A Guide to Medical Device Contract Manufacturing
Medical device contract manufacturing is popular in various markets, including emergency room, home health care, critical care and industrial laboratories. Emergency room consists of medical devices for the labor, delivery and cardiac lab. Home health care devices include those that are used in a doctor's office while the critical care section involves medical devices for the respiratory therapy and operating rooms. These devices are often manufactured on contract basis, thus the name contract manufactured medical devices. These products often comprise very complicated bio-sensors, simple tubing sets and even ultra-precision devices made of plastics, metals, ceramics and electronics.
Companies involved in medical device contract manufacturing have clean room and non-clean room assembly as well as testing and packaging services for class I, II and III medical devices. Class I medical devices refer to products that are not harmful to the user. They even have very simple design compared to the other two devices. Class II devices often have special controls in order to make sure their safety and effectiveness along with the general control. For Class III devices, they require pre-market approval that will guarantee their safety and effectiveness.
Manufacturers who produce these devices on contract provide sterile and non-sterile products as well. Medical device Contract Assembly manufacturing involves assembly processes and capabilities that range from simple products, such as tubing sets to ultra-precision electro-mechanical devices. Most of them have to deal with manufacturing devices that are high volume disposable and low volume reusable. Also, they include a full service injection molding program, like the injection mold design, clean room injection molding and fabrication. The injection molding process uses machines that have very high costs while it is also difficult for the right mold to be designed. That is why most customers prefer to work with contract manufacturers for processes that requires injection molding.
Medical manufacturing are also offered with ethylene oxide and radiation sterilization coordination. This involves a wide range of possibilities, which gives extra care when it comes to the quality, responsiveness and efficient operation. These are the main features that you need to consider with regards to having an ideal medical device contract manufacturer. He should be able to closely work with the original companies who are into equipment manufacturing.
Medical devices that are manufactured in contract go through traditional, high quality contract manufacturing services. It helps to know that the process also provide automation design and building capabilities. If you want to make sure that your medical devices have the quality and efficiency at a reasonable price, you should go for medical device contract manufacturing rather than the other options available.