Guide to the Catheter Development Process
If you think developing a catheter is as simple as just putting a straw in a drink, think again! The journey from concept to high-quality medical device is a complex adventure, and we at Prevailing Medical are here to guide you every step of the way.
Transforming an idea into a fully functional medical device involves a detailed process that integrates design, rigorous testing, development, and regulatory compliance. At Prevailing Medical, we specialize in creating high-quality catheters, including complex catheters, valve delivery systems, EP catheters, and sensor integration. In this guide, we will take you through the key stages of our catheter development process.
1. Initial Concept and Design
In Phase 1, we engage in collaborative brainstorming sessions to evaluate the practicality and potential impact of your concept. By leveraging our expertise and advanced modeling software, we translate ideas into designs, ensuring that they are both feasible and aligned with your specific needs. This collaborative approach helps refine designs, setting the foundation for successful partnership and catheter development.
2. Prototyping and Designing
In Phase 2, our design team translates your concept into detailed blueprints and prototypes using advanced design software. This rapid prototyping process benefits the development cycle by enabling a build, test, iterate approach, ensuring optimal functionality. Additionally, we carefully select appropriate materials based on application and performance requirements, further enhancing the efficacy of your device and ensuring your product will be fully manufacturable.
3. Testing, Verification, and Validation
In Phase 3, each prototype undergoes rigorous testing and validation to identify and address potential issues early in the process. This step is crucial for ensuring that the final product is safe, effective, and reliable. We conduct various functional tests to assess catheter performance, including flexibility, strength, and biocompatibility. At Prevailing Medical, we prioritize regulatory compliance by going through rigorous testing protocols that meet industry standards.
4. Manufacturing and Production
In our 25,000 sq. ft. facility, we seamlessly transition from prototyping to full-scale manufacturing, tackling challenges with solutions. Our quality control measures ensure that every catheter meets the highest standards. Our 2,400 sq. ft. ISO Class 7 cleanroom allows space for the manufacturing of components, assembly of product, and packaging of multiple product lines. With decades of experience, we excel in both low and high-volume production while maintaining a high-touch collaboration process built on transparency and direct communication.
Key Takeaways
Developing high-quality catheters involves a comprehensive process from initial concept to full-scale manufacturing. Prevailing Medical is committed to innovation and quality while upholding the highest standards for our customers through open and honest communication. Contact us today to discuss your design and development needs and bring your ideas to life.
