An efficient manufacturing design transfer process can help client meet their deadlines and instead focus on the medical algorithms or other treatment modalities.
FREMONT, CA: An effectively run process for manufacturing design transfer optimally results in advanced product delivery and delivers outcomes under budget. Most clients who are the leading innovators in providing therapies for medical conditions depend on a proficient team. They expect the unit to provide timely solutions for scaling the manufacturing process to deliver life-saving medical solutions. Most often, the manufacturing transfer of the device involves the use of an existing design package. The process poses new challenges for optimizing an integrated design team to get the product to market swiftly and competently.
The manufacturing transfer process is vital to a company’s success. The following steps serve as a model for scaling the manufacturing transfer process of medical devices:
• Set up a Design Transfer Process for Swift Production: Be it a newly designed medical device or transferring existing tools, a planning segment can often help establish transport deliverables. Additionally, the process also allows the establishment of any essential master agreements. The agreements can include quality, service, and supply agreement.
• Recognize Exceptional Project Factors if Transferring an Existing Medical Device: Below are a few questions to consider during the process:
- How up-to-date is the design documentation?
- Will the plan require a revision?
- Are there end-of-life components?
- Is warranty or non-warranty service and repair a consideration?
It is helpful for companies to create a core team with regular communication and classify an appropriate escalation path to account for the above considerations.
• Revamp Components to Remove Obsolescence Issues: Businesses should plan a five-year component supply life if possible. They should also ensure that any fit, form, or function impacts are communicated and acceptable. Companies should perform design for manufacturing while administering any design changes. Lastly, building and validating prototypes and pilot builds incorporating any obsolescence redesigns.
• Develop a Feasible Supply-Chain with Readily Available Components: Enterprises need to integrate all machinery into an (Enterprise resource planning) ERP system if probable, ensuring proper supply chain management. Alongside, they also are required to establish supply agreements for any decisive, unique, or non-off-the-shelf components, to guarantee accessibility.
• Simplify the Manufacturing Process: Companies can incorporate the product into the manufacturing cycle and facility, establish a right manufacturing process, and complete the training.