Additive manufacturing has been hailed as the next industrial revolution for medical devices. It’s a means of production well suited for rapid prototyping and complex, personalized designs. Grand View Research in 2019 reported an estimated annual growth rate of 20.8 percent from 2018-2026.
Since its genesis nearly four decades ago, additive manufacturing has made significant headway in orthopedics. In 2014 alone, around 25 orthopedic products manufactured via additive manufacturing received FDA 510(k) clearance, OrthoStreams reported. As of late 2019, the agency had reviewed more than 100 devices made and brought to market using 3D printers.
Spine in particular is moving toward adoption at a “lightning pace,” according to SmarTech Analysis; additive manufacturing accounted for an estimated 5 percent of the spinal implant segment in 2019.
Most companies bringing additive spine devices to market follow similar well-established processes, wanting to avoid the risks and expenses of charting a new path, according to Craig Black, president and CEO of DeGen Medical.
These deep-rooted additive processes for today’s spinal implants involve a series of extensive post-processing steps. Naturally, the more steps, the more opportunity for complications to arise, Mr. Black said.
For instance, the quality of a device can be affected simply by how it’s taken off the build plate. Then, when that device is transferred to a machine with cutting fluids or oils, the manufacturer must take steps to ensure those fluids get cleaned off.
Additionally, variation in the heat-treatment stage makes it especially difficult to ensure product consistency. Even a slight deviation could make implant parts brittle.
“Let’s say, for instance, that you changed a parameter on your laser in terms of how much power or temperature you were putting into a part,” Mr. Black said. “That could completely change the complexity of that part so it would perform completely differently. Now it may have subsurface porosity which is a huge problem — you basically have parts that are not fully dense, and they can fail.”
Mr. Black is intimately familiar with the complex, multistep additive manufacturing practices used by most companies today because DeGen Medical used to be one of them.
“As a result of going through the normal pathway and being frustrated, we decided there is a different way we can do this,” he said. “That’s what led us to this new process and this new material.”
Mr. Black wasn’t at liberty to share certain details about his company’s novel process and materials with Becker’s Spine Review; the company hasn’t yet submitted for FDA approval. However, it expects to make its suite of products commercially available later this year, along with specifics about how they’re made.
So, with a market debut in the pipeline, Mr. Black explained why he’s confident in DeGen Medical’s approach to manufacturing and what it could mean for the rest of the additive manufacturing industry.
The pathway less traveled
For many spinal implant companies, it makes sense to leverage the specialized expertise of original equipment manufacturers. OEMs play a major role in the worldwide additive orthopedics market, and together with contract manufacturers, they produced more than $1 billion worth of additive implants in 2019, SmarTech Analysis reported.
However, outsourcing places a significant amount of risk in an OEM’s hands, leaving device companies to simply trust that there won’t be any issues during the complex process, according to Mr. Black.
“When you don’t control the process, you don’t truly understand what your risk factors are,” he said. “When you let someone else do it and you don’t know necessarily what their laser parameters are, and there are some things they’re not sharing with
you, you yourself have not necessarily done all the research and development.”
That’s one reason why DeGen Medical chose to bring its additive manufacturing processes in house — and hired a team of engineers and scientists to make it happen. Relying on an OEM would have also limited the design of DeGen Medical’s devices, as well as the amount of research the company would have in its wheelhouse, Mr. Black said. To develop and control the entire process, DeGen Medical entered a strategic partnership with Linear Precision, a medical device company focused on 3D-printed implants. The two companies combined their resources with the goal of becoming the standard for additive manufactured spinal implants.
Of course, bringing manufacturing processes in-house wasn’t easy. The powder that DeGen Medical now uses to make its spinal products wasn’t available before the company developed its own specifications. This process meant going to the suppliers and having the material specially produced.
It was a lot of leg work, a lot of risk, and a lot of money — all things DeGen Medical was willing to put forth in exchange for a process that was faster, more replicable, and above all, safer.
Process-agnostic considerations for spinal implants
Safety should be the No. 1 priority for surgeons selecting a spinal implant under any circumstance, according to Mr. Black. Additional factors that should be considered — regardless of what additive manufacturing processes a device goes through — include whether the device helps promote fusion or creates subsidence.
The traditional additive manufacturing route doesn’t make a device less likely to satisfy these important criteria, Mr. Black noted; products following established pathways have been successfully used in thousands upon thousands of procedures with no issues.
What’s different about DeGen Medical is it can create devices that are just as safe, but it can do so with more speed, efficiency and replicability. DeGen Medical’s process can also help device makers avoid “exorbitant” costs that plague the industry today, while facilitating a higher degree of implant customization, according to Mr. Black.
By upending the traditional means of production with a safe and highly reproducible alternative, DeGen Medical hopes to elevate the entire 3D printing industry, which Statista expects will exceed $40 billion in market value by 2024. With SmarTech analysts predicting a “major shift” away from design and production methods based on machining, casting and coatings in favor of additive manufacturing methods — it’s an area ripe for advancement.
The road ahead for additive manufacturing
Once surgeons and other industry players come to understand DeGen Medical’s manufacturing approach, Mr. Black said it could become the standard that replaces traditional methods.
“They’re going to want to demand this process because it is more efficient, it is more reproducible,” he said. “Just as important, the process also means the implant costs are less expensive. That’s the market force that will cause people to at least look at it.”
Down the line, if other companies adopt DeGen’s Medical’s approach to additive manufacturing, they will likely have to resubmit all products made via that process for FDA approval. That’s the biggest uphill battle, according to Mr. Black.
But at the end of the day, he said, the advantages of a faster, more replicable process make it worth the challenge — and the global healthcare additive manufacturing market, which climbed to a market value of $951.2 million in 2018, will benefit.
“I feel like [other companies] aren’t doing the research and development to find safer, more efficient ways to advance the 3D-printing world,” Mr. Black said. “But that’s what we’re doing, every day.”
This article was created in partnership with DeGen Medical.