Medical Factories

The rapid adoption of 3-D printing is turning hospitals into production centers that help improve surgical outcomes, enhance training, and limit medical stays.
Dr. Kongkrit Chaiyasate holding infant skull
Dr. Kongkrit Chaiyasate of Beaumont Health prepares for a recent surgery by examining a 3-D printed model of an infant’s skull. // Photograph courtesy of Beaumont Health

They haven’t started wearing industrial coveralls over their white lab coats and scrubs, but 3-D printing is turning doctors and medical practitioners into manufacturers, and their offices and hospitals into factories.

About 200 institutions nationwide, including Henry Ford Health System in Detroit and the University of Michigan in Ann Arbor, have set up in-house 3-D printing centers to produce medical equipment and health care components via a layer-by-layer technique, also known as additive manufacturing.

In March, Henry Ford Health System treated its 1,000th patient using 3-D printing technology. Recognized as a leading player in adapting the technology for planning complex heart procedures, Henry Ford  Health uses 3-D printing for planning treatments in cardiology, vascular aneurysms, oncology, cranial-facial reconstruction, and orthopedics.

“When you can hold it in your hand it becomes more intuitive rather than just (seeing it)on a screen,” says Dr. Dee Dee Wang, a cardiologist at Henry Ford Health. “Our brains understand that better, and that’s invaluable for a surgeon going into a surgery or a cardiologist going into a procedure.”

The output at these medical-facilities-turned-factories include patient-specific cutting and drilling guides for surgeries, prototypes of medical instruments, and implants for animal research. Medical personnel are also fabricating 3-D printed, full-size anatomic models using a patient’s CT, MRI, or ultrasound data and specialized software.

The models are used for planning complex surgeries, including creating sizing devices and implants to be used in those operations, teaching medical students and doctors in training, and educating patients.

As a result, surgical teams are better prepared and can work more efficiently across many medical specialties. Pre-surgery production and subsequent training reduces human error, surgical time, and costs. The anatomic models also help foster better communication among health care professionals and patients. “There’s growing evidence in medical literature about the value of 3-D printing,” says William Weadock, a professor of radiology at the University of Michigan.

Making the models in-house, also known as at the point of care, offers cost savings, more control, and other benefits over using a 3-D printing vendor.

Medicine is the next logical area for 3-D printing to move into because we’re not all cookie cutters. — Shawn O’Grady, Digital Fabrication Specialist

As an example, the Washington University Medical Campus in St. Louis outsourced 136 models, mostly for surgery, in 2017 and 2018 at a cost of $343,000. Of those models, 108 were for plastic and reconstructive surgery, and cost $239,000.

A subsequent analysis determined the health system could save almost $105,000 overall, or roughly 30 percent, by making the models in-house. For plastic surgery cases alone, the savings rate is 38 percent.

Southeast Michigan health systems, including McLaren Health Care in Grand Blanc and Beaumont Health in Southfield, still depend on vendors to do 3-D printing for them, but that’s about to change.

Beaumont Hospital in Royal Oak has a 3-D printing center in the works that organizers hope will serve all eight Beaumont hospitals starting in 2020. “By having it in-house it becomes more available and you don’t have to wait as long to get your model (produced),” says Dr. Elvis Cami, a Beaumont cardiologist who subspecializes in cardiac imaging. “I think you have the opportunity to learn more about when you might need it. I think in the long run, from a financial standpoint, it will probably be cheaper.”

Cami estimates it would cost about $750,000 to set up a center at Beaumont and run it for three years. The money would cover the costs of a printer and supplies, licensing software, renovating an existing space, and staff salaries. He says a colleague is in touch with a potential donor for funding, and Cami is working with Materialise, a 3-D printing software provider located in Plymouth Township, to assist with the setup.

While Beaumont waits to start up its own printing facility, Cami has been the ad hoc facilitator in his department for obtaining half a dozen heart models at a cost of $2,100 each from Materialise since 2017. He uploads heart imaging data and then consults electronically with one of the vendor’s biomedical engineers to identify exactly which part of a patient’s anatomy should be printed. The firm prints the patient-specific replicas at its headquarters in Belgium.

Ken Richey, founder and operations manager of Beaumont’s 3-D simulation lab, has been using Materialise’s software for several years to help doctors visualize internal anatomy on a computer screen. “I use it for surgical simulation, but I could just as easily do the setup for 3-D printing,” Richey says. He’s also eager to see the technology set up in-house. “We’re salivating because we’re so close,” he says.

So far, Materialise is the only company to gain U.S. Food & Drug Administration clearance to use its software, along with select printers and materials from its partner Stratasys, a manufacturer of 3-D printers in Eden Prairie, Minn. The products are approved for diagnostic use with orthopedic, cardiovascular, and maxillofacial — or jaw and face — applications. It also recently received a clearance for software to support structural heart and vascular therapy.

heart model made on 3-D printer
By 3-D printing a patient’s heart, cardiologists can better prepare for surgery.

While Materialise has been 3-D printing guides for orthopedic surgeries for several years, the company is interested in providing solutions to hospitals such as Beaumont for enabling point-of-care printing, says Bryan Crutchfield, vice president and general manager for North America at Materialise.

“The typical continuum will start with an interested facility trying some test cases with us,” Crutchfield says. “We’ll actually do the segmentation (digitally selecting relevant anatomy) with them interactively, produce the models, and send them back.”

That initial exposure usually inspires other applications. “We start (asking them), Do you want to set this up as your own center of excellence inside your facility?” Crutchfield says. “Many times, they’ll still start with the software, and may not necessarily do the printing themselves. And then, eventually, they’ll start printing.”

As the practice of medical 3-D printing grows, doctors like Cami’s colleague, Dr. Kongkrit
Chaiyasate, a Beaumont craniofacial and pediatric plastic surgeon, realizes the benefits of personalized anatomic models. “I have no doubt it increases the accuracy of the procedure,” says Chaiyasate, who’s used 3-D printed models from vendors since 2011.

The new technology has cut the time Chaiyasate spends on a case in the operating room to an average of two hours, compared with six hours, he says. Cutting the time spent under anesthesia is important for anyone, but it’s critically important for babies because it can affect their cognitive development.

What’s more, at $200 to $300 per minute for operating room time, the savings can add up quickly. The price drop, however, is partially offset by the almost $20,000 for anatomic models, cutting and plating guides, and bioresorbable plates and screws he orders from KLS Martin in Jacksonville, Fla. The plates and screws are used to temporarily hold together the pieces of skull the doctor has cut. Over time, the plates and screws dissolve as the bone grows.

A downsides of in-house 3-D printing is that it takes business away from vendors and may lead to doctors who were early adopters, like Chaiyasate, ending existing relationships and starting fresh with a new biomedical engineer. “They know my style,” Chaiyasate says of KLS Martin. “They make my life so much easier.”

As with many new technologies, acceptance isn’t universal. “When we present it at national meetings, it’s still very controversial,” Chaiyasate says.

medical devices and 3-D printed infant skull models
The FDA is trying to keep up with the rapid developments of medical 3-D printing. // Photograph courtesy of Beaumont Health

Even so, Gartner — a research and advisory company — forecasts that by 2021, 25 percent of surgeons like Chaiyasate will practice on a 3-D printed model prior to surgery. In a 2017 international study, almost 50 percent of surgical cases for complex congenital heart disease changed as the result of a 3-D printed model.

Dr. Glenn Green, an ear, nose, and throat surgeon at Michigan Medicine, also uses bioresorbable 3-D printed devices, but his are used to prop open babies’ airways until their normal anatomy can develop.

“We print thousands of parts per year,” says Shawn O’Grady, a digital fabrication specialist at the University of Michigan’s Duderstadt Center. “Medicine is the next logical area for 3-D printing to move into because we’re not all cookie cutters.”

As the technology is more widely used, rule-makers from medical societies, government, and health care organizations are trying to catch up. In 2017, the FDA issued guidelines for 3-D printing of medical devices, and federal regulators had previously cleared bespoke cranial patches and Green’s infant airway splints on a case-by-case basis.

At an additive manufacturing trade show last spring at TCF Center (formerly Cobo Center), FDA representatives discussed various regulation-related setups for 3-D printing. They talked about issues including who would assume risk, patient privacy, and the level of participation by industry, among other topics. Government personnel made it clear they were in the early discussion phase of future regulations.

At the same trade show, scientists from UL, formerly Underwriter Laboratories, talked about precautions the organization issued earlier this year for people to work safely around the harmful chemical vapors and dust that some 3-D printers emit.

Independent of the FDA and UL, in 2018 the Radiological Society of North America published an initial ranked list of what medical conditions and procedures do and don’t merit a 3-D printed anatomic model. In general, the more complex an injury or condition, the more a 3-D printed replica is called for, according to the list. It also hints at conditions, such as kidney stones that need to be removed surgically, that may be future applications for anatomic models.

In the meantime, 3-D printing technology keeps advancing and becoming more useful for doctors, especially with the advent of printers that can use multiple materials and different colors in one anatomic model to mimic the complexity of the human body.

Specialized Talent

At a recent additive manufacturing trade show at TCF Center in downtown Detroit (formerly Cobo Center), a recurring lament from those involved with setting up 3-D printing centers in hospitals was how difficult it is to find qualified workers to staff them.

Hospital-based, or point of care, 3-D printing is new in health care and ripe with opportunities. But where in southeast Michigan can would-be workers get the training they need for a job in this emerging field?

David Darbyshire, an engineer and co-owner of DASI Solutions, a 3-D printing contractor in Pontiac, says an associate’s degree is a perfect fit for anyone interested in starting out. He says even a high school technical program graduate with some experience in 3-D printing, computer-aided design, mechatronics, and machinery operations may be attractive to an employer. “Those are the kids I would snatch up,” Darbyshire says.

He also recommends attending RAPID + TCT, the 3-D printing — additive manufacturing — annual trade show sponsored by SME (formerly known as the Society of Manufacturing Engineers) in Southfield.

SME, in collaboration with UL (formerly Underwriter Laboratories), also offers a certification program — Master the Principles of Additive Manufacturing. The program is self-directed, ends with a written exam, and offers two levels of certification: fundamentals and technician.

The certification offers a blueprint for the body of knowledge needed to get started in the growing field of 3-D printing manufacturing, including at the point of care, says Jeannine Kunz, vice president of Tooling U-SME, the training and development division of SME. “There’s a lot of noise, a lot of options, but not all options have a clear path forward,” Kunz says. “This does.”

Across the region, Wayne County Community College District offers an associate degree of applied science in product development prototyping. The school also provides a short-term certificate for 24 credit hours, compared with the 60 hours required for a degree.

“These are stackable credits,” says Dr. Shawna Forbes, vice chancellor of continuing education and workforce development at WCCCD. “You may get the certificate, get a job in the field, and realize you’re on a good career path, then go on to earn the higher degree.”

Forbes says the institution is also responsive to industry and its requirements. If a company needs employees with a particular set of skills, WCCCD can work with corporate leaders to develop a curriculum and provide training to its workforce.

Lawrence Technological University in Southfield teaches 3-D printing in its mechanical engineering program. It also has undergraduate and master’s level programs in biomedical engineering that include additive technology training.

“Many senior design teams use 3-D printing to create prototypes of their design, which are all biomedical related,” says Yawen Li, chair of the biomedical engineering department at LTU. “For example, two senior design teams collaborated with the simulation lab at Ascension Providence Hospital (in Southfield) to create an IV and arterial line vascular arm model, and an intubation blade with embedded electronics (to measure the pressure applied), which were tested by residents. That’s incredibly novel.”

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