Innovation and commercialization pathway in gastrointestinal endoscopy: a practical primer from American Society for Gastrointestinal Endoscopy.

Gastrointestinal endoscopy has undergone rapid technological evolution, yet many clinician innovators remain unfamiliar with the pathways required to translate ideas into commercially viable technologies. This practical primer from the ASGE Fostering Innovation Task Force provides an overview of the innovation and commercialization process for endoscopists, including concept development, prototyping, intellectual property strategy, regulatory pathways, startup formation, funding mechanisms, and common pitfalls that hinder successful translation. The article also reviews the roles of technology transfer offices, FDA regulatory frameworks, reimbursement considerations, and emerging issues related to software and artificial intelligence-enabled medical devices. By outlining key strategic, regulatory, and operational considerations, this primer aims to equip clinician innovators with foundational knowledge to navigate the pathway from unmet clinical need to scalable endoscopic technology.