SAGE RESEARCH + DESIGN

SAGE Research + Design is a user experience and human factors consulting firm specializing in medical device compliance and healthcare technology usability. The company provides end-to-end human factors engineering services aligned with FDA guidance and IEC 62366 standards, supporting medical device manufacturers through regulatory submissions including 510(k) and De Novo pathways.

The firm's expertise spans medical device human factors, consumer and B2B product UX, healthcare patient and clinician experience, and human factors training. Their methodology includes formative and summative usability testing, heuristic evaluations, use-related risk analysis, and comprehensive documentation for regulatory compliance. The team has worked with both Fortune 500 companies and healthcare startups across medical devices, IT systems, and healthcare facilities.

Led by Shannon Halgren, PhD, who holds extensive experience in human-computer interaction and previously led usability groups at Apple/Claris and Macromedia, SAGE brings academic rigor to practical product development. The company hosts a Medical Technology UX/HF Meetup and offers both in-person and online human factors training for teams seeking to build internal capabilities.

Choose SAGE Research + Design when regulatory compliance is paramount and you need human factors experts who understand FDA expectations. Their specialized knowledge of medical device standards makes them particularly valuable for organizations navigating 510(k) submissions or seeking to strengthen their human factors documentation.

Expect a research-driven approach that balances regulatory requirements with practical usability improvements. Their training offerings provide added value for organizations wanting to develop internal human factors capabilities while maintaining access to expert guidance for critical regulatory milestones.

SAGE's healthcare practice centers on three core areas: medical device human factors engineering for FDA compliance, healthcare facility experience improvement for patients and clinicians, and consumer/B2B healthcare product UX. They demonstrate deep understanding of healthcare-specific standards including IEC 62366, FDA human factors guidance, and ISO HE74/75. Their work spans medical devices, hospital systems, clinician workflow tools, and patient-facing technologies, with explicit focus on use-related risk analysis and regulatory documentation required in healthcare contexts.

Medical device manufacturers preparing for FDA submissions who need compliant human factors engineering and documentation. Healthcare technology companies developing clinician workflow tools or patient-facing applications who value research-backed design decisions. Organizations that appreciate academic rigor applied to product development and may benefit from human factors training to build internal team expertise.