Research Collective

Research Collective is a specialized human factors research firm focused exclusively on medical device design and regulatory compliance. The company operates a dedicated usability lab and provides comprehensive human factors engineering services to help medical device manufacturers create safer, more usable products and navigate FDA regulatory requirements.

The firm's services span the full spectrum of human factors work, including generative and evaluative user research, regulatory strategy and compliance, instructional material development, and physiological research. They offer flexible engagement models including project-based work, facility rental for usability studies, custom training workshops, and participant recruiting services for medical device studies.

Research Collective's team has established significant thought leadership in the field, having published "Humanizing Healthcare: Human Factors for Medical Device Design" through Springer-Nature. The book has received endorsements from notable figures including Don Norman and faculty at Mayo Clinic and Northwestern University. Team members regularly publish in academic journals and present at professional conferences.

Organizations should consider Research Collective when regulatory compliance and patient safety are primary concerns in medical device development. Their specialized focus means they understand the nuances of FDA submissions and can provide defensible research that satisfies regulatory requirements while improving actual device usability.

The combination of research services, laboratory facilities, and training capabilities makes them suitable for companies that need both hands-on project execution and internal capability building. Their academic credentials and published work provide additional assurance of methodological rigor for high-stakes regulatory submissions.

Research Collective operates exclusively in healthcare with 100% focus on medical device human factors engineering. Their work directly addresses medical error reduction and patient safety through evidence-based design of medical products. The firm's expertise spans the specific regulatory requirements of FDA human factors submissions, including IEC 62366 compliance and FDA guidance interpretation.

Their healthcare specialization extends to understanding clinical workflows, recruiting appropriate clinical user populations for studies, and evaluating devices in realistic use contexts. The company's published work and academic contributions demonstrate deep engagement with healthcare-specific human factors challenges including alarm design, medication administration systems, and surgical device usability.

The ideal client is a medical device manufacturer developing products that require formal human factors validation for FDA submission, particularly companies working on Class II or Class III devices where use errors could result in serious harm. Companies benefit most when they need both rigorous research methodology and regulatory expertise, or when building internal human factors capabilities through training programs.