The process of developing a bladder and bringing it to commercialization can be long and difficult depending on the number of different designs and testing procedures.
This process includes bladder development through in-depth market research, multiple design concepts, prototypes, and delivery of successful devices to be tested, manufactured, and prepared for commercial release. Continue reading to learn more about urethane medical balloons.
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Product development process with a urethane balloon catheter:
1. Input device design
Medical balloon design inputs serve as the basis for any urethane balloon development project as they represent the functional, performance, safety, and regulatory requirements of the device. They should be clear, objective, and based on consumer needs and goals.
When developing design inputs, it is important to consider details such as industry standards and regulations, past projects, competing products, prototypes, and of course the end-user. It is also important to consider how you will demonstrate that this data has been complied with during the verification process, which requires careful documentation and objectivity.
2. Create a concept
The concept and idea generation phase of urethane balloon development usually goes hand in hand with data input for device design, as functional and performance requirements for balloons can be defined here. During this phase, each function must be managed by the personality of the end-user or buyer.
This requires extensive market and competitor research to ensure you create a successful product. It is important to consider how every conceptual detail will be carried over to the original prototype.