As previously reported in relation to 3D printed pills and medical devices, product certification and qualification is a challenge to the progress of additive manufacturing in medicine.
In order to ensure new 3D printed hip implants meet stringent standards laid out by the industry, bespoke patient-care provider Baltic Orthoservice (Ortho Baltic) is implementing advanced 3D scanning systems for quality assurance.
A rigorous scanning system
Ortho Baltic’s product line includes a range of custom-made orthoses, footwear, 3D printed prosthesis covers and implants for improved patient care.
Hip implants at the company are custom-made using direct metal laser sintering (DMLS) technology. After 3D printing, the implants undergo a number of post-processing step to reach suitable standard for use in the body. These stages include heat treatment, surface polishing and custom-milling for screw holes as per the patient’s injury.
After each of these steps, the products are 3D scanned using a two-part system from Nikon Metrology.
70,000 points per second
Capable of collecting object imaging data at up to 70,000 points per second, Nikon Metrology’s ALTERA CMM is used to determine the surface of an implant. Using enhanced sensor performance (ESP), the device overcomes the key challenge of 3D scanners by capturing reflective and multi-material surfaces.
“The CMM with laser scanner is irreplaceable when we need to perform fast checks after each manufacturing and post-processing stage…” – Paulius Lukševičius, Engineer of Mechanics at Ortho Baltic
The XT H 225 CT by comparison is a form of non-destructive testing, and can tell the internal geometry of a part.
Both of the systems are used to make sure the 3D printed implant matches the design determined by its computerized equivalent.
Paulius Lukševičius, Engineer of Mechanics at Ortho Baltic, explains, “Patient-specific implants are a bespoke treatment solution, which means that the surgery must be ‘pre-planned’ virtually so the implant can simply be put in place.”
“The CMM with laser scanner is irreplaceable when we need to perform fast checks after each manufacturing and post-processing stage, especially to check spherical surfaces, bearing surfaces and hole angles.”
3D printing achieves recognition
Though qualification of new devices in the medical industry is necessarily stringent, new 3D printed implants continue to find a market in across the globe.
In addition to hip implants, supportive lumbar cages for the spine are also a particular area of interest in the industry, as are custom made devices that help surgeons make incisions and put screws in place.
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Featured image: 3D scanning a 3D printed metal hip implant with Nikon Metrology. Photo via Baltic Orthoservice