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

Publication Title

Gastrointestinal endoscopy

Authors

• Venkata S Akshintala
• Amitabh Chak
• Yen-I Chen
• Mouen A Khashab
• Winston Kirton
• Benjamin F Merrifield, Providence St Peter Hospital, Olympia, Washington, USA.
• Nayantara Coelho-Prabhu
• Prateek Sharma
• Timothy Worrall
• Drew Schembre

Document Type

Article

Publication Date

6-17-2026

Keywords

washington; olympia

Abstract

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.

Area of Special Interest

Digestive Health

Specialty/Research Institute

Gastroenterology

DOI

10.1016/j.gie.2026.04.005