usability research

Core Human Factors is a human factors and usability engineering consulting firm for medical devices and combination products. It provides usability research, instructions for use (IFU) development, IRB services, and participant recruiting, supporting regulatory submissions such as 510(k), De Novo, PMA, NDA, ANDA, and BLA. Offices are located in Pennsylvania, California, Texas, and Israel.

comparative analysisEthnographic Researchexpert human factors consultingformative usability testinggap analysishuman factors validation testingIFU developmentinternational usability researchIRB Serviceslabeling comprehension studiesparticipant recruitingpost-market evaluationprototype testingself-selection studiessummative testingtask and use-related risk analysisuser analysis and use specification development

Espiritu Studio is a human-centered product design and engineering studio that turns complex ideas into launch-ready products for healthcare, government, and high-impact outdoor ventures. It is an ISO 13485 certified design + engineering consultancy, partnering with founders, product leaders, and public sector innovators from concept through manufacturing.

Design for Assemblydesign for manufacturingElectrical Engineering (Embedded Systems)Ethnographic ResearchFinite Element Analysis (FEA)industrial designmanufacturing supportMaterials Analysis and SelectionMechanical Engineeringrapid prototypingSolid and Surface CAD ModelingSystems IntegrationTool Ready 3D CAD CreationVendor Identification and Selection

Garofalo UX is a San Diego-based digital experience consulting practice founded in 2016 that helps organizations solve complex digital challenges through human-centered strategy, usability research, and product architecture. It works upstream of delivery, providing strategic UX advisory rather than production design, partnering with startups, scaling organizations, and global teams.

AI experience strategydesign thinking workshopsempathy mappingfractional UX leadershipjourney mappingproduct architectureUX auditsUX Strategy