“In the future, my prediction is that the time from patient consultation to implantation will go from weeks to days, and eventually to just hours. There will be a 3D printer in the corner of your operating room. If it does not perfectly fit, you will be able to print another one!” Dr. Mobbs said to Spinal News International this summer.
“Imagine having a complex fracture with an anaesthetised patient on the operating table, and while you are doing the exposure, the prosthesis is being printed. We will get there—it is only a matter of time.”
The neurosurgeon was recently in the news again for another 3D printed spinal implant. 33-year-old Evan Horvat of Wollongong has been dealing with intense nerve pain in his back and leg, due to a bulging disc and a major congenital defect that caused a joint in his lower spine to be abnormally shaped. As Dr. Mobbs puts it to 9 News in Australia, the unusual disc almost resembles a lunar landscape. The nerve pain is causing all kinds of problems for Horvat.
“It shoots down through the back and it goes running down my whole left leg, all the way into my feet and that’s just constant, every day,” Horvat said.
“I have three young boys. I can’t pick them up, I can’t play with them. I can’t work properly because of it.”
Dr. Mobbs knew that an off-the-shelf disc replacement would not be of much help to Horvat in fixing his condition and lessening his pain, so he suggested using a custom 3D printed implant instead, and turned to design automation software company 3DMorphic, and its 3DMPlato software, for help. The company uses a unique, optimized workflow that allows patient-specific instruments and devices to be designed very quickly – it starts by using existing designs, then adjusts them accordingly.
3DMorphic used Horvat’s CT scan to build a 3D model first, and then put its software to work altering a generic design to perfectly fit his anatomy. It can take hours to design custom medical implants, but 3DMorphic managed the feat in just 20 seconds. The implant was then 3D printed in titanium, and according to 9 News, the surgery was deemed a success, though it will still be a few more weeks until the post-recovery results are fully known.
Dr. Mobbs believes that these quickly designed 3D printed implants would greatly benefit urgent medical cases, like cancer patients.
“If you know you’re about to start an operation and the implant that you have is going to fit perfectly into that patient, the benefits are immense,” he said.
However, as positively as this story turned out for Horvat, these devices are not yet included on the Australian Register of Therapeutic Goods, which means they aren’t “subject to the same level of scrutiny.”
When asked by Spinal News International if there could be regulatory barriers to these sorts of customized 3D implants, Dr. Mobbs said, “Absolutely, yes. There is no current standardised framework for regulation of these implants. You may eventually get to a point where implants for various parts of the body need to reach certain mechanical loading parameters based on computer-aided design modelling. This has been a barrier to implementation, however, in my opinion, the benefits outweigh the risks of this technology at this point in time.”
This isn’t the first time we’ve heard about the Australian government having issues with 3D printed titanium implants. According to a spokesperson for the Federal Department of Health, the manufacturer or sponsor is still obligated to report any injuries, potential injuries, or malfunctions, regardless of how the device or implant made its way onto the market and if it is custom-made; the country’s Therapeutic Goods Administration (TGA) will be releasing a consultation paper soon on the issue of regulating 3D printed implants. The Australian Orthopaedic Association did acknowledge that 3D printing technology has helped advance the medical field, though it also made it clear that these kinds of devices are still regulated, since manufacturers must apply “a conformity assessment procedure” to the TGA.
Even if the 3D printed implant Horvat received isn’t properly regulated yet, it certainly seems to have helped relieve him of pain. To learn more, check out the 9 News video here.
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[Source/Images: 9 News]