Aligning Medical Device Design with Human Behavior.
De-risking product developent by embedding continuous user research from concept to product launch.
Led by Sophie Borleffs (Biomedical Engineer with 10+ years in Health Tech R&D). Userproof bridges the gap between deep user insights, technical product engineering, and regulatory usability validation across international clinical and home environments.
How I can help
Services & Capabilities
Please reach out if you would like to explore a collaboration. I am available for strategic advisory consulting (hourly basis), project-based scoping, as well as contracting roles. Below are examples of core services and capabilities I provide:
Contact me to discuss your custom project scopeUX Research Strategy
De-risk your proposition by building a research roadmap in alignment with clinical, commercial, and regulatory timelines.
01Regulatory Compliance
Usability documentation and regulatory submission support for IEC 62366 and FDA.
02Usability Testing
End-to-end support to set up and execute formative and summative usability studies across clinical and home environments.
03Heuristic & Competitive Audits
Conduct heuristic evaluations on your and competitor products to uncover actionable usability gaps.
04User Insights Framework
Build formal frameworks to collect, evaluate, and prioritize user feedback.
05Synthetic User Research & AI-Assisted UX Design: Currently offering reduced-fee pilot engagements for teams interested in pioneering synthetic research workflows and AI assisted UX design.
Selected work
Selected Case Studies
Click any project card to view its executive summary.
Trusted perspective
What Health Tech Leaders & Startups Say
“Sophie has an ability to navigate the ´fuzzy front end´, turning ambiguity into clear plans. Whether managing complex stakeholders, pioneering new tools and methods, or stepping up to lead a cross-functional practice, she takes true ownership.”
Name
Role at Company
“In her role as Principal Investigator, Sophie brought rigor to our clinical studies while actively mentoring junior researchers. She has an ability to maintain strict clinical compliance without losing momentum.”
Name
Role at Company
“Sophie brought structure to how we gather user insights. She showed us how to translate user tasks into testing scenarios, gather objective feedback, and conduct heuristic evaluations to find usability gaps in our product.”
Jens Peter Heli
CTO at Ably Medical (Aleap)
Representative testimonial placeholders pending approved quotations.
Start a conversation
Bring the user into your next decision.
Tell me what you are building, validating, or trying to understand. I’ll respond with a practical next step.