3D printing in healthcare has moved past just being an idea and is well on the way to mainstream use.
The capabilities of 3D printing appear to be a natural fit for the medical industry, where it is common to need custom, patient-specific designs as well as custom medical tools. Before jumping in to this arena, though, there are challenges in the use of 3D printers, and it’s important to be aware of the standards and approvals required in the medical market. Approvals can take years to obtain.
Noted Katie Weimer, vice president, Medical Devices, 3D Systems Healthcare, medical design using 3D printing is not just about the printer. It’s about the entire flow of the digital concept as it comes in through medical imaging data, gets processed, planned, designed and then eventually used in surgery. It’s a mind shift. Patient anatomy is very organic by nature. Thus, patient design can become very complex, requiring different software tools to handle the organic geometries.
Parts or devices made for a hip, for example, must fit within the surgery field and in the area of exposure. A hip prosthesis must maintain the right strength and the right function, and be contoured correctly for the patient for better long-term use. Most CAD packages don’t do well with such organic geometries.
Software is available to use to create 3D printable parts for these organic geometries. One is haptic design software. It provides a tactile sensation to the geometries on the screen, so instead of just clicking, you receive force feedback and are able to “touch and feel” the model.
As for approvals, there are different classifications of medical devices that may have different design burdens or regulation of design associated with them.
Class I examples would be a 3D printed scoliosis brace, a hand prosthesis or fracture casting. This class has the lowest level of regulatory burden and typically just requires registration in a good quality system.
Class II has more burden because there is typically more risk to the patient. 3D printing examples include osteotomy guides and positional guides. Class II devices typically only have limited patient contact.
Class III classification includes metal implants, an area that is quite popular now. This classification has the most regulatory burden because of the greater risk to the patient due to long-term contact. Often clinical data are required to accompany the registration. Many times it requires clinical data to be accompanied with the registration.
3D printed devices for medical use must typically be precise and accurate. Meeting this requirement requires controlling everything from the raw material put into the machine through to machine calibration. Keep in mind that how a piece is positioned on the platform can play a role in dimensional accuracy of the part.