The production transfer process for a medical device is necessary when a single-source supplier can’t perform tooling, molding, assembly, or complete contract manufacturing services. This blog explains the manufacturing product transfer process for medical devices and provides factors to ensure a successful transfer.
In today’s medical device market, there are several reasons for medical device OEMs to consider a production transfer for the manufacturing or assembly of a medical device from their site to another:
- To boost capacity
- To optimize costs
- To improve capabilities
- To relocate services closer to customers or component suppliers
The manufacturing transfer of medical devices is successful when it’s planned and executed properly. Below are five tips for a successful medical device transfer process:
Before beginning the production transfer process, ensure the supplier can meet your deadlines and compliance requirements, especially if you’re already experiencing timeline delays.
If you’re working with a single-source manufacturer but need to initiate the production transfer of your device to another supplier, make sure to involve your manufacturer from the start of the transfer process.
The medical device production transfer should happen throughout your device’s development process. Waiting until the end of the manufacturing process can result in delayed verification and validation activities.
Lastly, build the design transfer into your controls and implement them into your checklist. Once your design transfer activities are complete, you and your manufacturer should review your device for quality assurance to verify that it’s ready for full production.
The next tip for your device’s successful manufacturing product transfer process is to develop and use a production transfer checklist. The transfer process requires completing a Device Master Record (DMR), which includes a wide range of documentation like product drawings, process validations, manufacturing and inspection instructions, and training materials. Creating and using a transfer checklist ensures nothing is missed during the process.
With the right medical device manufacturing steps, you can streamline your medical device’s time to market date.
Below are some factors to consider when securing a successful product changeover procedure for your medical device:
Be sure to utilize experienced project managers and tools aligned with the defined project governance and model procedures. Your manufacturer should also support you throughout your regulatory submission process.
Next, you can help your manufacturer and device supplier develop an effective partnership by defining clear roles and responsibilities, inspiring motivation, and holding them accountable for completing specific project tasks.
Then, follow a standardized production transfer process by assessing the original product’s DMR and resolving any gaps by developing a detailed project plan that outlines all transfer activities.
The final factor to consider is to assess the production transfer risks and develop a plan to communicate them to key stakeholders, ensuring that the project is completed on time and without disruption.
At Remington Medical, we offer complete contract manufacturing services for medical devices, holding ourselves responsible for every step of the process from start to finish. But when you need a production transfer for your device, we partner with the best in the industry to ensure a streamlined process and quality product. One example of working with other suppliers to develop a high-quality medical device is evident in our customer relationship with Brijjit Medical.
Our team helped Brijjit develop a custom medical device manufacturing process for their force-modulating tissue bridge device. Once we defined a custom manufacturing process for the device and started production, a problem arose when the product’s material failed. Our team worked with Brijjit and a material supplier to help choose an alternative material. Then, we ran a small production with the new material to ensure it functioned correctly.
Contact us today to learn more about how we provide you with a streamlined process for manufacturing medical devices.
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