Tangible Solutions, a contract manufacturer of American-made 3D printed titanium orthopedic implants, is expanding its engineering and post-processing staff as well as equipment used in the post-processing side of the business. The company supports all phases of orthopedic implant creation through design, prototyping, pre-submission testing for 510(k) clearance, 3D printing, post-processing, and testing throughout and after production.
For instance, the ISO 13485:2016 certified and FDA registered company purchased and installed three new 3-axis milling machines for creating precise surface dimensions in post-processing of medical-grade implants and devices.
“Tangible Solutions offers orthopedic OEMs and clients two very distinct advantages,” stated Adam Clark, chief executive officer of Tangible Solutions in a news release. “Our business model focuses 100% on 3D printed titanium implants for the orthopedic industry. That’s all we do, so we are experts in the entire product development lifecycle and how to best support our customers.
“Secondly, we handle the entire process of additive manufacturing these devices in house," Clark added. "We know the FDA submission and clearance process inside and out. All post-processing is done in house, and we know and understand how vital it is that medical devices be beyond clean and biocompatible. They must be unbelievably smooth to avoid patient irritation. Our knowledge controls the testing, the inspections, and meets the most rigorous standards.”
Tangible is also expanding the types of devices it produces. “Tangible is widening out into devices for the extremities and total joint replacement in addition to the spine,” stated Chris Collins, chief operating officer and Tangible co-founder. “We are manufacturing 3D printed parts for the knee, hip, foot, and ankle. Several of our Tangible team members have extensive experience in the Orthopedic resurfacing space including the Director of Sales & Marketing with 29 years of experience in TKA and THA.
"The orthopedic industry is becoming more creative and thinking outside the box, realizing that a 3D printed implant can be so much more than a flat, solid plate. The power of additive manufacturing is that it provides features such as custom rough surfaces and lattice structures that are tuned to loading conditions for topology optimization,” he added.