Contract manufactured medical devices are widely used in a variety of markets such as critical care, emergency room, home health care and industrial laboratories. The critical care section includes medical devices for respiratory therapy and operating rooms. The emergency room includes the medical devices for the cardiac lab, labor and delivery. Medical devices used in home health care such as a doctor?s office and medical laboratories can also be manufactured on contract basis. Contract manufactured medical products usually include simple tubing sets, very complicated bio-sensors, and even ultra-precision devices made from plastics, metals, electronics and ceramics.
Medical device contract manufacturing companies offer clean room and non-clean room assembly, testing and packaging services for class I, class II and class III medical devices. Class I medical devices do not cause any harm to the user and are very simple in design, compared to the other two devices. In class II devices there are special controls to ensure safety and effectiveness in addition to the general control. Class III devices require pre-market approval to ensure device safety and effectiveness.
Medical device contract manufacturers also provide sterile and non-sterile products. The assembly processes and capabilities of medical device contract manufacturing range from simple products such as tubing sets to ultra precision electro-mechanical devices. Most contract manufacturers deal with high volume disposable and low volume reusable device manufacturing. They also have a full service injection molding program such as injection mold design, fabrication and clean room injection molding. The cost of machines for the injection molding process is high. The design of the right mold is also difficult. Hence most customers go for contract manufacturers for the injection molding processes.
Some medical device contract manufacturers offer ethylene oxide and radiation sterilization coordination. A wide range of process capabilities, giving more care towards the quality, responsiveness and efficient operation are the main features of an ideal medical device contract manufacturer.
Medical device contract manufacturers usually work closely with the original equipment manufacturing companies. The contract manufacturing of medical devices includes traditional, high quality contract manufacturing services. It also introduces automation design and building capabilities.