415Agency

415Agency is a UX design firm based in San Mateo, California, focused exclusively on healthcare technology and medical device product design. Founded in 2014, the company has completed over 30 projects for MedTech and HealthTech companies worldwide, with experience spanning surgical devices, neuroscience equipment, telehealth platforms, and electronic health records systems.

The firm specializes in user-centered design with emphasis on clinical workflow optimization, human factors engineering, and regulatory compliance documentation. Their approach integrates business analysis, detailed user flow mapping, and software requirements specification preparation that aligns with development teams. The company positions itself as knowledgeable in FDA, HIPAA, and EU MDR regulatory requirements, ensuring UX processes are documented for compliance submissions.

415Agency has received recognition as a top UX company in the medical sector from Clutch and has been featured in design publications including AIGA, Behance, and European Healthcare Design. The firm works across both HealthTech verticals (telemedicine, FemTech, diagnostics) and MedTech applications (surgical devices, regenerative medicine, critical care).

Choose 415Agency when regulatory-compliant UX design is a critical requirement for your healthcare product. The firm is particularly suited for medical device companies navigating FDA clearance or HealthTech startups requiring EU MDR documentation support.

Expect a design process that emphasizes clinical context, user task analysis, and system usability testing. Their documented approach to integrating UX deliverables into compliance documentation can streamline regulatory submissions while maintaining user-centered design principles.

415Agency operates exclusively within healthcare, serving both HealthTech and MedTech sectors. Their HealthTech work encompasses telemedicine, remote health monitoring, FemTech, diagnostics, and mental health platforms. On the MedTech side, they focus on advanced therapy products, connected surgical devices, regenerative medicine, and critical care equipment.

The firm's healthcare specialization extends to regulatory compliance expertise, including FDA human factors engineering requirements, HIPAA privacy considerations in interface design, and EU MDR documentation. They emphasize clinical workflow analysis, care coordination patterns, and use context specific to patient and clinician needs.

Medical device manufacturers developing Class II or Class III devices requiring human factors validation, HealthTech startups building regulated digital health applications, and healthcare organizations implementing connected care platforms where clinical workflow optimization is essential to adoption.