The Simulated Colonoscopy Objective Performance Evaluation (S.C.O.P.E.) was developed at the Uniformed Services University of the Health Sciences (USU) as a training and assessment tool for physicians who perform colonoscopies. S.C.O.P.E. fills the need for a lower-cost, non-virtual-reality based, valid assessment tool.

Using a colonoscopy model manufactured by Kyoto Kagaku Co, Ltd., and distributed by Limbs and Things, Inc. as a base platform, surgeons at USU created tasks designed to evaluate the skills necessary for diagnostic endoscopy.

In collaboration with the manufacturer and the distributor, a task was developed and validated under a Cooperative Research and Development Agreement (CRADA) and ultimately licensed, resulting in the commercially available Endoscopy Training System (ETS).

Based on a research study demonstrating a 100-percent pass rate of the Fundamentals of Endoscopic Surgery manual skills exam by novice residents, ETS was determined to be a low-technology tool for the objective assessment and training of endoscopic skills. ETS allows surgeons to practice and gain proficiency in flexible endoscopy skills without risk to patients.

As the lead inventor for S.C.O.P.E. and the principal investigator for continued development under the CRADA, Col E. Matthew Ritter, MD, FACS, was key to the successful transfer of the technology due to his knowledge of the endoscopy field, ensuring appropriate licensing terms for the technology as well as the evolution of the endoscopy field.

Joshua Girton, JD, LLM, Associate General Counsel, was involved in the review of the CRADA as well as the licensing terms included in the appendix to the CRADA in order to provide a clear path to licensing. Katherine Lipka, PhD, was the primary contact and negotiator for the agreements that resulted in transfer of the technology to Limbs and Things and Kyoto Kagaku.

Dr. Lipka ensured that the license agreement was moved forward quickly from initial draft to negotiation to execution to address the aggressive timeframe of the commercial partners, allowing for commercial production of ETS. The technology was transferred through the execution of a mutual nondisclosure agreement, a CRADA that included a summary of the partial licensing terms, and an exclusive license agreement.

This transfer of the S.C.O.P.E. technology through a CRADA and an exclusive license agreement demonstrated excellence in technology transfer because the inclusion of the partial license terms in the CRADA allowed for a faster execution of the license agreement with multiple parties, including one based in Japan, thus allowing the licensees to launch the ETS within four months of the license execution. The short timeframe to the launch of the ETS provides surgeons with a better, lower-cost method to advance the skills necessary for endoscopy. The use of the ETS platform in a training curriculum develops the skills required to pass the FES manual skills exam, thereby improving patient safety.

Contact: Col. E. Matthew Ritter, (301) 295-3155, [email protected]