When a company chooses to engage in medical device contract manufacturing, in many cases they are selecting this option to remain competitive in the medical device industry, which can be difficult because of price pressure. That’s why, to help save on cost, a number of corporations turn to Asia to outsource the production of their products.
While there is nothing wrong with medical device contract manufacturing overseas, it is essential that the companies who partake in these services make sure that they are choosing the right partner that will not only manufacture the best product but that will also follow necessary quality standards. For instance, typically a good contract manufacturing business will:
- Provide services, such as product prototype; plastic injection molding; production mold; compression molding; liquid silicone injection molding; ultrasonic, heat and high frequency welding; assembly, testing and packaging, as well as other auxiliary services, for example, metal machining.
- Manufacture devices in a controlled cleanroom environment.
- Have a quality system in place for medical devices, such as ISO and FDA and also have regulatory knowledge.
Each of the above factors is crucial and ensures proper quality, safety and effective results for all involved. In addition, good communication and understanding is integral to the success of any overseas medical device contract manufacturing partnership and project.
