The Medical Device Production Transfer Process

A production transfer is a common occurrence in the medical device industry. However, what often makes it necessary is a negative circumstance where something was discovered that needs to be fixed. In such cases, the transfer process is seen as the solution to address the issue and ensure business continuity. As a medical device contract manufacturer, we understand the importance of a successful transfer process and the confidence it can give to our customers. In this article, we’ll detail the steps we take to make a production transfer successful and give our customers the confidence they need to transfer their projects from a previous contract manufacturer.

The 5 Main Causes for a Medical Device Production Transfer

Before we delve into the specifics of Quasar’s production transfer services, let’s understand the common motivating forces behind OEMs deciding to transfer their production to a new contract manufacturer:.

Boost production capacity

As demand for their products increases, OEMs may need to find a manufacturer with the resources and expertise to increase production volumes to meet customer needs.

Optimize costs

OEMs may be seeking a contract manufacturer that can offer more competitive pricing, which can help them increase profit margins or reduce costs for their customers.  

Improve capabilities

OEMs may transfer their projects to a contract manufacturer with better capabilities, such as advanced technologies or more efficient manufacturing processes, which can help improve product quality and reduce time to market.  

Mitigate risk

By diversifying their supply chain sources, OEMs can help mitigate risk and ensure business continuity, especially in case of unforeseen events such as natural disasters, geopolitical issues, or pandemics.

Relocate services closer to customers

Transferring projects to a contract manufacturer located closer to their customers can help reduce lead times and transportation costs, which can improve logistics and customer satisfaction.

Our Process for Delivering a Smooth Medical Device Production Transfer

Transferring a medical device project from one contract manufacturer to another can be a challenging and complex process. It requires careful planning, clear communication, and meticulous attention to detail to ensure a successful outcome. As a contract manufacturer of medical devices, we have extensive experience in managing the transfer process and have helped numerous OEMs transfer their projects from previous suppliers. In this article, we’ll outline the steps we take to make the transfer process as smooth and successful as possible.

Assess the Project

Before beginning the production transfer process, we ensure that we can meet the deadline and have a clear understanding of the reason for the transfer. It’s important to understand the OEM’s needs and expectations so that we can ensure that we can indeed deliver where the previous supplier could not. This includes reviewing the client’s technical documents, quality system, and manufacturing processes to ensure that we fully understand the scope of the project and any potential challenges that may arise during the transfer. We also conduct a risk assessment to identify any potential risks to the project’s success and develop mitigation strategies accordingly.By doing this upfront assessment, we can provide the OEM with a clear plan of action and timeline for the transfer process.

Develop a Transfer Plan

Once we have assessed the project, we develop a comprehensive transfer plan that outlines the steps we will take to ensure a successful transfer. This plan includes a detailed timeline, a list of key milestones, and a list of deliverables that must be completed before, during, and after the transfer process. The plan is reviewed with the client to ensure that everyone is aligned on the process and expectations.

Establish Communication

Communication is critical during the transfer process, and we establish clear and regular communication channels with the client. This includes regular progress updates, milestone reviews, and technical discussions to ensure that the project is progressing as planned. We also establish a point of contact on both sides to ensure that any questions or concerns can be addressed in a timely manner.

Perform Process Validations

One of the most critical steps in the transfer process is the validation of the manufacturing processes. We perform a comprehensive validation of all processes, equipment, and software used in the manufacturing process to ensure that they meet the client’s specifications and comply with regulatory requirements. This includes a review of the manufacturing process, development of a validation plan, execution of the plan, and documentation of the results.

Ensure Compliance

As a medical device contract manufacturer, we are committed to maintaining the highest level of compliance with regulatory requirements. We work closely with the client to ensure that all aspects of the project comply with regulatory requirements, including design controls, risk management, documentation, and testing.

Transfer Production

Once all of the steps in the transfer process have been completed successfully, we begin the production transfer. This includes the transfer of all tooling, equipment, and materials required for production. We also work closely with the client to ensure that any required training is completed, and that the production process is fully optimized for efficiency and quality.  

Quasar Cam Make Your Production Transfer Process Seamless and Successful

For medical device OEMs, making the choice to transfer their production to a new contract manufacturer is a serious decision. There are many factors that are at risk, such as maintaining strong regulatory standards, ensuring quality and safety, meeting timelines and budgets and more. At Quasar, we have a dedicated team of experts and a proven system in place that can successfully manage the transition process and bring your product to market on time and at the right cost.  We are committed to providing our clients with a seamless and successful transfer process. By following our strict processes, we ensure that our clients have confidence to choose us as their new contract manufacturer.