Five Steps to Creating a Scalable Medical Device Manufacturing Transfer Process
Our clients are some of the leading innovators in providing therapies for medical conditions ranging from COPD to atrial fibrillation and lung cancer. They depend on a competent team to deliver timely solutions for scaling the manufacturing process in order to deliver life-saving medical solutions. Often times, the manufacturing transfer of the device requires the use of an existing design package, posing new challenges for optimizing an integrated design team to bring the product to market quickly and efficiently.
The manufacturing transfer process is critical to a company’s success. These five steps serve as a model for scaling the manufacturing transfer process of medical devices:
- Establish a design transfer process for quick production. For either a newly designed medical device or transfer of an existing device, a planning phase can often help establish transfer deliverables and allow for the establishment of any necessary master agreements. These could include a service agreement, quality agreement, and supply agreement.
- Identify unique project parameters if transferring an existing medical device. Some questions to consider are: How up to date is the design documentation. Will it need revision? Are there end-of-life components? Is warranty or non-warranty service and repair a consideration? It is helpful to establish a core team with regular communication and identify an appropriate escalation path to account for these considerations.
- Redesign components to eliminate obsolescence issues. If possible, a five-year component supply life should be planned for. Ensure any fit/form/function impacts are communicated and acceptable. Perform design for manufacturing while managing any design changes. Lastly, build and validate prototypes and pilot builds incorporating any obsolescence redesigns.
- Develop a workable supply-chain with readily available components. Integrate all components into an ERP system if possible ensuring good supply chain management. Establish supply agreements for any critical, unique or non-off-the-shelf components, to ensure availability.
- Streamline the manufacturing process. Integrate the product into the manufacturing cycle and facility, establish a good manufacturing process, and complete training.
A successfully run process for manufacturing design transfer optimally results in expedited product delivery and delivers results under budget. Because of this, the client can meet their deadlines and focus instead on the clinical algorithms, or other treatment modalities for the next generation device while avoiding unnecessary time and costs spent on the existing design and manufacturing process.