Case study
Supporting HFE documentation and validation for aesthetics device launch
Challenge
A medical device manufacturer developing an aesthetics system needed embedded human factors engineering (HFE) support to prepare regulatory documentation and conduct a validation study to demonstrate safe and effective use.
Solution
We embedded an HF engineer within the product development team to lead the creation of all necessary HFE documentation aligned with FDA and international regulatory guidance. We developed and executed a documentation plan and conducted a summative validation study that included training and test sessions with healthcare providers.
Impact
Our work ensured the manufacturer had the evidence and documentation needed to move forward confidently with regulatory submission.
Bold Outcomes
- Delivered complete HFE documentation set: usability plan, Known Problems Use Analysis, HF Validation protocol, and initial sections of HFE report
- Conducted an in-person HF validation study with representative HCPs
- Provided submission-ready HFE report to support FDA submission
Result
The manufacturer was able to meet regulatory expectations and prepare for FDA submission with confidence in the usability and safety of the device.