Effective catheter design and development are critical to bringing your new device idea to market successfully. From the early stages of concept development to full-scale production, this is a complex process with several considerations and potential challenges that can hinder success.
However, with the right approach and experience, opportunities exist in several areas, from getting the design right early in the process to minimizing manufacturing costs and getting your product to market in the shortest possible time. Continue reading to know more about the best medical balloon testing.
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Purpose of Using Your New Catheter Device: You must develop a clear definition of the purpose of your new catheter device as early as possible, as this will determine the direction of the design and development process.
Performance Considerations: There are a variety of features and characteristics that may apply to your new catheter device, but key performance considerations include the outside diameter profile, flexural strength, torque control, transmission capability, compressive strength, and lubrication.
DFM and DFA: DFM is a production design and DFA is an assembly design. These are the two main design considerations that take into account the stages following the completion of the catheter design.
The goal is to ensure that devices can be manufactured and assembled at scale and a reasonable cost.
Approval Process: Your new catheter device must be approved by the regulatory authority in your target market. The best time to start thinking and planning regulatory approvals is early in the catheter design process. So this should be a design consideration from day one.