Miyazaki Enterprises
Miya Model™ Leads the Way in Surgical Precision and Patient Safety

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iyazaki Enterprises is enhancing obstetrics and gynecology residency training through rigorous research and technological innovation. This commitment is matched by a focus on those who matter most—patients and their doctors. By placing them at the forefront, the company ensures that every development and groundbreaking study is rooted in improving patient care and outcomes. With this operational ethos, Miyazaki Enterprises conducts research and designs novel training models that enhance learning efficiency and lead to exceptional care delivery.

Central to Miyazaki Enterprises’ innovative edge is the Miya Model™, a practical, impactful and highly validated standardized training model for vaginal surgeries. Patented in the U.S. and China, this model offers a realistic simulation of the female pelvic anatomy, allowing residents to refine their skills in a stress-free environment.

The result? Enhanced surgical precision and heightened patient safety, encapsulated in a cost-effective training solution that equips OB/GYNs with the essential knowledge and experience needed to master the art of vaginal surgery.

Miyazaki Enterprises is not just developing simulation training solutions but also rigorously validating them. A landmark nationwide study on vaginal hysterectomy is already underway–graciously funded by the National Institutes of Health (NIH), specifically, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It compares the performance of residents trained with the Miya Model against those with standard training, promising to provide empirical evidence of the model’s superior training efficacy.

Over the past decade, Miyazaki Enterprises has dedicated substantial resources to developing the Miya Model. Before receiving its first NIH grant, the company undertook rigorous benchtop testing of the model’s key parameters to prove its effectiveness. More than a year of intensive research and development (R&D) went into refining each model component, ensuring that every aspect was optimized. Through these efforts, the company is leading the way in improving medical training and enabling surgeons to practice and upgrade their gynecologic skills in a lifelike, controlled environment.

Evaluating The Impact On Training Effectiveness

Miyazaki Enterprises has made a groundbreaking advancement in the field of gynecological surgery through its first-of-its-kind study on vaginal hysterectomy. As part of this pivotal research, the company modified the vaginal surgery skills index (VSSI) and showed that it could distinguish, in a modified yet quantitative manner, novices from expert surgeons on the Miya Model.

The study assesses the operating room (OR) performance of residents trained on the proprietary Miya Model versus those from standard training programs. Miyazaki Enterprises is one of the first to perform concurrent studies to validate the real-world efficacy of simulation-based training for vaginal surgery, earning it the honor of being the first recipient of the Phase Two B grant from NICHD.

Structured as a multi-site trial (or research program), the study includes residents from seven different institutions, each with fewer than ten vaginal hysterectomies to their name before the study. Participants are divided into two groups–a control group that continues with standard institutional training and an experimental group that receives simulation training using the Miya Model.

The study begins with initial benchmarking to establish the residents’ baseline surgical skills. The experimental group then undergoes training sessions on the Miya Model until they achieve a passing score according to the modified VSSI. The study then compares the first live surgeries of the two groups to validate the Miya Model’s effectiveness in enhancing surgical skills.

“By validating our OR readiness score, we will demonstrate a difference in the skills obtained during training as evidenced in the OR,” says Noah Miyazaki, Vice President of Business Development.

Elevating Training With The Miya Model

In a landscape where OB/GYNs face political, legal and regulatory hurdles, increased skills requirements and a decline in expertise, the Miya Model^™ functions as a lifeline.

This technology platform is designed by physicians for physicians, enhancing training, communication and knowledge sharing. It allows users to refine their skills through repetitive practice ‘before’ operating on live patients. The approach ensures that OB/GYNs can continue to impart knowledge to future generations despite the growing complexities in the field.

Training on the Miya Model is time-efficient and cost-effective compared to traditional cadaver and OR training because it features a realistic pelvic frame with replaceable anatomical cartridges.

Noah calls it a ‘surgical Lego set’ that allows surgeons to perform multiple gynecologic simulations in a controlled, stress-free environment by removing and replacing cartridges and simulating different scenarios. The efficiency of this repeatable, portable platform not only reduces the need for expensive cadaver resources but also saves time by allowing OB/GYNs to enhance their skills before applying them to actual patients.

The Miya Model is designed with lifelike skin, life-size organs, realistic cutting and puncturing tensions, palpable surgical landmarks and a pressurized vascular system that bleeds with the improper surgical technique. It also consists of an inflatable bladder that leaks water if damaged.

Surgeons can cut, sew, dissect, and perform operative procedures on the model. They can clamp, cut and tie pedicles and feel the characteristic pop when passing needles through surgical planes. This design provides immediate positive or negative feedback to the user while helping them develop muscle memory.

Physicians can use the Miya Model for bimanual exams, speculum exams, cervical visualization and pap smears. It enables palpation and identification of key surgical landmarks and supports a range of procedures, including endometrial biopsy, bladder catheterization and operative hysteroscopy. The model also facilitates total vaginal hysterectomy with or without bilateral salpingo-oophorectomy.

OB/GYNs and urologists can practice transobturator sling placements using inside-out and outside-in approaches. Retropubic sling placements can be conducted using top-down and bottom-up techniques, expanding the model’s utility for various pelvic floor procedures.

The Miya Model transcends the boundaries of basic training by enabling full-thickness vaginal wall dissections to the arcus tendinous fascia pelvis, providing a comprehensive training experience for intricate surgical techniques. Furthermore, it facilitates bilateral sacrospinous ligament suspension and diagnostic cystoscopy training.

The model’s versatility ensures that physicians can master various procedures essential for female pelvic medicine, reconstructive surgery and urology. Going the extra mile, Miyazaki Enterprises provides an extensive information portfolio regarding the most common urogynecology procedures in vaginal surgery through the “Miya App” or “Miyazaki App.”

The Miya Model is used in numerous residency programs across the United States and international hysterectomy courses. It is also deployed in R&D by Miyazaki Enterprises’ surgical partners, who use it for physician education. The model allows practitioners to practice new techniques or products on the simulator before launching them in the market or applying them to patients.

Miyazaki Enterprises has been awarded four NIH Small Business Innovation Research (NIH SBIR) grants for its work with the Miya Model. The company has published research demonstrating the model’s effectiveness, particularly for vaginal hysterectomy, which the American College of Obstetricians and Gynecologists (ACOG) recommends as the ‘approach of choice whenever feasible.’

Miyazaki Enterprises’ commitment to advancing training solutions has led it to preserve and enhance the art of vaginal surgery. Bridging the gap between theoretical knowledge and practical experience, the Miya Model provides the foundational understanding of complex procedures that cultivates a new generation of confident, capable surgeons who can rise to the challenges of modern medicine and provide exceptional patient care.

Continuing The Miyazaki Tradition

Innovation and problem-solving are at the heart of Miyazaki Enterprises’ tradition.

Dr. Douglas W. Miyazaki founded the company to improve the industry’s status quo. A renowned Board-Certified OB/GYN, he completed medical school and residency at Wake Forest Baptist Medical Center in Winston Salem, North Carolina. Dr. Miyazaki is also the son of Dr. Fred Miyazaki, the inventor of the Miya Hook and a pioneer of the saline amnioinfusion technique.

During his residency, Dr. Miyazaki performed an impressive 135 vaginal hysterectomies. The residents from Wake Forest frequently visited his private practice to learn and train under him. He observed that many lacked the necessary skills for vaginal surgeries.

Observing this decline in expertise, he put his efforts and time into developing a simulation model to provide surgeons with a more effective and realistic training tool. This culminated in the creation of the Miya Model. Dr. Miyazaki’s dedication to improving surgical education still upholds the Miyazaki tradition, continuing his father’s legacy.

His team remains dedicated to Miyazaki Enterprises’ guiding principle–Do the right things for the right reasons and live with the results. The company collaborates with educational institutions, professional societies and industry partners. Fostering these relationships will create educational and growth opportunities that will benefit physicians and, ultimately, patients. In addition to conducting studies, it is launching a series of academic courses to provide hands-on skills to physicians.

As Miyazaki Enterprises continues to support patients and physicians, the future of vaginal surgery training is in capable hands. Noah sums it up nicely. “Our goal is to use the Miya Model, our journey and prior research as a baseline to empower OB/GYNs to be their advocates and take charge of their training at their institutions. They can learn the required skills while medical schools reduce the resources needed to train new physicians.”