Boulder Startup Week 2025

Aubrey Shick is a former Senior Digital Health Advisor and Partnerships Manager at the FDA’s Digital Health Center of Excellence, where she led pivotal initiatives on transparency for AI/ML-enabled medical devices, launched the Digital Health Policy Navigator, and formation of the cross-functional Digital Health Advisory Committee, including its inaugural 2024 public meeting on generative AI-enabled devices. Recognized as a policy and product expert in digital mental health, she contributed to FDA reviews, including devices integrating consumer wearables, from smartwatches to AR/VR headsets, into digital therapeutics, diagnostics, and clinical decision support tools. With more than a decade spanning product strategy, UX, and regulatory policy, Aubrey now serves as Principal at Liquid Amber Consulting, advising digital health companies on aligning regulatory strategy with business goals and product design. She is also a research affiliate at the ATLAS Institute at the University of Colorado Boulder. She holds degrees in Industrial Design and Human–Computer Interaction from Carnegie Mellon University.

Talk to me about: digital health policy, FDA/ regulatory strategy, AI/ML or GenAI-enabled medical devices, AR, VR, MedXR, SaMD, clinical decision support software, DTx, DDx, digital mental health technology and policy, LLMs/ chatbots, agents for MBDDs, AI-transparency, FDA enforcement discretion and general wellness policy, human factors and usability, human-centered design, surgical robotics, healthcare at home, consumer & enterprise, agile user-centered research & design, robotic & wearable hardware, wellness/assistive tech, product deployment & customer engagement, ethnographic research, innovations engineering/IP development, beta-launch planning & support, soft-hardware, field-ready prototyping, flat-pack design.