3D Systems

www.3dsystems.com

Littleton, Colorado (headquarters: Rock Hill, South Carolina)

Founded: 1986

Publicly traded (NYSE: DDD)

Employees: 2,500 globally; 150 in Littleton

Industry: Bioscience & Medical

Products: 3D printers and virtual surgical planning

VP of Medical Devices Katie Weimer is guiding the development of cutting-edge technology that's revolutionizing healthcare.

When Colorado native Chuck Hull envisioned 3D printing more than 30 years ago, he didn't foresee how the technology could be used in a hospital operating room. But now his invention has started to have a big impact in the medical world.

Hull, born on the Western Slope in Clifton, and a graduate of the University of Colorado, invented 3D printing in 1983 using a solid printing process known as stereolithography. That's the name he gave the process when he was issued a patent three years later, referring to the creation of 3D objects by "printing" thin layers of a plastic object on top of each other, with the layers hardened using ultraviolet light. Hull also co-founded 3D Systems, which is based in Rock Hill, S.C., to commercialize the technology.

The 3D manufacturing technology quickly found a home in the automobile industry making prototypes of things like door handles. Its uses continued to expand into many fields and has become inexpensive enough that 3D printers are found in hobbyist homes. Most astonishing for Hull, though, has been the use of the technology in medicine. In an interview with CNN in 2014, Hull said he had been most surprised by the use of 3D printing in the healthcare industry.

It was 2014 that Hull was inducted into the National Inventors Hall of Fame. Also that year, 3D Systems acquired three companies that make up what is now the company's healthcare business, which is based in Littleton. Those acquisitions included Medical Modeling of Littleton, Simbionix of Israel, and Layerwise of Belgium.

Katie Weimer, vice president of medical devices at the Littleton facility, agrees with Hull's assessment of 3D printing's importance for treating medical patients. "It has transformed how surgeons operate now," she says. "But we're just at the beginning."

One of the first uses of 3D printing in medicine was in 1996 when the technology was used to help surgeons in Texas separate a pair of conjoined twins. When a model of the girls' bone structure was built with a 3D printer, surgeons noticed that a shared upper leg bone was bigger than the expected, allowing them to split the bone so that both twins could walk.

Weimer says two of the division's core competencies are anatomical modeling and "virtual surgical planning." The former uses data provided about a patient's anatomy to build an accurate model that can be used to plan a surgical procedure. The latter uses online data about the patient to allow a geographically widespread surgical team to plan and virtually carry out a surgery.

Virtual surgical planning (VSP) lets the surgical team print out templates and surgical tools for a specific patient and operation. Plans that are created virtually are then used in an operating room.

An early use of VSP was in surgeries to help repair extensive facial deformities for a young Zambian girl named Grace. The child was born with eyes extremely wide apart, severe facial cleft deformities and the lack of a bone separating her brain from her oral cavity.

A surgical team led by Dr. Kenneth Salyer of Dallas worked with the 3D Systems VSP technicians to produce models, guides and templates specific to the girl's anatomy. Virtual surgical planning brought together Salyer's team from Washington, D.C.; Cape Town, South Africa; Jacksonville, Fla.; Tuttlingen, Germany, and Belgrade, Montana. An implant was created to help her skull form new bone.

"Planning the surgery for Grace was particularly demanding," according to Shawn Burke, director of product development for the medical device company KLS Martin North America. A 2012 case study quoted Burke: "Unlike many cases, Grace was missing a large volume of bone, making it a challenge to create a reconstruction that is strong enough but goes away and allows for the patient's own bone to grow. The other challenge was the six teams from three continents that had to be able to see and interact with the 3D simulations in real time. This was truly a multinational effort and solution coordinated by 3D Systems."

Weimer says VSP now generates the most revenue for the 3D Systems healthcare division, although the fastest-growing revenue generator has become the use of 3D printing to manufacture objects like titanium implants. The technology of 3D printing with metal has become more stable and costs are declining, she says, so much so that it is transforming medical device companies.

As an example, a German manufacturer, Emerging Implant Technologies, is using 3D printing exclusively to make orthopedic implants. Using 3D Systems' Direct Metal Printing technology, EIT recently manufactured a titanium fusion implant for a patient with a degenerative cervical spine condition.

"We're starting the see a generation of engineers learning how to design [products] for 3D printing," Weimer says. Instead of just designing prototypes with 3D printing, engineers are using the technology to produce larger numbers.

Even though 3D printing has been used for decades, its medical uses are so new that government regulators are still learning how to deal with it. Weimer says the Food and Drug Administration has released guidance documents that could lead to regulations governing medical insurance reimbursement for the cost of 3D implants.

3D Systems also recently started a certified partner program for companies utilizing additive manufacturing for medical devices. The first partner in the program is Minnesota-based rms Surgical. A subsidiary of Cretex Medical, rms manufactures medical implants using 3D Systems' Direct Metal Printing technology.

Challenges: "Keeping up with the growth in the industry," says Weimer. "It's such a hot market right now and we spend a lot of effort keeping up with demand."

Opportunities: "There is a huge opportunity in [solutions for] surgery, surgical correction and reconstruction," Weimer says. Among these is 3D bioprinting, where human cells in a mixture are placed in a printer cartridge and printed layer-by-layer to preserve the cell function and viability. These can be used to research drugs and medications, as well as regenerating joints and ligaments.

Needs: FDA regulations. Until the FDA approves regulations governing aspects of 3D printing in healthcare, there are no reimbursement codes so that insurance can be used to help pay for 3D products like implants.