Steve Cockcroft pulls no punches. Canada is home to some of the top researchers in valve replacement technology for heart disease, yet remains "significantly behind the eight ball on the manufacturing side of that equation," according to Cockroft, a materials engineer at the University of British Columbia (UBC). He told Medical Device Daily the problem is especially dire in the additive manufacturing sector. "We're way behind in Canada," he said.
UBC's materials engineering department is trying to gain a foothold in the area of laser-based and electron-based additive manufacturing systems, but the effort hinges on a $20 million grant application currently under review by the federal government.
"Right now the critical piece we're missing is the state-of-the-art equipment," Cockcroft said.
The other piece is persuading medical practitioners that engineers can deliver technical solutions to complex medical challenges when asked for them. "It takes a long time to establish your credibility as an engineer in the medical field, and there are people who have definitely done that, but they've done that by building those partnerships," he said.
Looking for an edge
Canada may be behind the curve in additive manufacturing, but not for lack of effort. Last year, Ottawa forked over $5 million to the new Advanced Digital Manufacturing Hub in Winnipeg, which prototypes advanced orthopedic materials through additive manufacturing.
The city also houses the nation's most advanced ISO registered design and manufacturing department at the Division of Medical Physics at Cancercare Manitoba.
"Getting ISO certification in a health care environment is very difficult," Cancercare's Medical Physics Director Jeff Bews told Medical Device Daily. "A commercial company definitely goes after it. A public health care facility struggles because introducing ISO requirements requires resources."
Bews manages four departments in radiation therapy and protection, diagnostics imaging, electronics, and medical device fabrication. His clients include physicians at the University of Manitoba's Department of Medicine and St. Boniface Hospital. A surgeon may take a problem to Bews, for example, kick starting an entire process of research, design, and manufacturing aimed at specific medical solutions for individual patients.
A case in point: a polymer based mandible to help surgeons reconstruct the jaw of a cancer patient. An imaging technician first shapes the CT image of an artificial mandible and prints it off into 3-D polymer plastic. For support, titanium metal is bent and screwed on to the mandible and two jigs printed off which oncology and plastics surgeons use to cut and shape the mandible to the contours of the patient's original jaw.
"The physicist comes up with a new idea," said Bews, "and we keep working on it until we get to a point where we don't think there is anything more we could possibly do to provide benefits."
Hospitals look inward for solutions
Of increasing interest among Canadian hospitals is in-house custom design and manufacturing. One particularly ambitious example is Toronto Sunnybrook Hospital's 2,000-square foot advanced machine shop, specializing in 3-D designed catheter-based and MRI-compatible devices, prototypes, and custom-made parts. According to shop manager Michael Pozzobon, these include high-end, industry standard machines, such as a five-axis water jet cutter.
"Our machine shop was originally designed for the research group," Pozzobon told Medical Device Daily. "But over the years we expanded our work into other departments within the hospital based on our equipment and expertise." This makes it "a lot quicker, easier, and cheaper" than going outside for medical device solutions, he added.
Pozzobon used the example of the shop's rapid prototyper to manufacture a device for the treatment of penile cancer. "The option was removing the penis or severe disfiguration," Pozzobon said. But the shop came up with a far more desirable solution – making a mold of the penis, surrounded by a circular tube containing radioactive seeds, which eliminated the tumor in three patients. "We would never have been able to do this without a rapid prototyper," said Pozzobon.
For his part, Dale Kellington, vice president of business development at Concordia Hospital's orthopedic innovation center in Wnnipeg, said plastics represent the bright side of additive manufacturing in Canadian hospitals. But its future lies not just in fast turnaround, customized devices, he told Medical Device Daily, "but in actual production runs of larger quantities of devices that help pay the bills."