Google search leads to revolutionary product
Urologist from Italy partners with Holland-based Encoris to develop portable trainer for removing kidney stones.
A simple Google search could be responsible for bringing the development of a revolutionary medical training device to West Michigan.
About two years ago, Giorgio Bozzini, head of the Department of Urology at Humanitas Mater Domini in Milan, Italy, and a world-renowned urologist, began developing the PCNL Boz Kidney Trainer, a portable training product that provides realistic hands-on surgical experience in percutaneous nephrolithotomy (PCNL) or removing kidney stones. As development of a prototype wrapped up, Bozzini partnered with scientific university Politecnico di Milano to find a mass manufacturer for the product and, after a quick search, came up with Encoris — a medical model maker headquartered in Holland.
Though Encoris mainly produced orthopedic models, the “breadth of quality” found in its products impressed Bozzini, and in spring 2015, he made contact. After some back and forth, the two sides reached an agreement, making Encoris the exclusive worldwide manufacturer and distributor of the PCNL Boz Kidney Trainer. With the agreement, Encoris waded into a new market, a move that now has the company forecasting sales of about $1.4 million with a growth rate of about 35 percent each year.
“This really opens the door to general surgery and that whole field of medicine for us,” Encoris Vice President Jim TenBrink said. “Certainly, this is a testament to our ability to create very dynamic and realistic models and a testament that we can develop trainers outside of our orthopedic world. Our medical knowledge can go into other markets for developing trainers.”
Following their meeting with Bozzini, the team at Encoris made a few small tweaks to the product to ready it for mass manufacturing. The trainer is made up of two parts — a plastic box housing component and the simulated kidney insert, which can be reused. The first prototype was made from a water-based material that began shrinking within 24 hours. Additionally, the kidney insert initially was made from a tube and real pig kidneys, a biohazard issue that would have made shipping impossible under FDA regulations.
So, Encoris worked to create a lifelike insert featuring skin and subcutaneous tissue layers to simulate the body structure around a patient’s urinary tract.
“We’re trying to replicate the human body with materials that closely resemble — but not quite match — and can withstand all the variables of environmental temperatures, abuse of shipping, etcetera,” TenBrink said. “(The insert) is basically a gelatin compound and latex, and it feels like you’re literally squeezing someone’s love handle.”
Weighing about seven pounds and measuring 8 by 8.5 inches across and 6.7 inches tall, the trainer is portable, allowing for off-site surgical training. The structure of the inserts allow for different orientations of the kidney and a variety of situational conditions, including stone shapes and sizes.
The box housing retails for about $850, TenBrink said, and the kidney insert is about $600. The insert can be used about 50 to 100 times before needing to be replaced, he added.
“The unique thing about this trainer is the fact that it’s very lifelike,” TenBrink said. “There’s a number of devices out there, but the closest to this is a clear type of body part, which doesn’t provide a true sense of what’s going on because everything’s open and there’s no challenge to it.
“With this, there’s a ureter, so you can put an endoscope up through the kidney to search for stones, so everything is pretty much like going under fluoroscopy and it gives the trainee a real sense of how to provide PCNL.”
The trainer was approved by the EAU Section of Urolithiasis Masterclass in Milan, the European Section for UroTechnology and other international medical device companies. Here in West Michigan, the trainer was tested by the radiology department at Holland Hospital, where testers said the trainer provided a “realistic approximation” of the location of kidney stones.
“What’s out there today in the market are very static trainers that are ‘one-size-fits-all,’” TenBrink said. “And at Encoris, that isn’t our business model. We try to customize products that open the doors to more lifelike training, and that is exactly what this does.”