Turning bold ideas into safe, effective medical devices for children requires not just creativity, but clarity on the complex journey from concept to clinical use. This session brings together leaders in pediatric innovation and regulatory science to explore what it takes to move from idea to implementation. Dr. Sharief Taraman will share insights from real-world pediatric innovation projects — how to identify unmet needs, develop prototypes, and navigate collaboration. Dr. Nawar Shara will demystify FDA pathways for pediatric medical device approval, offering practical guidance for innovators working to translate technology into better care for children.