Selection of a Contract Manufacturer for Production Transfers or Line Duplications
Selecting the right CM (Contract Manufacturer) is critical for a successful medical device. Companies switch contract manufacturers for a variety of reasons, such as risk, quality, cost, and manufacturing scaling-up or continuation, but not many CMs can easily conduct production transfers and line duplications. With proper planning and strict adherence to best practices from your Contract Manufacturer, you can ensure that the transfer of your product assembly or line duplication is straightforward and stress free:
Compliance and Quality
Medical devices are designed to be used on patients to improve their lives, so it’s not surprising that the design, manufacturing, and marketing of medical devices is so highly regulated. High quality is a prerequisite when manufacturing medical devices. Legal manufacturers are required to produce their device under an established Quality Management System. Smooth transitions require a Contract Manufacturer who understands your needs and obligations, helps you ensure compliance with tight regulations and is always ready for notified body and customer audits.
Communication
Excellent communication from the onset is crucial to implementing a successful transfer or line duplication. In the planning stage, you will want to conduct a risk analysis to identify any potential issues and establish a transfer process for quick production. Consider a Contract Manufacturer that already has a product introduction plan (NPI process) in place, is willing to communicate openly, be responsive to your needs, and takes all the necessary steps to guarantee a seamless transition or line duplication.
Capacity
Transferring all the knowledge and complexities of your medical device to a new CM is a crucial step to the success of your product. The Contract Manufacturing team must understand your manufacturing processes and be fully committed. Look for a partner that offers engineering capabilities to optimize the manufacturing of your product, and optimum capacity to get your device faster to market.
Credibility
Of course, all contract manufacturers will promise a smooth transfer or line duplication process. Unfortunately, not all have the expertise and experience to guarantee an effortless transition. In this high-stakes market, nothing can replace the been-there, done-that know-how that only comes with decades of experience. While everyone needs to start somewhere, the best contract manufacturers have employees with years of industry experience. This helps to ensure production transfer or line duplication success by recognizing problems early and knowing exactly how to overcome them.
Why trust Valtronic as your partner for production transfers or line duplications
For over 35 years, Valtronic has developed the expertise and proven track record in transferring our partner’s existing medical device manufacturing into its facilities. Our dedicated full-service medical device contract manufacturing team will work as an extension of your own team while our world class methodology, checklists, and validation processes make sure nothing gets forgotten. Valtronic uses a careful approach to transfer products from the partner’s facility into one of our ISO 13485 certified and FDA Registered manufacturing facilities. Our global manufacturing footprint allows us to quickly adapt to your production needs, ensuring a smooth transfer process at the highest quality and lowest risk.
For more information on how to partner with Valtronic for line duplications or production transfers:.
