LimaCorporate (Lima) and the Hospital for Special Surgery (HSS) will co-found what is reported to be the first additive manufacturing 3D printing facility for custom complex orthopaedic implants in a hospital setting.
Operations are expected to begin by early 2020.
“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,” Leonard Achan, Chief Innovation Officer at HSS, said in a press release.
The facility will be operated by Lima and reside on the HSS main campus in New York, New York, and will combine Lima’s manufacturing experience with HSS’ clinical care and biomechanical engineering expertise. It will initially serve hospitals in the region, with plans to make devices available to all providers in the U.S., and will be accessible to all who need complex implants (not just HSS patients).
HSS and Lima are familiar partners—the two entities formed an Innovation Alliance Agreement early in 2016, allowing HSS to source custom implants that leverage Lima’s proprietary Trabecular Titanium™ material and 3D printing technology.
The concept of additively manufacturing implants in a hospital setting was discussed at OMTEC® last June. In an OEM panel on the implementation and advancement of additive, Michele Pressacco, Dr.-Ing., Research & Development Director of Lima, stated, “there is a big trend to personalize medicine…having the ability to delocalize the [additive] machine dramatically changes the business model. Having these machines located at the hospital would be a major change.”
A regulatory-focused panel at OMTEC also discussed point-of-care manufacturing in hospitals. One topic was whether or not FDA would publish guidance or regulations for manufacturing implants in a hospital setting. “We’re working on that type of guidance document,” explained panelist David Hwang, Ph.D., a Spinal Device Reviewer at FDA. “Something as complicated as point-of care-printing has [several] layers to go through.”
Hwang questioned whether hospital administrators, in efforts to cut costs, have taken into account quality considerations in point-of-care manufacturing. The newly announced collaboration is a logical step that answers those concerns. While the facility is located on the HSS campus, Lima is the registered manufacturer responsible for oversight.