Surgeons typically learn their trade or how to use a new device by peer-to-peer training in the operating room, which can be an expensive endeavor. They also get practical experience working on cadavers and animals. But the cadavers can be more than unpleasant and animal rights groups are increasingly vocal.

What's the alternative? Lifelike models are being increasingly used to train both new surgeons as well as veterans who are learning how to use a new device. And they're nothing like the hard plastic heart model you see on the doctor's desk either.

The Chamberlain Group (Great Barrington, Massachusetts) now produces more than 450 products ranging from an upper GI model that includes a mouth and nose leading to an esophagus, stomach and duodenum for endoscopic exploration to a beating heart.

"There's a big effort being made to use computer graphics, virtual reality and simulations to create an experience akin to what's done in training of pilots," company co-founder Lisa Chamberlain told Medical Device Daily. "They're put into a simulator environment and it's done for surgical and interventional training and some of it is very effective. But for the kinds of interaction that require direct tissue contact between the physician and trainee, that's a much harder sell. So our goal in our work is to provide a reasonably affordable solution that addressees that hands-on tactile experience."

Made of silicone and other polymers, the demand for Chamberlain products is growing. The majority of model buyers are medical device manufacturers who need a mechanism to train surgeons on a new device. But now the products are being used for surgical training too.

"It's gone from a novelty and a way to demonstrate procedures to a much more prevalent form of training," she said. "I'd like to think we've had some effect on the acceptance of these products by virtue of them being realistic enough."

With just a handful of similar companies in the world, Chamberlain and her husband, Eric Chamberlain, started the business a decade ago by chance. The company has continued to grow, seemingly unaffected by the downturned economy.

"There's a lot going on in the medical device industry and we're doing OK," she said. "I'm hearing more about price sensitivity, but we're still up [in sales] over last year."

Both were previously in the visual effects industry for movies and television with credits such as Superman, The World According to Garp, Predator I and II, The Big Chill, Tootsie, Gandhi, Ghostbusters, and The Matrix. A colleague in the silicone business supplied the Chamberlain's names to a device maker who was searching for somebody to build a realistic model.

"We didn't have a background in this field," she said. "After we got over the gross-out factor, it was very interesting. What's funny about our backgrounds is that it has proved to be extremely useful and pertinent. We understood the technologies in frequent use by our clients."

Three of the company's latest models include a sinus trainer, a comprehensive uterine robotic surgery trainer and the next generation of a Robotic System Skills Kit, a modular tool for practicing basic skills in robotic surgery.

The Maxillary Clinical Sinus Trainer was recently designed for Entellus Medical (Maple Grove, Minnesota) to train ENT surgeons on the company's new FinESS Sinus Treatment, a treatment for chronic sinusitis.

Tom Ressemann, CEO of Entellus, said, "Before we had the trainers, we had to fly physicians in for a training session to work on cadavers, which is a logistic and expensive challenge. The trainer now allows Entellus to bring the training to physicians, which is much more convenient for these busy surgeons; and it saves time and money."

The sinus trainer has a life-like patient head and neck with key anatomical landmarks such as the maxillary ostium, uncinate process, ethmoid bulla, nasal septum and turbinates. The structure is derived from actual patient CT data which is then replicated as a 3-D model. The maxillary sinus anatomy differs slightly on each side of the trainer so that the trainee is not limited to just one anatomical situation.

The Uterine Trainer and the Robotic System Skills Kit were developed for Intuitive Surgical (Sunnyvale, California) for training on the company's da Vinci Surgical System.

The Uterine Trainer allows physicians to practice robotic skills used in myomectomy (removal of uterine fibroid tumors), hysterectomy (removal of the uterus) and sacrocolpopexy (correcting vaginal vault prolapse). Following a practice myomectomy using the trainer, the physician can perform a colpotomy (separating the uterus from the vagina) which is a skill performed during a hysterectomy. The remaining vaginal canal may then be affixed to mesh and a sacrocolpopexy performed by attaching the mesh to the available sacral tissue. This trainer has a replaceable uterus which permits unlimited practice.

"Virtually everyone who trains on a da Vinci system first sits down at a Chamberlain model," she said.

The models range in price, depending on the complexity and whether or not it's an off-the-shelf model or one that's been customized.

Cardiovascular models are a big seller for the company. If one needs to train for coronary artery bypass (CABG), a heart and thorax can be purchased.

"But the physician might need to puncture the skin, go between the skin and get to coronary arteries to perform a bypass," she said. "What we would make is the whole chest with replaceable skin, it might have a pre-made opening. But when you get to the heart, we made a slot that accepts the small vessel that can be replaced. It's like a razor blade solution. You buy the razor and then have to buy blades."

The entire CABG training solution can cost $850 to $8,000 for the initial set-up (the razor), depending on whether a customer opts for a standard heart or beating heart in a thorax. Replacement coronaries (the blades) run about $15 a piece; graft vessels run $25 to $30.

"The vast majority of our products are made in response to an inquiry, but once we've created a product, it remains viable in our catalog. We do a lot of off-the-shelf sales," Chamberlain said.

The company, which manufactures everything in house, has developed a rapid prototyping technology with 3-D printing capabilities. Very often there's a rigid component, which is made out of sheet plastic or other materials.

"We can take CT scans and MRI data as 3-D CAD files and go out to a 3-D printer, to make a negative and then a mold," she said. "Hearts are the biggest sellers. But we've made a lot with vein pads to teach IV and catheter insertion too."

With an ever-increasing need for realism, the company is hearing more inquiries from prominent surgical training institutions.

"We're growing as more minimally invasive procedures are learned and people are being trained," she said. "But the inverse is happening too. We got a grant from the John Adams Institute to develop a trainer for open bowel procedures because so much is happening laparoscopically that resident fellows are faced with the 'uh oh' factor when they have to suddenly open the patients up for one reason or another. They are used to being trained on minimally invasive techniques [and they need to know how to surgically open the anatomy when necessary]."

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