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In 2020, LimaCorporate (Lima) and Hospital for Special Surgery (HSS) are expected to begin operation of what is reported to be the first 3D printing facility to produce custom complex orthopedic implants in a hospital setting.
“The close integration between surgeons and engineers is invaluable for designing and refining joint replacements, and identifying new solutions for the most complex patient cases,” said Leonard Achan, Chief Innovation Officer at HSS, when the partnership was announced.
The facility will be operated by Lima and reside on the HSS main campus in New York City, and will combine Lima’s manufacturing experience with HSS’ clinical care and biomechanical engineering expertise. Patients will be scanned on-site at the new facility where their custom implant will be created in the lab.
The facility will initially serve hospitals in the region, with plans to make devices available to all providers in the U.S., allowing the facility to be accessible to all who need complex implants, not just HSS patients.
The HSS and Lima partnership began in 2016 when the two formed an Innovation Alliance Agreement, allowing HSS to source custom implants that leverage Lima’s proprietary Trabecular Titanium™ material and 3D printing technology. Now, by placing a design and printing facility on HSS’ campus, the partners expect to increase the availability and speed of personalized orthopedic care. Surely, numerous stakeholders in the orthopedic industry will watch to gauge the model’s success.
The pursuit of 3D printing in a hospital setting has increased in recent years. SME’s Medical Additive Manufacturing/3D Printing 2018 Annual Report noted that 16 of the top 20 hospitals as ranked by U.S. News and World Report have implemented a 3D printing strategy, primarily for pre-surgical planning purposes like anatomical models and cutting guides.
FDA is engaging with hospitals, industry and societies about point-of-care additive manufacturing scenarios, and working on guidance. This would spur more interest in the technology from hospitals and create more relationships like the Lima/HSS partnership, whereby hospitals work with seasoned manufacturers to produce devices.
At OMTEC® 2018, David Hwang, Ph.D., a Spinal Device Reviewer at FDA, said, “We’re working on a guidance document. As you can imagine, it’s a lot easier to speak on technical topics, and something as complicated as point-of-care printing has a lot more layers.”
Conversations at OMTEC 2019 also broached the practice of point-of-care manufacturing, with members of the additive panel saying that it could increase technology adoption, but the concept needs to be approached with caution.
“Kudos to FDA for seeing the reality of this technology and its enabling characteristics,” said Gordon Hunter, Ph.D., Principal Manager, Material Science, Smith+Nephew, who noted that FDA is soliciting input from industry and hospitals about how to move forward.
Comments from Gene Kulesha, Senior Director of Advanced Engineering at Onkos Surgical, summed up most of what we’ve heard from industry thus far.
“One of the biggest fears that we have as a manufacturer is what other people are intending to do with the technology, ” he said. “I am hoping that everyone exercises restraint and uses it in appropriate and low-risk applications.”
