SBIR-STTR Award

Minimally invasive surgical procedures, although highly beneficial to the patients, require a high level of technical skill, for example, ureteroscopic endoscopic surgical procedures involve inserting a rigid cystoscope into the urethra, introducing a guidewire to the ureteral orifice and switching to a flexible ureteroscope while viewing the procedure on a monitor. There is a growing demand for hands-on training programs for these difficult and highest risk procedures. This phase I commercialization project will demonstrate the feasibility of providing a personal computer-based ureteroscopic endoscopic surgical simulator to train military and civilian healthcare professionals. Simbionix Corporation has a proven record of developing pc-based medical simulators, for complicated, highly risky and least-encounter endoscopic simulation procedures. Evidence demonstrating the effectiveness of medical simulators for training is constantly mounting. And the readiness of the medical world to use simulators in training is likewise accruing. Simbionix Corporation, headquartered in Cleveland, benefits from a close collaboration with the prestigious Cleveland Clinic Foundation. This project will bring to the surgical training market a high fidelity simulator, capable of training health professionals to perform numerous procedures such as stone extraction, stone lithotripsy, opening of strictures and complicated procedures with difficult learning curves such as transurethral resection of the prostate. Many leaders in surgical education and surgical professional associations have become convinced that simulation is the future of medical training. The timing for medical simulators to break through into broad use for training as with the airline industry and to be incorporated into the US physicians certification and recertification process is better than ever. A few factors contribute to the likelihood of successful commercialization of the product: the high quality of simulation together with physician's acceptance of using computer-based technology. There is also increasing of public awareness of medical errors. At the same time there is a constant decline of health insurance reimbursement (Medicare leads this trend). That limits the time that is available for training while trying keeping hospitals profitable. At the same time there are more and more minimally invasive surgery procedures being developed and used that in turn need to be taught. The principal market of medical training, including academic hospitals, community based hospitals, large surgical clinics and continuing medical education centers is estimated to be $1 Billion annually. Medical societies are seeking alternatives for certification and credentialing of practicing physicians according to objective standards. TURP by itself is an estimated at $2 Billion annual market with growing demand for training programs. All these conditions seem to create an exceptional opportunity for an ureteroscopic simulator to become an integral part of medical training for health care professionals both in the army and civilian arenas. Having an effective medical training device will make these advanced medical treatments more available to all patients. Simbionix Corp. has a proven record of successfully commercializing training simulators for minimally invasive medical procedures. Its first product for gastrointestinal procedures was already sold to well-over 100 medical and training centers worldwide.

The objective of this Phase II Fast Track project is to deliver a validated commercial PC-based ureteroscopic endoscopic surgical simulation training system for military and civilian health care professionals. This project will transform the existing simulator into the most effective training tool available, capable of training military and civilian health professionals to perform numerous procedures such as stone extraction, stone lithotripsy, cutting strictures and complicated procedures with steep learning curves such as TURP (the standard therapy for men with benign prostatic hyperplasia). Fast track Phase II will pursue advanced development of the endourology simulator; designs will be optimized, fabricated, and integrated into the URO Mentor. The project will be conducted in collaboration with the National Capital Area Medical Simulation Center (NCA Simulation Center), the Cleveland Clinic Foundation (CCF), and Emory University Hospital. A TURP training module will be completed and added onto the URO Mentor, and force feedback sensations will be added to the simulation scenarios. Existing didactic tools will be refined and improved. The NCA Simulation Center will design and conduct, together with Emory, a comprehensive validation study to ensure the simulator meets both army and civilian requirements. Upon completion of Fast Track Phase II a validated medical training simulator, URO Mentor, will be available to the medical marketplace for training on ureteroscopic procedures from basic skills tasks to full procedures

Keywords:
simulator, endourological procedures, validation, medical training, force feedback, turp, prostate