Tsunami Medical, a pioneering provider of spinal implants, has begun operating an array of four GE Additive Concept Laser AM systems, two DMLM and two Mlab, at its facility in Modena, Italy.
Founded in 1997 in Modena, in Italy’s “Biomedical Valley”, Tsunami Medical began using AM as early as 2010 with selective laser melting (SLM) machines, to design and manufacture medical implants. As part of a forward-looking strategy to adopt AM into its innovation and production processes, Tsunami had purchased its first two Direct Metal Laser Melting (DMLM) machines in 2015, and has since led the way in AM-driven innovations in spinal cages and implant.
Spinal implants, in this case cages in combination with screws, basically support restoration for damaged spines by relieving pressure or providing corrective guidance for the spinal column in patients impacted by spinal stenosis or other degenerative diseases. Spinal cages, typically made of PEEK plastic or titanium, provide a minimally invasive solution to restore mobility and strength in the spine, and improve patient outcomes for those suffering from injury or degenerative diseases. Tsunami Medical specializes in these spinal implants, as well as other tools and instruments to support surgeons in delivering successful spinal surgeries.
Traditionally-made spinal implants have their disadvantages. Titanium implants (cage and screws) have much lower elasticity than bone, so their rigidity negatively impacts bone structure and restoration. PEEK implants, which are highly biocompatible, do have elasticity and properties similar to bone, and being plastic, do not cause any issues in medical imaging processes. Yet PEEK implants do not integrate well into the bone structure and tend to move from their intended positions in spinal implants.
By applying Concept Laser’s LaserCUSING process to its spinal implant applications, Tsunami Medical was able to address the limitations in titanium and PEEK. To do so, the company 3D prints complex geometries in titanium, featuring lattice, pores, or web-like structures to reduce density and provide similar elasticity to PEEK. Moreover, they can be customized to the individual patient’s anatomy. Since no additional coating or major post-processing is required, this can be done in one-production step. The company developed an innovative system—the Giglio Interspinous Fusion System—that develops ready-to-use implants directly from AM machines.
Stefano Caselli, CEO and founder at Tsunami Medical, explained the importance of AM in developing such innovative systems:
“[C]ollaboration and shared learning with medical and healthcare professionals around the world is invaluable. Their ideas and continued enthusiasm for metal additive energizes us and helps to influence and shape our innovation strategy going forward. DMLM helps us achieve the accuracy, complexity and functional integration we are striving for. It also delivers a great surface quality than reduces or sometimes eliminates the need for typical post-processing, which in turn drives productivity gains. The implant comes out of the machine with an optimized 20-unit printing cycle, without the need for support structures. It is already fully assembled and except for final polishing requires no post-processing. No other machine today would have been able to give us this kind of performance.”
The company has also innovated by developing novel self-spreading intervertebral spacers, “lobster spacers” (left-below), which uses a gear and screw mechanism to adjust spreadable wings, and by developing a disc prosthesis (right-below), which includes two shells connected by a double spring, as a single printed component.
Both innovations were enabled by Concept Laser’s LaserCUSING metal 3D printers, which provided the needed accuracy, surface quality, complexity, one-step production, and functional integration that only DMLM can provide. Not only can implants be customized to each individual patient, their structures can also be optimized and designed to deliver performance closer to that of actual bone. LaserCUSING also allows for the integration of highly-precise, small scale, functional assemblies as a single component, and for the on-demand production of parts that require very little post-processing.
Tsunami Medical has produced more than 50,000 components for customers worldwide using AM. Now, it has added two Concept Laser Mlab systems to its existing DMLM systems, expanding its fleet to four AM systems.
This is becoming increasingly common among medical device innovators, as the Mlab system allows researchers to have in-house control from design to development and even production of implants or devices, eliminating the need for outsourced services, and accelerating new product development, as well as commercialization. NexxtSpine, a US-based medical device company, has been using Mlab systems since 2017, and just added two more this year to its fleet of AM production systems. This indicates that there is a shift, within the orthopedic implant and device sector, from R&D and conceptual development to serial production, with an increase in production volumes, enabling innovators to expand into distribution and commercial, patient-ready, manufacturing.
Last year, SmarTech’s study, “Additive Manufacturing in Orthopedics Markets for 3D printed medical implants“, estimated that the total revenue generated by additive orthopedics in 2018 was $500M globally, with $1 billion of additive implants produced by OEMs and contract manufacturers. The study also indicated a decreasing trend in production costs for the average off-the-shelf additive implant from $500 to $300, and noted that “segments such as spinal implants are being propelled towards additive at a lightning pace, while the major areas of joint replacement in knees, hips, and shoulders, are progressing more steadily”, with AM’s penetration in the spinal implant segment as high as 5%. This is expected to grow rapidly in the coming years, with SmarTech estimating a 29% CAGR through 2026 for AM in orthopedic and medical implants.
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