3D Printed Spinal Implants for the Medical Device Market
As we’ve written before, the problem with investing in emerging technologies is that you can rarely predict which industries will be disrupted and which will remain completely unaffected. 3D printing has certainly been among the most unpredictable technologies we cover. Real growth is coming in areas like distributed manufacturing, led by companies like Materialise (MTL), and 3D metal printing from new growth stocks such as Desktop Metal (DM). Meanwhile, healthcare remains a niche market, with the most common use case to date being dentistry for people to straighten their ogreish smiles at home using 3D printed aligners from companies like Align and SmileDirectClub (SDC). The real growth area is expected to be for medical devices, including anatomical models to guide surgeons, personal prosthetics, and customized implants. Today we want to talk about the potential for 3D printed spinal implants.
The Case for 3D Printed Spinal Implants
About 1.6 million instrumented spinal procedures are performed each year, according to iData Research, which says the market is somewhere around $6 billion. While we normally don’t put too much faith in random market reports, iData Research has been around for about 15 years and specializes in medical device market research. The firm even provides some transparency into its methodology, so we’ll give it the benefit of the doubt. A few things to note about these numbers. There are multiple categories for spinal procedures, which may be categorized by the region of the spine or implant type, ranging from plates to screws to interbody fusion devices. All that hardware sounds kind of painful.
The market numbers themselves remain pretty steady, with little actual growth year to year. More generally, Gartner projects that commercialization of 3D printed medical devices will mature pretty rapidly compared to other markets:
3D printing for surgical applications only really began earlier this century, and use in spine surgery is especially new, according to recent research paper on the topic of 3D printing in spine surgery. The most common application, as we alluded to earlier, is to create 3D-printed models for things like preoperative planning and patient-specific surgical guides. But the 2019 paper goes on to report:
However, the ability of 3D printed implants to effectively address variations in anatomy, size, bone quality and pathology in the population is now beginning to be appreciated. Expanding techniques in spine surgery require uniquely shaped implants and materials that are biocompatible.Some Really Big Brains
In other words, off-the-shelf spinal implants are good enough for many cases but not all. 3D-printed spinal implants can address extreme cases such as congenital deformity or destruction of the spine from a tumor. On the flip side, costs and availability will probably remain a deterrent in the near-term until the technology becomes more widespread and accepted.
Certainly, we’re seeing adoption of 3D printing technology among some of the major medical device manufacturers. One that immediately comes to mind is Stryker (SYK) and its 2018 acquisition of K2M, giving the company the world’s largest additive manufacturing facility for orthopaedic titanium implants. Even more relevant is the acquisition by Johnson & Johnson (JNJ) of Emerging Implant Technologies (EIT), a private German company that manufactures 3D-printed titanium interbody implants for spinal fusion surgery. EIT has developed a proprietary cellular titanium technology with an open and interconnected porous structure (think lattice) designed to allow bone to grow into the implant. The 2018 acquisition bought J&J a 3D-printed spinal implant technology cleared for use by the Food and Drug Administration (FDA).
However, not every private 3D printing medical device company has sold out yet.
A Couple of 3D Printed Spinal Implant Companies
Claiming to be the largest privately held company for spinal fusion solutions, Centinel Spine began operations in 2008 out of Pennsylvania following the merger-acquisition between two medical device companies — Raymedica and Surgicraft. The company took its first venture capital just last year, a $40.5 million round, which it promptly handed over to golf superstar Tiger Woods, who serves as the company spokesperson. It has a range of products focused on anterior spinal column reconstruction. In 2018, the company went 3D with its FLX technology platform of 3D-printed porous-titanium interbody devices.
The design sounds similar to the tech acquired by J&J in the EIT deal:
FLX implants are 3D-printed porous titanium implants that have been meticulously engineered, down to the cellular unit level, to mimic bone. These implants boast … [a] lattice with a structure and modulus of elasticity similar to bone, and have optimized mechanical, visual, and osteophilic environments that reduce stress shielding, enable fusion assessment, and support bony in-growth, on-growth, and thru-growth.
At the end of 2020, the company announced it has successfully performed 3,500 3D-printed spinal implants using the FLX platform.
Another privately held medical device company, Dallas-based Osseus Fusion Systems, has developed a line of 3D-printed spinal implants called Aries. Like the FLX platform, the porous titanium implants use 3D printing to create “shapes and structures that could never be achieved with traditional manufacturing.” The medical devices sport a three-dimensional, interconnected lattice network that mimics bone matrix, making it easier for the surrounding bones to graft onto the implant:
Osseus reportedly prints Aries interbodies on an FDA-validated selective laser melting 3D printer by sintering titanium particles into a solid shape. Its original Aries-L implant won FDA approval back in 2017.
We’ve often mused how, one day, artificial intelligence will become so ubiquitous that we will no longer focus on the technology itself but all of the amazing ways it is being applied throughout our lives. Ditto for 3D printing. We’re already seeing how manufacturers are adopting 3D printing technologies as part of a broader menu of services to their clients. Some jobs may call for injection molding while others require the customized precision of 3D printing.
The same would be true for 3D-printed spinal implants, where they will be offered as part of a greater portfolio of 3D-printed medical devices. In another decade or two, a hospital will simply print an implant on demand just prior to surgery. We doubt there will ever be a pure-play stock for 3D-printed spinal implants, but then again, someone thought it would be a good idea to invest in a company whose sole business model is 3D printing aligners for people with crooked teeth. The better bet is that companies like Stryker and J&J will dominate, especially now that we’ve seen elective surgeries like spinal procedures can be quickly upended, along with more than one small company’s fragile fortunes.
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