Odyssey Medical Technologies: High-Precision Implants and Instruments with Tight Tolerances
Ken Birdsong, President & Managing Partner
As medical implants and instruments become increasingly complex with smaller configurations, precision becomes the most critical parameter in their manufacturing. No wonder medical device manufacturers (MDMs) are now more intent than ever on quality assurance—precise dimensions, tight tolerances, surface finishes, and validated processes and performance. This demands advanced machining equipment operated by skilled workers with extensive knowledge about material behavior as well as the intricacies and limits of the machines they operate. Critical dimensions that don’t meet specifications could negatively impact product performance and perhaps even harm patients. Tennessee-based Odyssey Medical Technology, with its expansive, state-of-the-art equipment and proficient employees well versed in CAD/CAM, 5-axis milling, Swiss-turn machines, along with electrical discharge machining (EDM), entirely fulfills the aforementioned criteria. It provides advanced manufacturing of medical devices for orthopedics, spine, trauma, reconstruction, and other extremities with complete in-house implant finishing capabilities.
An ISO 13485 certification, coupled with FDA registration for the manufacture of orthopedic implants and instruments, clearly validates Odyssey’s ability to deliver precision and tight tolerances. The company’s four- and five-axis milling capability enables unique part features with tight tolerances, especially in the case of cervical and inner body cages for the spine. From an implant standpoint related to turning, Odyssey effectively produces single, double, and quadruple-lead threaded screws with super finished head-bodies. “For the spine, we support standard reduction as well as minimally invasive spine surgery (MIS) with a proprietary finishing process that produces high-quality luster. Both the looks and performance of our products help our clients steer clear of their competitors,” adds Ken Birdsong, president and managing partner at Odyssey.
Odyssey has distinct and dedicated instrument and implant production areas—last year, it built focused factories for manufacturing these distinct medical devices. Starting from spinal component manufacturing and gradually expanding into various other medical sectors, the company has recently entered the sterile/non-sterile packaging space. “Inpatient procedures and surgeries are increasingly moving out of big hospitals and into ambulatory surgery centers (ASCs) in order to reduce costs, improving operational efficiencies, making patient access easy, and boosting physician engagement. This transition will naturally demand more and more single-use devices and pre-packaged sterile packs. While we capitalize on this opportunity, both our existing and emerging customers can benefit from our sterile/non-sterile packaging offerings,” says Birdsong.
As a contract manager, the solutions Odyssey provides vary with respect to distinct client problems. In the case of a client—producing external struts for external fixators—whose existing contract manufacturer had stopped that kind of production, Odyssey proved of great assistance. The company dissected the product structure and its manufacturing process, performed tedious assembly work, and produced pre-tested products for the client in merely four months. Odyssey now also has a stocking program for the client where the turnaround time for any order is just three to four weeks. “I believe, customers are increasingly looking for their contract manufacturers to oversee stocking and inventory management, or rather manage the entire supply chain. And that is where we are headed—to develop the ability to effectively manage the continuum of the product lifecycle, all the way from the origination of drawings and manufacturing processes to finished goods, customer logistics, as well as repair and reprocessing,” remarks Birdsong.
Over the past decade, Odyssey has developed comprehensive quality control systems (QMS) specific to the manufacture of medical implants while passing audits by FDA every two or three years without any exceptions—the recent one being conducted in August 2019. This utmost emphasis on quality has helped Odyssey grow its customer base from one to 30 over the five years since inception. The company now plans to integrate a new 12,000 square feet area into its existing 37,000 square feet facility to primarily enhance its sterile/ non-sterile packaging capabilities and later develop in-house sterilization too.
Management Ken Birdsong, President & Managing Partner
Description Odyssey Medical Technologies provides advanced manufacturing of medical devices for orthopedics, spine, trauma, reconstruction, and other extremities with complete in-house implant finishing capabilities. An ISO 13485 certification, coupled with FDA registration for the manufacture of orthopedic implants and instruments, validates Odyssey’s ability to deliver precision and tight tolerances. The company’s four- and five-axis milling capability enables unique part features with tight tolerances, especially in the case of cervical and inner body cages for the spine. From an implant standpoint related to turning, Odyssey effectively produces single, double, and quadruple-lead threaded screws with super finished head-bodies
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