UM has been researching medical 3D printing since 1996 under biomedical engineer Scott Hollister, but it wasn't until 2012 that Green and Hollister joined forces to develop the implantable airway splint.
"I had been looking for a solution for some time. There is a severe problem with a lot of kids dying around the country of tracheobronchomalacia," Green said. "We have done 15 procedures so far ... 13 have done very well. One died of cardiac disease; another child passed away because of lung problems.
UM has more than 30 printers in operation, with half in the otolaryngology department, and has printed out hundreds of models and implants, Green said. The most expensive is a $100,000 EOS 3D printer, which is used to make the implantable airway splints.
"We are working on more than a dozen devices in my area, ranging from surgical models for students and residents to practice on to implantable devices," said Green, noting that the medical education value of 3D will show dividends in the future.
Implanting the splints requires a special FDA emergency exemption, but Green said UM is working with the FDA to get approval for a clinical trial that would prove the airway splint's effectiveness. Success in clinical trials is a proven method to convince private and government payers to reimburse treatments, he said.
"If we were supported through reimbursement, it would make a gigantic difference," said Green, adding that many more patients could be helped using 3D. "All our initial work was supported by federal grants. A lot was self-supported through donors. We are starting to see some corporate involvement, device manufacturers putting money into it."
Green at UM said inserting the 3D airway splint in a child can save $1 million in future medical costs. But each time UM wants to operate on a patient it must get insurance approval that Green says takes up to 10 hours of staff time.
Beaumont pediatric plastic surgeon Kongkrit Chaiyasate, M.D, conducts about 50 craniofacial, or skull reshaping, surgeries each year on babies and young children under age one.
Known as the "champion" of 3D printing at Beaumont, the Thailand-born Chaiyasate said in his six years at Beaumont he has worked on cases ranging from faces mangled by a raccoon to gunshot wounds to children with deformed cleft palates.
"We see babies [a day or two old and up to a year] who have craniums that are not growing. In the old days, surgeons would eyeball it and then do cuts. Now we do a CT scan for diagnosis and then plan it out and use the plating guide" created using the 3D printer, Chaiyasate said. "It is a two-hour surgery with about four to six weeks for recovery."
Chaiyasate said surgeries are performed on babies who are born with joints between the parts of the skull that have fused prematurely, which can put pressure on the brain.
The CT imaging gives Chaiyasate information on where to expand the skull. It usually takes two weeks to get back the plating guides from Materialise or two other 3D printing companies that Beaumont uses.
While the costs are about $5,000 more for the 3D procedure, Chaiyasate said families are not billed extra. "The procedure saves money because of less time in the OR. Insurance gives you one payment for the hospital, and we fold the costs into the bill," he said. "There is no net financial [charge] for the procedure. We have higher quality and better outcomes for patients."
Chaiyasate's first case was Ramon Aguilar Jr. in 2012. Ramon was born with a craniofacial condition known as Goldenhar syndrome. "Ramon had a congenital defect. One side of his face was not the same as the other," he said.
The goal of the surgery was to reconstruct the right side of Ramon's face and his jaw to allow him to eat solid food. Ramon completed the surgery and at age 21 graduated from high school.
Chaiyasate also does about three surgeries per month — aided by medical 3D printing — to rebuild faces for patients who have cancers of the jaw. The four-hour surgery starts by cutting into the calf bone to get a replacement bone for the jaw.
"We use 3D [printing] to create a guide, a piece of plastic to snap the segment on, for the fibula and the jaw," Chaiyasate said. "It was an 18-hour surgery, but we do it now in four hours because of the planning."
Looking to the future, Chaiyasate said Beaumont doesn't yet place materials like 3D printed bones or joints in the body. "Skin grafts are the future. We have a long way to go to get there, but it's going to happen," he said. "The difficulty now is controlling the cells. They cannot be replicated in mass volumes."
Richey, who has been with Beaumont since 1998, said he recognizes the value of using specialized software and digital images to illustrate in color and in three dimensions patients' medical problems for surgeons.
"The surgeons love it. When you think about how much it costs in the OR — $250 per minute — the surgeons can sit at my desk in the lab and plan [their] surgeries," said Richey, adding that surgery time can be cut nearly in half.
A growing number of Beaumont doctors, including neurologists, pediatric surgeons, orthopedic surgeons, cancer surgeons and interventional radiologists, are using the 3D medical printing software that was developed by Materialise to plan out their procedures.