The process of developing a bladder and commercializing it can be long and difficult depending on the number of different designs and testing procedures.
This process includes bubble development through in-depth market research, multiple design concepts, prototypes, and successful transfer of devices to test, manufacture and prepare for commercial release. You can also visit https://www.pobamedical.com/ to know more about medical balloon transfer.
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Balloon catheter technology transfer process
1. Make a transfer plan
Once the balloon design is finalized and tested, we can prepare to transfer the design to production. Successful project transfer requires a thorough review of project documentation and regulatory standards.
2. Validation plan
Writing a detailed validation plan is an important step in obtaining regulatory approval as it involves reviewing the proposed system, identifying responsibilities, and describing the overall quality management system.
The validation plan includes inputs and outputs for the design at each phase of bubble development, identified acceptance criteria, and project tracking and review methods.
3. Commercial launch
Once the final regulatory approvals, you can put the bladders into production and prepare for commercial release. This phase also requires a discussion about how to prepare to launch your new device to the desired customer.
The launch does not signal the end of the bubble development cycle as it requires careful evaluation of the device in the selected market to see how it performs outside of the test environment. The market data collected can start a cycle of new concepts and ideas for improvement.