Development and Validation of the Miya Model, A Simulator Designed to Train Vaginal Surgery Techniques

Period of Performance: 09/01/2017 - 08/31/2018

$325K

Phase 2 SBIR

Recipient Firm

Miyazaki Enterprises, LLC
Winston-salem, NC 27104
Principal Investigator
Principal Investigator
Principal Investigator
Principal Investigator
Principal Investigator
Principal Investigator
Principal Investigator

Abstract

Miya Model? Simulator: Phase II Abstract OB/GYN Residents must develop numerous skills including pelvic exams, child birth, open surgery, laparoscopic surgery, and vaginal surgery. Studies demonstrate that OB/GYN Residents lack training in vaginal surgical techniques, including Vaginal Hysterectomy (VH). Vaginal Hysterectomy is the desired technique recommended by The American College of Obstetricians and Gynecologists (ACOG) because it is associated with less morbidity, quicker recovery and lower costs than abdominal hysterectomy. Furthermore, Residents do not receive adequate training in vaginal surgery techniques used to treat incontinence, urinary or fecal, or pelvic organ prolapse. The Miya Model? is a complete female pelvic anatomy model designed to simulate real surgical experiences using lifelike skin and life-sized organs, realistic cutting and puncturing tensions, palpable surgical landmarks, a pressurized vascular system that bleeds when inadequate technique is used, and an inflatable bladder that can leak water if damaged. The model is modular in design and all of the parts are easily replaceable when used in a simulated surgery. The anatomical correctness of the model can be used to train a broad range of health professionals on general procedures like bimanual exam, speculum exam and pap smear, as well as advanced gynecologic vaginal surgeries. There is no commercially available simulator that can train vaginal surgical skills and basic gynecological procedures to a breadth of health professionals other than the Miya Model?. The successfully completed specific aims of the Phase I SBIR showed significant progress. Phase I work developed a curriculum for doing VH and created a production design making the Miya Model? and its replacement cartridges more affordable while modifying the design based on surgeon feedback. In Phase I the Miya Model? demonstrated Construct Validity in that performance differences of novices and experts performing a VH on the model were measurable. Construct Validity is a crucial step in simulator's acceptance as a training device. Phase II will encompass seven Specific Aims with the goal of preparing the Miya Model? and its associated curriculum and scoring metrics for wide spread adoption in OB/GYN training. To reach this goal, the objectives of Phase II are to finalize the production design and tooling of the model and replacement cartridges for mass production so that it is affordable for many training programs. The Curriculum for VH developed in Phase I, along with a curriculum for performing a Transobturator sling procedure on the Miya Model? will be converted to tablet ?Apps.? Finally, a scoring system based on objective metrics that are easy to measure will be developed and validated. When complete, the Miya Model? will be used in OB/GYN residency programs to train vaginal surgery techniques and objectively assess surgical competency without any risk or harm to patients. It will also be used in numerous and diverse residency, nursing and allied health educational programs for basic gynecology training. It will also be used by hospitals for credentialing and medical device companies for product development and training.