Materials The applications of PEEK implants Skull prosthesis
Maxillofacial prosthesis Clavicle prosthesis
Rib prosthesis
Interbody fusion cage
Orbital prosthesis Mandible prosthesis
Sternum prosthesis
3D printing regulations are not as simple as for traditional manufacturing, due to the many parameters, systems and materials that need to be characterised and controlled under existing regulatory frameworks. To obtain FDA clearance, the complete workflow typically has to be validated, including the image-processing and modelling software, the 3D printing system, the qualified medical-grade PEEK material and the predefined production process.
Knee prosthesis
Regulatory considerations for 3D-printed PEEK implants Gaining regulatory approval for implants made by 3D printing is more difficult than for off-the- shelf implants that have a standard design. While conventional mass-produced implants only need regulatory approval for one design and its manufacturing process, personalised devices require regulatory clearance across a wider design envelope because the geometry may vary depending on the patient.
Source: ‘Recent Advances in PEEK for Biomedical Applications: A Comprehensive Review of Material Properties, Processing, and Additive Manufacturing’
high degree of design freedom and the ability to produce complex geometries are helping many patients obtain more efficient, comfortable and longer-lasting implants. 3D-printed implants are fixed in place using traditional bone screws and/or plates depending on the surgeon.
This technique has been used for a wide range of medical implants, including polymers and metals such as titanium. These technologies allow the development of fully personalised implants capable of incorporating complex geometries, particularly in the craniomaxillofacial (CMF) and cranial reconstruction space.
“Taking PEEK raw powder or filament and turning it into a fully fused part can change the microstructure and therefore the effective properties of the material, but it is more flexible.”
However, PEEK is not the easiest material to work with, but its properties have meant that significant interest has emerged in creating 3D-printed PEEK implants. This development underpins the first FDA-cleared workflow for a 3D-printed, patient-specific PEEK cranial implant.
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The FDA has developed guidance documents for additively manufactured medical devices that set out considerations for manufacturers, because 3D printing is still considered a relatively new manufacturing approach compared with more traditional manufacturing methods such as milling. One of the big differences is that when material is purchased for traditional manufacturing, it typically comes with certification of defined material properties and compliance with relevant standards. Manufacturers simply remove some of the material from the bulk material to make the device and it will meet regulatory requirements. However, it is not as simple for 3D printing. Because the material’s final structure is created during the printing process, manufacturers must demonstrate that the printed construct meets the required material specifications, mechanical properties and performance for the intended end product.
So, there are many things that need to be considered from a regulatory perspective, but the foundations towards approval from the FDA and other regulatory bodies are there and companies need to adhere to the guidelines. Although that sounds simple, it is not, because alongside validating all the materials and the equipment, 3D printing involves many different process parameters that need to be controlled, which are different from and more extensive than those used in traditional manufacturing methods.
So, to obtain evidence that the intended specifications have been met for regulatory approval of PEEK implants, companies will need to carry out extensive validation of their raw materials, manufacturing equipment, process parameters and the specifications of the end product.
www.medicaldevice-developments.com
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