Electronic Contract Manufacturing for Medical Devices Industry
While provisions of electronic manufacturing services may vary from one manufacturer to another and each contract manufacturer may differentiate itself with certain special offerings, it is reasonable to expect a few key traits from any reputable electronic contract manufacturer. Below are 5 typical traits you would see in a quality contract manufacturer for medical devices.
Today, most medical device OEM manufacturers are requiring their contract manufacturers to attain ISO 13485 certification.
1. Experienced and Stable Managerial and Technical Team
A company with an experienced managerial, technical, and manufacturing team that has a wealth of knowledge is crucial for your manufacturing needs. The more experienced a manufacturer is, the more hands-on they can be with new projects. Experienced manufacturing engineers are often able to quickly identify and offer alternate solutions when problems arise based on previous projects. They can help with "design-for-manufacture" review, allowing OEM's to save time and money on assembly.
2. Tooling and Equipment
Tooling is what defines a machine shop’s capabilities as well as their limits. Having the machines and tools maintained properly is vital to producing quality products. Proper calibration of machines and tools should be performed in intervals, either designated by the machine's manual or by the product's specs, assuring the delivery of on-time high-quality products. A contract manufacturer is only as good as their equipment and their technical team. It is important to have the correct equipment and technology to create your products.
3. Maintained Quality Equipment to Achieve Tight Tolerance
Tolerance is the clearance range in size a component needs to be within in order to fit into another component. Being within the required tolerance is very important. More and more industrial applications require increasingly tighter tolerances. The medical industry is known for its stringent tolerance requirements, which are imposed on to its electronic contract manufacturer.
4. Agility and Being Able to Respond to Customers’ Demand Changes
Quality contract manufacturers deliver manufactured goods on schedule, as was agreed. Nothing is more frustrating than a missed product delivery. It is absolutely essential that the contract manufacturer you choose to work with is agile, flexible and highly responsive to your demand changes. If you are looking to save time and money, a manufacturer that offers both primary (for example, engineering design and tooling development) and secondary services (for example, power coating, sub-assembly, etc.) in-house is critical. This eliminates the shifting of your product from one manufacturer to the other, dismissing room for error, time lapses and extra cost on shipping and handling.
5. ISO 13485 Quality Management System
ISO 13485 Quality Management System is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. Based on the ISO 9001 process model concepts of Plan-Do-Check-Act (PDCA), ISO 13485 is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.
ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives OEM customers confidence in its ability to bring safe and effective products to market. It helps the electronics contract manufacturer to manage risk effectively and gain competitive advantage.
Today, most medical device OEM manufacturers are requiring their contract manufacturers to attain ISO 13485 certification.
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