Becker's Spine Review

21 Executive Briefing Sponsored by: A dditive 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 A new path: How one company aims to advance the next industrial revolution for medical devices

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