Implantable-Device Contract Manufacturing
A vertically integrated contract manufacturer serving the medical device industry, Donatelle has expertise in producing implantable devices. The company can assist customers with product design and development; is experienced in molding, machining, and assembling custom devices; and offers packaging and sterilization management. ISO 9001:2008 and ISO 13485:2003 certified and FDA compliant, the service provider employs manufacturing processes that are validated according to 21 CFR Part 820 quality system regulations. The contractor’s service portfolio comprises design engineering, prototyping, rapid tooling, around-the-clock controlled-environment molding of engineered resins, and fabrication of close-tolerance, precision components employing milling, turning, and electrical-discharge machining.
NEW BRIGHTON, MN
Catheter and Guidewire Manufacturing Services
Representing a merger between ASG Medical Systems and Technical Innovations, Syneo integrates machines and systems that are employed for cutting, feeding, testing, assembling, drilling, punching, skiving, and printing catheters and guidewires. The company’s product integration and automation capabilities enable it to combine, modify, and optimize medical device manufacturers’ designs and meet their specific catheter and guidewire needs.
ASG Medical Systems
WEST PALM BEACH, FL
Diversified Plastics Inc. specializes in the injection molding of high-precision, close-tolerance, small- to medium-sized plastic medical device components. The company serves as a single source for manufacturing services, from design assistance and mold production to injection molding and assembly. Its tooling division produces molds for preproduction and small-scale runs and multicavity tools for full-scale production. The manufacturer also maintains an ISO Class 8 cleanroom reserved for assembly, sonic welding, and part-packaging operations. Its mold-making equipment is capable of creating complex mold designs, and its electric molding machines are suited for producing high-precision components from high-performance materials in a cleanroom environment. Parts can also be machined from plastic tube, rod, or bar stock for low-volume applications or when the material is difficult to mold.
Diversified Plastics Inc.
Cleanroom Molding Services
Spectrum Plastics Group, a molding services provider, has production facilities that are equipped with cleanroom areas for performing molding, assembly, and packaging operations under tightly controlled environmental conditions. The company maintains ISO Class 7 and ISO Class 8 zones at both of its production sites. It also offers full-service capabilities ranging from initial concept and rapid prototyping to quick-turnaround tooling and injection molding. In addition to the company’s ability to cleanroom mold implantable devices, minimally invasive surgical instruments, and other medical products, it is technologically equipped to perform micromolding. It can also prepare for and manage sterilization procedures.
Spectrum Plastics Group
A company that molds plastic components on a contract basis can overmold bondable liquid silicone rubber (LSR). Rogan Corp. injection-molds the bondable LSR directly to plastic or metal parts, integrating the silicone rubber with the plastic or metal in a single molded product that features an enhanced appearance and adds the performance characteristics of LSR to those of the substrate material. The benefits of bondable-LSR overmolding include integral shock and vibration protection, sound dampening, minimization of the number of components in an assembly, and simplified inventory management.