Bringing innovative digital health products to market—whether AI-enabled Software as a Medical Device (SaMD), immersive extended reality (XR) platforms, or digital therapeutics for mental health—requires navigating an evolving regulatory environment. The U.S. Food and Drug Administration (FDA) continues to refine its oversight of software, AI/ML, and clinical decision support, and companies that align early with clear regulatory pathways gain both speed and confidence.

At Launch and Logic, we help you cut through the complexity. We specialize in regulatory strategy, human-centered evidence generation, and business-aligned product development planning to ensure your innovation reaches patients safely, effectively, and sustainably.

We help you:

• Accelerate market entry: Identify the right pathways and milestones to avoid delays.
• Reduce regulatory risk: Anticipate challenges in AI/ML, SaMD, and digital mental health regulation.
• Maximize adoption and impact: Build transparency, usability, and trust into your product strategy from the start.
  

Founded by Aubrey Shick, a former FDA Senior Digital Health Advisor with over 15 years of experience spanning medical device design, human-robot interaction, and regulatory innovation, Launch and Logic brings deep insight into both the regulator’s perspective and the innovator’s challenges.

Our expertise includes:

• AI/ML-enabled device software “SaMD”, including digital therapeutics (DTx), Digital Diagnostics (Dx), Clinical Decision Support (CDS)
• Regulatory and business strategy integration
• Human factors and usability in healthcare technologies
• Extended reality (XR/VR/AR) medical applications
• FDA engagement and advisory committee preparation
  

Ready to bring your digital health innovation to market with confidence? Contact us today for a free initial consultation or explore our services to learn more.