Applied Rapid Technology (ART) Corporation has been designing and creating prototypes for more than a decade. ART has the capabilities to assist engineers, designers, companies, and inventors transform their ideas into reality. As a rapid prototyping service, they function much like a machine shop, designing and fabricating parts for a variety of client needs. They specialize in plastics; using cutting-edge “additive manufacturing� processes to build customer prototypes. ART uses cutting-edge Stereolithography and Polyjet™ printing technologies for manufacturing. They have served clients from the medical, aerospace, consumer electronics, sporting goods and military industries. Since 2008, ART has worked closely with Dr. Throckmorton in the manufacturing of blood pump prototypes for her research program.
Cardiac Assist Incorporated (Pittsburgh, PA)CardiacAssist, Inc (CAI) is a Pittsburgh, Pa based medical device company that develops, manufactures and markets cardiac assist devices. The company was formed in 1996 by Dr. George Magovern, Sr. and a group of private investors to commercialize an implantable VAD. In 1998, the Company licensed key patents for a Percutaneous Transseptal Left Atrial Cannulation System, and subsequently made a strategic shift in direction toward the development of a short-term percutaneous circulatory support system. The relationship between ASRI/AGH and CAI continues to be strong with over 50 animal implants having been performed in support of FDA approval and commercialization of the TandemHeart. CAI currently has 42 employees, 30 in Pittsburgh and 12 in the field (sales and clinical training). CAI’s Quality System has been certified by TUV Product Services to meet ISO 9001 and ISO 13485. The TandemHeart™ pVAD, Controller, and Atrial Drainage Cannula bear the CE mark in recognition of meeting the Essential Requirements of the European Union’s Medical Device Directive. In the U.S., the pump, controller, and cannula are FDA approved and have been used in over 1700 cases. CAI has approximately 16,000 ft2 of leased space. The space includes Class 10,000 clean rooms for the assembly and packaging of sterile products, labs for the testing and development of product (both electronic and pump/cannula), a service/production area for controller assembly, repair and testing, a lab for quality control testing and analysis, and an environmental chamber for accelerated testing. Additionally, sufficient space is available for shipping/receiving, biohazard containment for returned product, and offices for management, finance, regulatory, service, clinical, marketing, quality, materials, production, information technology, and engineering.
Toxikon Corporation (Bedford, MA)Toxikon Corporation, a life science company, has thirty years of experience conducting compliance studies for product safety. It operates a 125,000 sq. ft. state-of-the-art facility in safety testing and research following Good Laboratory Practices (GLP). These studies are performed in support of U.S. FDA and other international regulatory compliance for products developed from the medical device, biotech, and pharmaceutical industries. Their safety services include a complete study range of hematology, toxicology, genetic toxicology, pharmacokinetics (PK), toxicokinetics (TK), bioavailability, extensive chemical characterization, impurities analysis and synthesis, and microbiology.
ThreeD Design and Manufacturing, LLC (Richmond, VA)3D Design is a manufacturing company in Powhatan County, Virginia with a close proximity to Virginia Commonwealth University. This company has the technical, mechanical engineering and manufacturing expertise with experience exceeding 30 years. It is committed to building productive partnerships that add value to the industrial, scientific and medical community. They have skilled engineers and technicians to execute design-build projects and prototype manufacturing at all levels. Their manufacturing floor capacity includes manual and computer numerical control (CNS) milling (20 inches x 40 inches), CNC turning (up to 21 inches diameter, 60 inches long), surface grinding (12 inches x 36 inches), outer diameter grinding (12 inch diameter, 36 inches long), and welding (all types and certifications). This company also provides services for rapid prototyping, electrodischarge machining, water jet shaping, laser cutting, sheet metal fabrication, plating of all types, and heat treating. Their customer base ranges from large chemical specialty companies and automated systems divisions and rotating machinery to scientific researchers at VCU.
Aircom Manufacturing Incorporated
(Indianapolis, IN)
Aircom Manufacturing Incorporated is a contract manufacturer with more than four decades of experience focused on the development, production and support of medical science industries. In addition to core competencies in chemical, automotive, and telecommunication industries, we design and build diagnostic meters and equipment, laboratory instrumentation, therapeutic devices, plastic disposables, and controls requiring hardware, software and embedded code. We offer product design, prototyping, tooling, injection molding, sheet metal stamping and fabrication, assembly, complete packaging and distribution. We have GMP-compliant engineering and manufacturing processes in place for the final assembly, testing and packaging of medical products.
Windings Incorporated (New Ulm, MN)
Windings, Inc. has over 40 years of experience in building components for electromagnetic/motion conversion applications. We have produced and supplied critical components to manufacturers working in the fields of motion control, medicine, avionics, aerospace, defense, power generation and automotive. Our experience is a valuable resource you can utilize to overcome production issues, reduce development time and minimize cost.