Most companies that produce medical devices do not complete the prototype development or the manufacturing of the product once it is approved and in production. There are many reasons why this occurs, but the most common are the cost of maintaining the equipment, employees and in-house technology that is required for this very exacting process.
Increasingly Complex
Additionally, and one factor that is becoming more critical when in-house manufacturing is compared to contract manufacturing, is the complexity of devices. With more advanced design and production needs, using specialized medical device contract manufacturers provides the complex manufacturing requirements at a negotiated price.
Key Factors
However, it is important not to choose just any medical device contract manufacturers. Instead, look for a company that is experienced and has expertise in the general type of device. This is important for the following reasons:
Complete services from prototype development through to production. Some companies only offer prototype development, while others only offer large scale production.
Device design support from medical device contract manufacturers can help to improve on the device, enhance production, decrease costs and even extend the life cycle of the device with small but essential changes.
Understanding of the integration of various systems within the device. The more experience the medical device contract manufacturer has, the more they are able to provide the services you need within their own facility or with already vetted and trusted suppliers and service providers in their network.
In addition, an experienced manufacturer in the medical device industry has expertise in the complexities and requirements for validation and documentation throughout the process. As this is essential in device approval, working with a company that isn’t trying to learn these requirements but is comfortable and familiar with the practices can make all the difference in first approval rather than multiple attempts.
