A healthcare company sought HFE support in the development of an HF plan for a drug/device combination product and its accompanying IFU.
Provide documentation and develop HF plan for combination device
Challenge
A healthcare company needed dedicated human factors engineering (HFE) support for the development of a drug/device combination product and its accompanying instructions for use (IFU). We were asked to create and refine HFE documentation, and to provide strategic consulting for human factors (HF) planning in preparation for necessary formative and summative testing.
Approach
We developed an HF plan and associated documentation and provided consulting on the HF development and regulatory approach. This included identification of target users and specified use cases per ANSI/AAMI/ISO 62366-1, identification of use-related risks and proposed strategies for risk mitigation, and development process documents.
Outcome
We provided the following HFE documentation to the client: User Requirements Specification, Use Specification, Use-Related-Risk Analysis, and an HF Plan outlining rationale for development/testing, areas of focus for formative testing, and identification of critical tasks to be validated in future summative testing.