Recovering from surgery is stressful enough, even with all the necessary assistance. But a teenage patient in New York faced an additional challenge: She couldn’t reach the lock to release the leg support on her wheelchair.
Staff at Blythedale Children’s Hospital’s assistive technology department looked around their workspace—replete with circuit boards, tools, tubes and wires—and searched online for devices or attachments that could help, but they were coming up short.
“We tried to see if there was any solution available in the market,” said Andres Guerrero, a rehabilitation engineer at the 86-bed specialty children’s hospital in Valhalla, N.Y. The hospital works with medically complex patients ranging in age from infants to teens, so it can be challenging to find commercial equipment that’s the right fit.
Ultimately, the team couldn’t find anything that worked—so Guerrero began working on designing his own extension of the lock that was more accessible.
It’s one of the more complex projects Guerrero has taken on since coming on board as Blythedale’s first-ever rehabilitation engineer this past summer. Guerrero customizes assistive technologies for patients using mechanical, electrical and computer engineering—and, in this case, 3D printing.
For 3D printing, engineers use specialized software to create designs that are ultimately sent to a 3D printer. That printer, which isn’t cheap (Blythedale’s cost about $4,000), deposits thin layers of material to build a replica of the design.
It can take Guerrero a few weeks to complete a 3D printing project. It’s an involved process, including collaborating with patients, physicians, and physical, occupational and speech therapists to create an initial design, and then testing multiple prototypes before reaching a final result.
Then, even with a functional prototype, he might need to tap an outside company and collaborate to create the product if the hospital needs it made with a material other than plastic.
“It really depends on the difficulty of the project,” he said of how long it typically takes to finish a device. Blythedale follows a 2017 guidance on technical considerations for 3D-printing medical devices from the U.S. Food and Drug Administration.
Guerrero recently finished a prototype of the wheelchair extension, which he shared and tested with the patient. “The patient loved it, because she was able to actually use it by herself,” Guerrero said. That means he can move on to developing the final product.
Blythedale got its in-house 3D printing program up and running about four months ago, and it’s already proven useful. In addition to the wheelchair project, Guerrero has built simpler devices, such as customized ring splints for patients with hand problems, as well as adapting toys for children with special needs.
In-house 3D printing provides “immediate quality control,” Blythedale CEO Larry Levine said, since the hospital’s staff oversees the entire development and manufacturing process. It also saves time compared with outsourcing, since Guerrero can draw up an initial design, test it with the patient and then redesign in a matter of days if needed.
Levine said that adding a 3D printer wasn’t a cost-saving project, and was part of the hospital’s mission to “establish an assistive technology center of excellence for children.”
“At best this is probably a break-even venture—it maybe loses a bit of money,” Levine said. Patients aren’t charged for the customized technologies, and assistive technology is built into the inpatient rate that Blythedale negotiates with insurance companies.
In-house 3D printing has become more common at hospitals in recent years for various uses, in part because the design software has become more user-friendly, said Jaime Schlorff, a senior project officer with the ECRI Institute’s health devices group. In-house 3D printing can lead to safer and more effective devices, since they’re “truly personalized” and developed collaboratively with patients and the care team, she said.
But when a hospital moves into a manufacturing role in lieu of simply purchasing devices, it adds new responsibilities. She urges hospitals to follow established guidances, such as those from ECRI and the FDA, to ensure they’re setting up good quality-control procedures and appropriately preparing devices for patient use.
“Hospitals need to keep in mind that although 3D printing is a new technology that’s changing healthcare, the old rules for safe manufacturing still apply,” Schlorff said.
