This chapter presents an approach to pediatric medical device innovation in the United States and highlights the steps required to go from a great idea to a tangible solution that directly impacts pediatric patients: conceptualization, prototyping, preclinical and clinical testing, regulatory approval, and implementation. We explore the modern Biodesign approach to needs finding and pediatric medical device conceptualization with a focus on the unique challenges of designing such devices. We also discuss the complexities and ethical concerns involved in preclinical and clinical testing. We then examine the regulatory landscape of pediatric medical devices. Finally, we discuss how these devices can be implemented in clinical practice and the importance of fostering public-private partnerships to drive ongoing pediatric healthcare innovation. By the end of the chapter, innovators should have a comprehensive understanding of how to take an idea from conceptualization to clinical use.