Human Factors Design Consulting

Human Factors Design Consulting (HFDC) specializes in human factors engineering and usability testing for medical device manufacturers. The firm focuses on ensuring medical products meet FDA and IEC 62366-1 regulatory requirements through comprehensive validation and evaluation services.

The company's service portfolio spans the entire product development lifecycle, from early-stage design research and task analysis to summative validation testing required for regulatory submissions. Their approach emphasizes identifying and mitigating use-related risks through methods including ethnographic research, heuristic analysis, formative evaluation, and use-related risk analysis (URRA). They also provide instructional design services for Instructions for Use (IFU) documentation and manage complete Usability Engineering Files (UEF).

HFDC has worked with major medical device and pharmaceutical companies including Medtronic, Masimo, Novo Nordisk, Amgen, and Tandem Diabetes. The firm handles all aspects of usability testing including study design, participant recruitment, facility setup, data collection, and regulatory report preparation.

Organizations should consider HFDC when they need specialized regulatory expertise for medical device human factors validation. The firm's comprehensive service model eliminates the need to coordinate multiple vendors for different validation stages, and their experience with major medical device companies suggests they understand complex regulatory pathways.

HFDC is particularly valuable for companies facing FDA submissions or seeking to address gaps in their existing usability engineering documentation. Their UEF assessment service can identify missing compliance components and provide a roadmap for completion.

HFDC operates exclusively in the medical device and pharmaceutical sectors, focusing on regulatory compliance for FDA submissions. Their entire service portfolio is built around meeting specific healthcare regulatory standards including IEC 62366-1 and FDA guidance for Human Factors Engineering/Usability Engineering (HFE/UE).

The firm specializes in medical device categories requiring rigorous safety validation, serving manufacturers of diagnostic equipment, drug delivery systems, patient monitoring devices, and other regulated medical products. Their client roster spans multiple healthcare verticals including diabetes care, diagnostics, and therapeutic devices.

Mid-sized to enterprise medical device manufacturers and pharmaceutical companies developing products requiring FDA human factors validation. Companies in active product development cycles who need regulatory-compliant usability testing and documentation for 510(k), PMA, or international submissions.