ABOUT US
Launch and Logic, LLC is a consulting practice focused on helping digital health innovators navigate regulatory pathways with clarity, creativity, and confidence. We offer a range of services and partnerships to help you align your regulatory strategy with your product strategy, whether that is engaging with FDA directly or intentionally managing applicable oversight.
FOUNDER
As a former Senior Digital Health Advisor at the FDA’s Digital Health Center of Excellence, I helped shape regulatory policy for AI/ML transparency, medical extended reality, and digital mental health. I also spearheaded the creation of the FDA’s first Digital Health Advisory Committee and led the inaugural 2024 public meeting on generative AI-enabled devices.
My career has spanned both regulatory leadership and industry innovation. Before joining the FDA, I led product design and human-robot interaction at Embodied, Inc., UX strategy at Intel, and human factors engineering at Medtronic. I also serve as a Research Affiliate at the ATLAS Institute at the University of Colorado Boulder, advancing human-centered approaches to digital health.
What I bring:
- Direct FDA experience in digital health regulatory policy and strategy
- Proven expertise in AI/ML, SaMD, CDS, and digital mental health pathways
- Human factors and usability leadership for complex medical technologies
- A collaborative, transparent approach that bridges product innovation and regulatory compliance
At Launch and Logic, I partner with clients to ensure their products are not only regulatory-ready, but also designed for trust, adoption, and long-term success.
