use Analysis, HF Validation Protocol, and initial sections of the HFE report. Once validation testing was finished, we completed and prepared the HFE report for submission to the FDA.