Ronak Shah and Sabyasachi Ghosh, of Future Market Insights, questions whether 3D printing technology holds the potential to transform the personalised manufacturing landscape of spinal organs for tumour replacement and complex deformity surgery
The disruptive capabilities of 3D printing technology, or additive manufacturing, are being leveraged in prototyping of dental implants and custom prosthetics. While this can be traced back to the 1990s, 3D printing technology continues to discover ample applicability in the medical and healthcare industries. Once an ambitious dream in the pipeline, additive manufacturing technology has come a long way, banking on several R&D ventures that have made it what 3D printing technology is today. The technologically-abreast healthcare industry is poised to leverage it to a degree that perfectly complements the ‘minimally invasive’ trend in the surgical space.
As the wave of personalisation hits the healthcare industry, medical personnel worm their way into the 3D printing technology landscape, in an effort to harvest opportunities available in enhancing the patient care journey with utmost convenience and ease. Given the complex anatomy and sensitivity of spine, it is challenging for surgeons to reconstruct deformed bones with ‘off-the-shelf’ implants, such as an artificial disc, and that’s where the biocompatibility of 3D-printed implants offers a personalised solution. 3D printing technology in spinal surgery; though in its infancy, holds enormous potential as it allows for the development of a prosthetic that could perfectly replace a fractured bone.
In recent times, surgeons are increasingly relying on 3D printing technology for intra-operative surgical guides, surgical planning, and customised prostheses to achieve stability of spine with enhanced implant properties, better patient outcomes, and reduced surgical time. Since the success of the surgery depends on the accurate planning given the complexities associated with surgeries, surgeons acquire MRI and CT scans of a patient’s spinal cord. These scans help them design 3D virtual models of the deformed/damaged bones, which are the used in the development of their ideal replica by using a 3D printer. With a 3D-printed implant, surgeons are able to successfully resect the fractured bone and attribute stability to the spine.
The quest for a suitable implant material
Since the consistency of bones, along with their shapes and sizes, vary from patient to patient, manufacturers are transforming the 3D printing process by leveraging material distortion, liquid solidification, and powder solidification to achieve the desired form of the model. However, with varying fatigue limits of biological tissues and implants, manufacturers need to pull up their socks and undertake research and development initiatives to mimic the elasticity and tolerance of biological tissues and implants by experimenting with various materials.
Metals such as gold, titanium, cobalt and stainless steel have been gaining popularity for the development of permanent prostheses with high strength and elasticity; however, incompatibility with magnetic resonance imaging (MRI) continues to take a toll on their eligibility as ideal materials.
Ceramics, such as calcium phosphate, metallic oxides, and glass ceramics, are considered favourable for the development of implants, owing to their biocompatibility and bioactivity. However, even ceramics fail to match the designated properties of a human bone with their low fracture rigidity, which accounts for their incompetency as a material of choice for load-bearing applications.
Polymers, such as polyhydroxybutyrate (PHB), polyglycolide (PGA), polylactide (PLA), polymethyl methacrylate (PMMA), and ultrahigh molecular weight polyethylene (UHMWPE), are witnessing a high rate of adoption for the development of soft implants; however, their high degree of flexibility makes them weak for ensuring spinal stability.
The recent breakthrough in alloplastic material – polyetheretherketone (PEEK), a semicrystalline linear polycyclic aromatic thermoplastic – is deemed viable for replacing damaged spinal anatomy, in light of its chemical resistance, high fatigue tolerance level, light weight, high yield strength, durability, high temperature performance, and stiffness.
’Limited’ adoption despite high success rate
With the spine being one of the most sensitive parts of human body, a significant number of surgeons and patients continue to show reluctance towards the adoption of the technology. In addition to the low intelligence pertaining to the safety of this procedure, there are three barriers that fence the adoption of 3D printing technology for spinal surgeries.
The cost of off-the-shelf implants is comparatively less than that developed using a 3D printer, as the former is manufactured in batches, which significantly controls the overhead costs. However, the design and development of 3D-printed implants differ from case to case and patient to patient, which accounts for a higher price point. In recent times, with health insurance companies rolling out favourable reimbursement plans, the blow of the high cost of the spinal surgery procedures can be cushioned, which is likely to create a favourable scenario in the near future.
The 3D-printed implants are tailor-made for specific deformity or damage, which requires an MRI or CT scan to identify the issue and ideal structure of the bone. Surgeons then need to virtually plan the design of an implant using computer-aided design software and then, develop the design using 3D printers. The time-consuming process of scanning, designing, and developing prosthetics remains a longstanding challenge restricting adoption of 3D printing technology. In addition, 3D-printed implants are infeasible to develop in case a patient needs urgent surgery.
With the healthcare industry being under stringent scrutiny of regulations, currently, the patient-specific implants are still stuck midway in terms of approval. With the lack of a standardised framework, 3D-printed implants are far away from realising their full potential in a human body, which has been causing a reluctance among medical technology companies and surgeons.
What next for spinal surgeries?
The 3D printing technology holds the potential to transform the personalised manufacturing landscape of spinal organs for tumor replacement and complex deformity surgery. With increasing efforts in education and awareness of the use cases and success rates of these implants, the future is highly likely to spectate the convergence of spinal surgeries and 3D printing technology. Though cost-prohibitive at this stage, as the technology further evolves, 3D-printed implants will become a financially viable option, given the intensified competition among surgeons and improvements in the reimbursement plans.
Looking at the potential of these implants, manufacturers have been expending their efforts towards breaking big in the spine surgery landscape. A leading medical technology company, Xenco Medical, announced the launch of the first interactive vending machines for spine surgery instruments and implants, engineered by using highly durable composite polymer.
As robotic procedures are the future of the healthcare industry, the trends will be mirrored in spinal surgeries, particularly with the increasing demand for minimally invasive surgeries. The robo-guided spinal surgeries will aid in ensuring better patient outcome by helping surgeons place the implants accurately at pre-determined positions.
Ronak Shah is a market research writer at Future Market Insights.
Sabyasachi Ghosh heads the healthcare domain at Future Market Insights. The insights offered here are based on a study on Spinal Fusion Market