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.
Image Credit: OPM Biomedical