Issue link: https://beckershealthcare.uberflip.com/i/1242960
22 Executive Briefing 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." n DeGen Medical, Inc. is a medical-device development company dedicated to providing surgeons with innovative products engineered to improve quality of life for patients with complex spinal disorders. World-class implants, coupled with intuitively designed instrumentation, provide a complete package to promote superior surgical outcomes. Our passion to advance spine-care solutions is driven by clinical insights, sound research, and science-based design. DeGen Medical maintains the highest quality standards to provide reliable products and safeguard patient health.