Surgeons in China performed the first spinal disc replacement implanting a three-dimensional printed vertebra, according to a CNTV report.
The 3D printing technology uses digital models of a patient's anatomy to construct a "printed" customized implant in almost any material. While the overall 3D printing technology isn't new, applying it to the orthopedic device space is cutting-edge and advances could make it more available to the general public. This could be disruptive in the traditional orthopedic and spine device markets, and become a game-changers in the clinical quality and cost-effective aspects of care.
Customization is a top priority in orthopedics; companies like ConforMIS built their entire technology platform on manufacturing implants based on three-dimensional images while other companies are increasing the number of sizes available in particular products. When implants fit patients better, they are able to recover more quickly and are less likely to experience complications or revision procedures. This saves significant time and money, and the patients are happier.
The 3D printing market for healthcare will generate more than $4 billion by 2018, according to a Visiongain analysis reported in Information Week. The 3D-printed medical models could also reduce surgical time, which is significant when average surgery costs $100 per minute.
This first spinal procedure using a 3D-printed vertebra replaced the second vertebra in a 12-year-old boy's neck. The boy had cancer, which was discovered after a traumatic soccer injury. After the procedure, the patient's head was framed with pins and will remain that way for three months. The surgeon who performed the procedure — Dr. Liu Zhongjun — said the customized 3D printing technology made the disc replacement stronger and more convenient than other procedures.
The surgeons are currently calling the spine surgery a success.
In June, French spine surgeon Vincent Fiere, MD, performed the first spine surgery using spine device company Medicrea's customized spine cages created with a 3D printer. The company's UNiD ALIF customized cage is made with polyetherketoneketone and printed to reproduce the anatomical details of the patient's vertebral plates. When the procedure was performed, the 3D printing technology and applications were patent-pending.
"Continuing our trajectory since the launch of our PASS LP UNiD rods which are made to measure for each patient, Medicrea confirms its position as the pioneer of intelligent spinal implants, perfectly adapted to the morphology of each patient's spinal column and developed in rational and planned manner to restore the fundamental mechanical equilibrium of the human body," said President and CEO Denys Sournac. "By providing pre-planned customization, our goal is to improve patient outcomes and allow our surgeon customers to complete their plans in advance and solely focus on executing their strategy in the OR."
Printable implants are also invading the orthopedics device market. The New Economy Magazine recognized Oxford Performance Materials as the best 3D healthcare innovations company for developing an additive manufacturing technique with ultra-high performance PEKK to print patient-specific functional and biocompatible prosthetic implants. The FDA cleared OPM's OsteoFAB Patient-Specific Cranial Device in 2013, which is a potentially disruptive device.
"What is exciting about our technology is that additional complexity does not necessarily increase manufacturing cost," said OPM Biomedical President Severine Zygmont. "As a result, we believe that additive manufacturing has the potential to not only improve patient outcomes, but fundamentally provide improved healthcare in orthopedics on a global scale — for developed countries and developing countries. These are disruptive changes that will allow the industry to provide healthcare at a lower cost."
Bigger medical device companies are also getting into the game. Johnson & Johnson's DePuy Synthes recently partnered with Tissue Regeneration Systems to develop 3D printing technologies as part of J&J's long-term strategy to grow the company. The partners are working on resorbable implants for the large bone segmental defect treatment in trauma and orthopedic oncology. Tissue Regeneration Systems has an FDA-approved bioresorbable skeleton reconstruction implant designed to fix burr holes made by neurosurgery without requiring metal screws for attachment. DePuy Synthes will add expertise in the orthopedic trauma development arena.
Johnson & Johnson is also putting more funding behind research and development collaborations after investing nearly $1.8 billion in research and development last year.
In a healthcare market prizing quality outcomes for lower costs, technology such as computer navigation comes at a high price whereas 3D printing could become a relatively economical investment. If hospitals and surgeons decide clinical advantages are enough to adopt the technology, it could be disastrous for traditional device companies without a 3D printing platform.
But don't look for a 3D spine device printer at the hospital near you quite yet. Most hospitals don't have the technology, and it would take staffing and philosophy changes to really implement this type of technology. Even advancements with the most promising clinical outcomes take years to really become the standard of care; spine surgeons are careful to show true benefits in the literature before adopting new technology and clinical studies take years. Even after the data is readily available, it's an uphill battle to gain regulatory clearance and payer coverage.
Three-dimensional printing has the potential to completely change the spinal implant market, but in the foreseeable future the tried-and-true implants and techniques will remain in most operating rooms.
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