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3D printing, also known as additive manufacturing, has become a fascinating topic for those operating in the spinal surgery space and one that could potentially transform the industry over the next decade. Production of additively manufactured orthopaedic and medical implants is estimated to grow by 29% CAGR through to 2026, of which spinal fusion devices will be one of the fastest-growing segments.
Many medical device companies operating across orthopaedics are recognizing the potential of 3D printing and investing in the technology. For example, Stryker, an industry leader in 3D printed titanium implants, recently announced plans to invest €200 million in research, development and innovation at its facilities in Cork, Ireland. This investment includes the AMagine Institute, which is responsible for the development of 3D printed products for the spine, head and joints.
The potential benefits of additive manufacturing are being explored in many areas of orthopaedics such as assisting with diagnosis and surgical planning through the creation of 3D models of a patient’s anatomy. However, one area I have found particularly noteworthy and interesting is the application of 3D printing in spinal implants, which has resulted in the manufacturer of more complex, and patient-specific, implants.
Additive manufacturing has enabled patients to benefit from customized implants. Whilst off the shelf implants are suitable for many cases of spinal surgery, there are occasions where a patient requires more specific or severe reconstruction better suited to a customized implant. These include severe spinal degeneration or tumour site reconstruction. By utilizing additive manufacturing a spinal implant can be specifically designed and printed to fit a patient’s anatomy, providing a treatment option where reconstruction with a traditional implant would have been difficult or impossible. These devices also allow for a less painful and lengthy adaption process for the patient as well as a reduced chance of having to go through repeat surgery.
3D printed spinal implants are also being created from materials such as porous titanium, which has the benefits of being strong and durable as well as achieving faster bone growth and osseointegration than conventional PEEK implants. This allows patients to benefit from more long-term stability and a faster recovery time. I spoke to Chase Tipping, a Product Development Engineer from medical device company Osseus, for his perspective on how additive manufacturing is improving the adherence and growth of bone cells on implants: “3D printing allows us to create porous titanium implants with shapes and structures that could never be achieved with traditional manufacturing. These uniquely porous implants allow for the insertion of larger amounts of bone graft and open new space for bone to grow through compared to traditional implants. 3D printed titanium also gives us the ability to add nano-scale and micro-scale surface roughness that encourages bone cells to adhere to and grow on the implant. This combination of porosity and surface roughness allows 3D printed implants to take a more active role in the fusion process; encouraging bone to grow on, in, and around them.”
Whilst widespread adoption of utilizing tailor-made spinal implants is an exciting prospect this is being limited for several reasons. Firstly, the cost of making customized implants is high. The investment costs associated with equipment and software can reduce a hospitals ability to adopt the technology. As adoption grows and more companies invest in this innovative technology, it should become more affordable. The length of time it takes to design and print a customizable implant also gives rise to problems. In emergency situations, patients cannot afford to wait for a customized implant. According to Dr. Ralph Mobbs, a neurosurgeon in Sydney, Australia, who was the first surgeon in the world to implant a 3D-printed spinal implant: “To move this technology forward, there needs to be advances in software to speed up the CAD design process to make it accessible to spine surgeons anywhere.” It is hoped that in the future hospitals will have their own printers, which could help speed up the process to a couple of hours.
In addition to it currently being a costly and timely process, there is also no standardised framework for patient-specific implants to be approved due to the uniqueness of each implant. This issue means some surgeons are hesitant to use this approach as they don’t understand how to navigate the regulations. This will also limit the ability of hospitals being able to manufacture the devices in-house.
Lastly, as an executive headhunter specializing in the orthopaedics and spine sector, industry advancements like additive manufacturing can be limited by the availability of talent with particular skill sets. The way the process works currently relies on a spinal surgeon working closely with a computer-aided design engineer. This process involves a different skill set than operating with a standard implant. Additionally, if hospitals are looking to carry out the design and print of spinal implants themselves, they will need to invest in these engineers and training for surgeons to roll this out effectively.
Whilst it is unlikely 3D printing will be used for all patients requiring surgical implants in the short term due to the limitations listed above, the benefits it provides niche cases – whereby conventional methods are not a suitable option – cannot be denied and are worth the extra time and cost associated with such implants. Key factors contributing to the widespread adoption of 3D print technology include, more companies entering the market, more suitable regulatory frameworks and advancements in technology to reduce manufacturing time and cost. In the future, there is hope that implants could be available in hours and produced directly in hospitals. Lastly, training and support need to be given to surgeons to help encourage the adoption of customized implants as well as ensuring there is investment in professionals with engineering support.
If you operate in the orthopaedics market, I would be interested to hear how you think additive manufacturing will impact spinal implants and what other opportunities you feel this technology could bring to the industry – please contact me at email@example.com
Spineuniverse, 3D Spinal Implants: A Glimpse into the Future
THE LANCET Digital Health, Challenges in the Design and Regulatory Approval of 3D-Printed Surgical Implants: a Two-Case Series
3D Printing Industry, Stryker Allots Share of $225.8m to Develop 3D Printing R&D in Ireland
24-7 Press Release, Additive Manufacturing for Orthopedic Implants to Generate More Than $1B in Revenue Opportunities by 2026 Says New SmarTech Publishing Report