This winter, K2M Group Holdings, the first top spine company to market a 3D printed titanium interbody device, announced that it had entered into a comprehensive development agreement with 3D Systems; the two also set up a separate supply agreement for K2M’s CASCADIA TL Interbody System, which features its Lamellar 3D Titanium technology. Now, in an effort to meet the rising demand for adult spinal surgery, the companies are working together again to create 3D printed implants and virtual surgical plans for complex spinal operations, along with preparing for the development of other patient-specific spinal devices.
“K2M serves an example of how 3D printing technology is enabling a company like K2M to stand shoulder-to-shoulder and compete with industry giants,” Gautam Gupta, VP Business Development for 3D Systems, told 3DPrint.com. “K2M is using the technology to introduce new innovative products to the market at a very fast rate and thereby differentiating themselves from the rest of the industry.”
This new strategic partnership will combine the metal 3D printing experience of 3D Systems with the spinal expertise of K2M, building on the specific capabilities, and cultural values, of each company in order to increase innovation.
“We understand the spine and 3D Systems understands 3D printing, but there are a lot of synergies in the way we run our businesses, our dedication to innovation, our overall goals as organizations, and our mutual desire to make patients’ lives better,” said Jim Ham, Director of Marketing for K2M’s Complex Spine Group.
“We needed 3D printing capabilities to continue to develop our degenerative and minimally invasive portfolios, and 3D Systems gave us those capabilities. Our partnership with 3D Systems drove our leadership in 3D printing of spinal devices, which has vaulted us further into the broader spine space and accounted for a lot of our growth over the last few years.”
K2M uses 3D Systems’ precise direct metal printing (DMP) technology to 3D print its spinal devices, which are utilized by surgeons around the world to treat complicated spinal diseases.
Tim Van Cleynenbreugel, Director of Business Development for Healthcare at 3D Systems in Leuven, Belgium, said, “More than a decade of experience and 500,000 manufactured devices has shown us that direct metal printing using a laser beam is extremely well-suited to building spinal interbody fusion cages with porous structures and organic shapes.”
The company also provides 3D printing production and post-treatment of parts, as well as design consultancy, for K2M’s CASCADIA interbody systems. The CASCADIA products, including TL, AN, Lateral, AN Lordotic Oblique, and Cervical Interbody Systems, incorporate K2M’s Lamellar 3D Printed Titanium technology, which allows for bone integration through the device thanks to a porous structure and rough surfaces.
CASCADIA implants are made by selectively applying a high-energy laser beam to titanium powder, and would not be possible to make with conventional manufacturing methods. By adding 3D Systems’ production workflow to its CASCADIA systems, K2M can also take advantage of post-processing technologies, like surface finishing, cleaning, heat treatment, and laser marking.
Recently, K2M called on 3D Systems and its Virtual Surgical Planning (VSP) capabilities to make a compassionate use device, which is offered to patients in situations when there are no other good alternatives. K2M group project manager Sean Reynolds was discussing recent company developments with Dr. Michael Finn, a University of Colorado neurosurgeon whose specialty is spinal disorders. Dr. Finn thought that a 3D printed implant could help one of his patients who was suffering from limited mobility after an operation.
“There’s a lot of stress on that area of the body and the patient wasn’t healing well. I thought a 3D printed implant would give the patient the best chance to heal,” explained Dr. Finn.
Following a few web meetings with Dr. Finn and K2M and getting a look at the patient’s spinal scans, 3D Systems worked up a virtual surgical plan, including the implant design and type of screws. According to Dr. Finn, the operation and the partnership between 3D Systems and K2M were both successful.
“I was impressed with the dynamism of both companies. They really focused on getting something done in a timely fashion,” Dr. Finn said. “K2M knows how to come up with new innovations to support surgeons performing complex operations, and 3D Systems has participated in so many similar procedures in the past that it was a walk in the park for them.”
While compassionate use cases are not common, the collaborative process between K2M and 3D Systems could be a potential model for future development of patient-specific implants, which would be cleared by the FDA “to be manufactured within certain ranges based on the patient’s needs.”
Reynolds said, “Based on our experience with 3D printing, we believe that in the future 3D printed patient-specific spinal implants will be common for not only complex cases, but degenerative cases too. We’re very satisfied, encouraged and excited about the prospects for this and other types of collaboration with 3D Systems in the future.”
By working together to complete this successful operation, 3D Systems and K2M have found a potential new area of business in providing patient-specific implants and surgical planning for complex spinal degeneration cases.
You can read the full case study here.
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