3-D Printing Breaks Through Confines of Traditional Med-Tech Manufacturing

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Medical Device Daily

July 15, 2014

Imagine a world in which people in need of an organ transplant could jump the wait list and have a new lung or kidney 3-D printed in a matter of days. It might sound like a science fiction plot, but 3-D printing has already saved lives and the world has only seen the tip of this technological iceberg. This week, in a three-part series, Medical Device Daily (MDD) will explore the potential of this seemingly futuristic technology, the challenges it presents, and where 3-D printing is likely to have the greatest impact in healthcare.

In the medical arena, 3-D printing began making headlines a few years ago when doctors at the University of Michigan (UM; Ann Arbor) saved an infant's life with a 3-D printed tracheal splint they sewed into his airways. That incredible procedure gave hope to the parents of baby Garrett Peterson who suffered from a similar bronchial condition. Earlier this year, the same team of UM doctors made a custom-designed, custom-fabricated device for the Peterson baby using high-resolution imaging and computer-aided design. The device was created directly from a CT scan of the baby's trachea and bronchi, integrating an image-based computer model with laser-based 3-D printing to produce the splint.

And while we try to grapple with the potential impact this technology could have in the medical arena, one man can't get 3-D printing out of his head. The man, whose name has never been publicly disclosed, had 75% of his skull replaced with a 3-D printed implant made by Oxford Performance Materials (Connecticut). 3-D printing has also been used to build part of a jaw for a patient in France, and even to rebuild a man's pelvis after it was destroyed by bone cancer.

But the impact of 3-D printing is being realized far beyond the operating room as engineers are beginning to understand the boundless possibilities that 3-D printing offers for manufacturing.

"Where 3-D printing is going to change the medical device industry is speed to market, reproduction, and the cost of scaling up a business," Matt Hlavin, president of Thogus (Avon Lake, OH), told MDD.

Thogus is already using 3-D printing to break through the confines of traditional manufacturing for its customers in the medical industry. The company has printed patients' skulls for surgeons to use prior to surgery, as well as devices used in orthopedics and other areas of healthcare. This can have a tremendous impact on healthcare costs, he said.

Using the example of how trauma surgery is performed in most hospitals today, he said the surgeons are using a CT image and looking at a screen in 2-D while working on a 3-D patient. With 3-D printing, companies like Thogus can print a customized scale model of that patient's skull in less than 24 hours, enabling the surgeon to disassemble and re-assemble the 3-D "puzzle" in the operating room.

"The surgeon in the room is like a general on a battlefield," Hlavin said. "If you know what the battlefield looks like, you know where to deploy your troops."

The technology also has the potential to reduce the time it takes large healthcare imaging companies to develop new CT machines, Hlavin said, because 3-D printing will allow manufacturers to consolidate parts. Instead of a machine comprised of 300 components, it may only be 30 components with the help of this revolutionary technology.

And any company that has ever taken a medical device through the U.S. regulatory process understands the investment of both time and money to bring a new product to market or even just to develop a prototype. Hlavin said 3-D printing enables companies to have parts manufactured as needed, rather than mass produced. He said his company helps its customers reduce unnecessary steps, cost and time to market by using what the company calls rapid prototyping plus manufacturing (rp+m). This solution helps business take a project from concept to production within days and sometimes even hours.

For example, he said, a customer could say I need this product today and it's 8:45 in the morning but I only need three, I don't need 300 and that's the kind of service 3-D printing enables. "The whole financial model changes, shelf-life model changes," he said.

Another Ohio company using 3-D printing methods to help entrepreneurs create 3-D models of their ideas is Dragon ID (Shaker Heights, OH), an R&D firm. Eugene Malinskiy, the company's CEO, told MDD that Dragon ID often has doctors or other innovators approach the company at various stages of the design process, wanting to have three or four different versions of their invention produced so that they can try it out in cadavers. Doing this would be way too inefficient and costly for most traditional manufacturers, but 3-D printing makes it possible. Dragon ID is able to use this technology to cut down the prototyping time and take a product from blueprint to use in cadavers in a matter of days or weeks instead of months.

Medacta (Castel San Pietro, Switzerland), a Swiss orthopedic company, also sees the value in using 3-D printing. The company offers customized orthopedic implants as well as patient-specific models for surgeons to use for pre-operative planning or even intra-operatively.

Chris McAuliffe, director of Medacta's spine business, told MDD that on his first day with the company he was in Europe watching an adolescent scoliosis surgery in which Medacta's technology was put to use. "To see the level of confidence and preparedness for an extremely complex procedure . . . I had never before seen an OR surgeon and staff in scrubs so certain about how they were going to enter the case," he said. With the help of Medacta's technology, he said, the surgical team had everything they needed for surgery laid out in advance, including models and anatomical surgical guides. "It was such a high degree of confidence, I think we probably minimized the intra-operative imaging and radiation exposure by like 80% or 90%," he said.

According to a recent issue of Biomedical Instrumentation & Technology, the peer-reviewed journal of the Association for the Advancement of Medical Instrumentation (AAMI; Arlington, VA), several facilities are using 3-D printing methods for all sorts of routine uses. For example, the AAMI article noted, at the Minneapolis VA Medical Center, Steve Morin, the facility's in-house "instrument maker" has used 3-D printing to create a wall-mounted radon test canister holder, prototypes for the prosthetics research investigators, and other items. Morin said the technology helps the medical center keep lots of equipment in service long after support from the original equipment manufacturer has ended.

But opportunity in the medical field often is accompanied by an assortment of hurdles and 3-D printing is no exception. Before 3-D printing is fully adopted for medical use, the industry has to tackle a host of regulatory, financial, and legal challenges.

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