Back in 2013, Oxford Performance Materials’ biomedical division got FDA clearance for the first 3D polymeric implant for cranial reconstruction. A year later it won clearance for its 3D printed facial device.
What makes them unique is that they are patient-specific. In fact, OPM Biomedical is the first and only company to receive FDA 510(k) clearance for 3D printed patient-specific polymeric implants and has a total of four 510 (k) clearances. In doing so, the company is merging two trends in the medtech world – the demand for patient-specific implants, especially in orthopedics and the wider use and interest in 3D printed medical devices.
In fact, the overall, global 3D printed medical devices market is projected to reach $1.88 billion by 2022 from $840 million in 2017, at a compound annual growth rate of 17.5 percent, according to a report by Research and Markets.
Since the first cranial implant clearance in 2013, OPM has shipped close to 1,500 cranial implants, said Severine Zygmont, president of OPM Biomedical in a recent interview. She noted that unlike implants made through conventional manufacturing processes, the company’s 3-D printed process can handle complex implants without adding costs.
The implants could be complex from a geometry perspective involving channels, lattice structures, and organic shapes for example, which would make them either impossible to be produced using traditional machining, molding, and casting techniques, she said.
“If even possible using such conventional processes, it would cost a fortune,” Zygmont declared adding that it may require additional assembly, welding, and post processing.
The other advantage of 3d printed implants is that large implants can be made in one piece.
“For some cranial implants, you would have to make as a kit if you have to do a very large reconstruction,” she explained whereas the South Windsor, Connecticut company can do it as a single device. “So that’s very unique and there’s really no other way to do it today. You would not take a big block of plastic and machine a large implant out of it.”
Anecdotally, the company’s representatives have heard that this ability saves time in the operating room, which naturally also saves money.
“We have been told by surgeons that if you have a large cranial reconstruction, you don’t hvae to spend time in the OR to put the implant together. So you save time in the OR,” she said.
And less time in the OR is not just about good economics, it’s is also better for patients. They have to spend less time under anesthesia, for instance, Zygmont explained.
The complexity could also come from several design iterations. In conventional manufacturing, each new design iteration requires new tooling, which can cause delays and add to costs.
“[In 3D printing], design iteration doesn’t require new tooling and setup like it is required for injection molding or machining from extruded shapes,” she pointed out.
Zimmer Biomet distributes the company’s devices, but Zygmont declined to say how much the implants cost. She would only say that price has not hindered the adoption of the devices.
OPM’s competition is still the status quo of established medical device makers who use traditionally manufactured implants.
But even they are realizing the potential for 3D applications in many different implant procedures. At Stryker, for instance, certain parts that are needed for total joint replacements are 3D printed. The Kalamazoo, Michigan company has also invested in a 3D manufacturing plant in Ireland.
For OPM and Zygmont, 3D printing has liberated the surgeon.complexity is free. We are able to manufacture
“Complexity is free,” she said. “We are able to manufacture a design that surgeons thought of but could never make without adding cost or complexity or time which ultimately add costs.”
Photo: Oxford Performance Materials