Applied Rapid Technology (Fredericksburg, VA)
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.
Rotor Bearing Solutions International (Charlottesville, VA)
RBSI, which consists of experts having 30 plus years of cumulative experience, specializes in providing services related to rotordynamics analysis and design, fluid film bearing analysis and design, critical machine fix and failure analysis, API or ISO machine rotordynamic audits, active and passive rotor/magnetic bearing systems and rotor/bearing systems industry seminars. Their expertise also directly relates to active and passive magnetic bearing designs for rotary blood pumps.
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.
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.