The Catheter Manufacturing Boom

Catheter use first dates back to ancient Egypt. The Egyptians made early catheters from rudimentary materials like wood and reeds—not very durable or sterile—and possibly from gold or silver for the upper echelons of Egyptian society. With the advent of germ theory and the adoption of sterilization procedures and antiseptic techniques in the mid-1800s, catheter manufacturers leaped forward, using rubber and latex materials and laying the groundwork for future innovations.

It wasn’t until the late 1980s that we truly witnessed a shift in catheter technology. Laparoscopic procedures were becoming more common, paving the way for the integration of robotics into modern surgical practices and creating a new field now known as minimally invasive surgery.

To illustrate the magnitude of this change, consider this: patients undergoing a complication-free coronary artery bypass grafting procedure in the 1980s typically faced a hospital stay of around ten days. Fast forward to today, thanks to less invasive procedures, the average has dwindled to approximately three days in the hospital, if not less.

Vascular access technology and catheter manufacturing also changed in response to the shift to minimally invasive surgeries. Innovations such as polyurethane tubing, biocompatible coatings, and reinforced structures have transformed catheter design, enhancing flexibility, durability, and performance. Today, the focus is on optimizing fluid flow and integrating specialized materials to ensure patient comfort and efficacy, especially with sensor-enabled catheters, which are yet another transformative leap in medical technology.

So, why the history lesson? It’s good to understand the context of the current catheter boom. While it may be interesting to know that the Pharaohs may have used golden catheters, the most important takeaway here is that catheters were simple but vital tools throughout human history, but with the exponential advancement of modern surgical techniques that began only within the last few decades—a very, very small period on the larger timeline of catheter history—there has been a surge in demand for more advanced vascular access catheters with greater capabilities. With this surge and the subsequent race for catheter manufacturers to keep up, choosing the right partner in vascular access technology and catheter manufacturing has never been more vital.

For modern catheter brands, your catheter manufacturing partner is paramount for successfully developing your product, especially for vascular access technology in general. A crucial consideration is the partner’s expertise and experience. Companies like Flexan, with a proven track record in this specialized field, offer invaluable insights and capabilities essential for navigating the complexities of catheter production.

Another primary consideration for catheter brands is Cleanroom capabilities and access. It’s essential to assess the manufacturing facility’s Cleanroom standards to ensure the highest cleanliness and product integrity levels throughout manufacturing.

A collaborative approach between the development team and the manufacturing partner is also indispensable. Seek a partner willing to collaborate closely, providing technical expertise and support from conception to commercialization. Collaboration fosters innovation, problem-solving, and, ultimately, the successful realization of the catheter design.

Prioritizing quality assurance measures is another non-negotiable when choosing catheter manufacturers. A reputable manufacturing partner will implement rigorous quality control protocols and adhere to industry compliance standards to consistently deliver reliable, high-quality products.

Considering a manufacturing partner’s global presence can also yield significant benefits. Partnering with a company with a widespread international footprint ensures scalability and accessibility, crucial factors for meeting the demands of diverse markets. A global presence can also facilitate streamlined logistics, regulatory compliance across regions, and access to a broader network of resources and expertise.

Leveraging more than 75 years of industry expertise in custom catheter manufacturing and five Class 7 and 8 Cleanrooms worldwide, Flexan supports OEMs that push the boundaries of design and functionality to enhance patient care. Over the years, we have manufactured groundbreaking devices and components that have revolutionized vascular access technology. One such innovation is the introduction of polyurethane tubing, significantly improving catheter flexibility and reducing the risk of kinks and blockages during procedures. Flexan’s significant expertise in biocompatible coatings, balloons, and radiopaque materials has also helped to ensure patient safety by minimizing adverse reactions and allowing for clear visualization of catheter position under fluoroscopy or X-ray guidance.

As the demand for advanced vascular access technology has risen, Flexan has supported industry leaders with developments like braided wire, lubricious coatings, and improved bonding options to further enhance catheter performance by increasing durability, reducing friction, and facilitating smooth insertion and removal. Most importantly, we prioritize the patient by optimizing catheter designs for fluid flow and minimizing discomfort during procedures, particularly for short-term and long-term clinical applications like power injection or dialysis.

Contact the Flexan team today to learn more about our vascular access technology and catheter manufacturing capabilities.