Co-founded and led product strategy for a digital therapeutics company developing prescription treatments for chronic conditions. As Head of Product, shepherded Stanza—the first FDA-cleared digital behavioral therapy for fibromyalgia—from concept through clinical validation to market launch.
Key Achievements:
• FDA De Novo Clearance: Led product through seven clinical trials (including two RCTs) and secured FDA De Novo clearance (May 2023)—the sixth digital therapeutic in the U.S. to achieve FDA clearance and the first for fibromyalgia. Established new device classification via the most rigorous regulatory pathway
• Fundraising: Raised $20M+ across Seed and Series A rounds from leading digital health investors
• Product Leadership: Directed Product Management, UX/UI Design, User Research, and B2C Marketing teams through complete product lifecycle
• Go-to-Market Expansion: Launched Swing Care (Oct 2022), an integrated telemedicine platform providing holistic fibromyalgia management to complement the digital therapeutic
• Regulatory Innovation: Navigated complex FDA De Novo pathway with no existing predicate device—requiring novel clinical evidence standards and establishing regulatory precedent for future digital therapeutics
• Impact: Delivered evidence-based prescription treatment to thousands of fibromyalgia patients with severely limited therapeutic options
