Founded in a Fairborn garage in 2013, Tangible Solutions manufactures American-made, 3D-printed titanium orthopedic implants for medical-device companies. The company has grown from two engineering-grade plastic printers to a 25,000-square-foot facility with more than three dozen pieces of capital equipment and nearly 50 staff, while producing over one million orthopedic implants. Its ISO 13485:2016-certified operation manages implant development and production from early design through finished medical devices.
ISO 13485:2016
FDA Registration #3014273501
Registration
Infinite Medical SolutionsBuilt on more than 40 years of experience, Infinite Medical Solutions manufactures precision orthopedic and trauma implants and manages their engineering, processing, and assembly in Eastlake, Ohio. Its 200,000-square-foot facility on 14 acres is set up to scale complex medical-device projects, from spinal implant assemblies to micro-machined suture buttons. The company’s quality systems comply with ISO 9001, ISO 13485, and AS9100, reflecting its roots in aerospace as well as medical manufacturing.EASTLAKE, OH
Invent MedicalFounded in 1991 in a garage by two brothers-in-law, Invent Medical develops and 3D-prints custom orthotic and prosthetic devices for clinics and hospitals. The independent, family-owned company has evolved from traditional plaster fabrication into a digital O&P operation, using workflows it has refined since adopting 3D printing in 2010. Invent Medical fabricates devices in the United States and operates across eight countries, serving more than 1,000 clinics and hospitals in 40 countries; its devices are developed with patient trials and produced under ISO 13485 certification.WARMINSTER, PA
ARCH Medical SolutionsARCH Medical Solutions brings together a nationwide network of FDA-registered facilities to contract-manufacture tight-tolerance medical implants, instruments, and components for OEMs. Its precision work spans orthopedic devices and surgical-robotics parts, with engineering support and prototype-through-production services built into the process. The company also develops MedTorque silicone-handled surgical instruments and operates under ISO 13485-certified quality systems.QUAKERTOWN, PA
Troy Innovative InstrumentsSince 1995, Middlefield, Ohio-based Troy Innovative Instruments has made precision-machined components and assemblies for medical, dental, defense and weapons applications. The company is particularly experienced with spinal implants and other tightly controlled medical components, while its integrated facility supports demanding defense and firearm work. Troy’s long-serving employees—including key shop-floor staff with more than 20 years at the company—work within ISO 13485- and ISO 9001-registered quality systems, with ITAR and FDA registration.MIDDLEFIELD, OH