How to Choose the Right Balloon Catheter Manufacturing Partner- Expert Q&A

Selecting the right balloon catheter manufacturing partner is a critical decision for medical device companies looking to bring life-saving technologies to market. From material selection and vertical integration to supply chain security and scalability, the factors at play can directly impact performance, quality, and speed to market. With more than two decades of experience in balloon catheter innovation, Confluent Medical Technologies has helped OEMs, from startups to global leaders, navigate these complexities. In this Q&A, we sit down with a Confluent balloon catheter specialist, Ryan Phife,  to discuss what sets Confluent apart, the capabilities required for success, and what OEMs should consider when choosing a trusted partner. 

1. What is Confluent’s history with Balloon Catheters, and what sets them apart from other manufacturing partners?

Confluent has a 20+ year history with Balloon Catheters dating back to the founding of Interface Associates by Joe Stupecky in the late 1990s, with balloon forming machines and catheter manufacturing equipment. Interface Associates invented and designed high-level equipment that pushed balloon catheter manufacturing to the next level, eventually leading them into the contract manufacturing space for balloons and balloon catheters using industry-leading equipment. Confluent Medical Technologies was formed by the merging of Interface and Nitinol Device and Components, which combined the long history of balloon forming and the high volume manufacturing ability in Costa Rica that established this company to provide vertically integrated development in the US and well-established high volume manufacturing at our Costa Rica facilities. 

2. What capabilities and technologies are required for the development and manufacture of balloon catheters?

One of the most important capabilities required for the development of balloon catheters is being vertically integrated in the various components that go into the catheter assembly. Confluent has been designing and extruding their own tubing for decades, which allows for better control of the manufacturing process, particularly critical in balloon forming, which allows us to quickly adapt and modify our components to achieve the customer’s needs. Confluent has also invested in many common catheter areas that allow us to offer many insourcing options for customers, such as over molding, coating services, tip forming, pad printing, braiding/coiling, etc., that minimize risk for our customers. 

3. How important a factor is material selection in the development of balloon catheters? What materials are most commonly used? What attributes are required?

Material selection is critical in the development process, as many of our customers (from start-ups to some of the biggest names in the industry) request our assistance in recommending materials for their design needs. Confluent has a long history with a wide range of materials from common PTA catheter choices like Grilamid balloons and Pebax shafts to HDPE trilayer extrusion for lubricity assistance to Pellethane shafts for ease of bonding occlusions balloons, and various compounds when customers are seeking an increase in pushability and we might recommend a blend of stiff material like TR55 or MX Nylon. 

4. The medical device supply chain is facing reevaluation for a number of reasons. Can you speak to the supply chain for balloon catheters, best practices, and what to seek in a manufacturing partner?

The best attribute you can find in a manufacturing partner is vertical integration. Balloon catheters are an assembly process that requires understanding the interactions between all the pieces that you are putting together. When an unusual or unexpected interaction occurs between materials, the root cause or development process is much easier when you are going to another department within your company to solve the issue than working with an outside vendor. Confluent has spent years investing in growing our capabilities through acquisition (Corpus Medical for advanced catheters or Tube Hollowing for gun drilling) and ground up development (Founding our Austin facility for complex catheters and Chattanooga for Polyimide and filmcast tubing) that allows us to add more tooling to our kit that we can offer our customers. 

5. How can the right balloon manufacturing partner help with time to market and scalability to keep up with demand?

A balloon manufacturing partner can best assist their customers with time to market by having a well-established pathway to high-volume manufacturing, plenty of space/capacity/flexibility at the manufacturing sites, and a robust quality system that supports these actions. Confluent’s Orange County facility has been developing and transferring balloon catheters to our Costa Rica facility since 2017. I have personally transferred two projects myself that were designed and developed the initial catheters as well as DV units in the US, and transferred them to Costa Rica, and are currently in high volume production. Confluent established it first footprint in Costa Rica in 2010 for wire forming and electro polishing Nitinol components, and since grown into 5 different buildings within the Coyol Free Trade Zone with knowledgeable personnel who understand, maintain, and grow our capabilities for production manufacturing. 

6. What’s commonly overlooked with regard to balloon catheter manufacturing? What should OEMs consider before or while working with a manufacturing partner?

OEMs should work with balloon catheter manufacturers that have a good understanding of the ISO requirements for catheters, along with the statistical requirements that you can find in the PTA and PTCA guidance documents provided by the FDA. Companies are finding new and novel ways to use balloon catheters, but the basis of the design is well established with submission guidelines that show what worst-case sizes to test and recommendations on confidence and reliability values that any balloon manufacturer should know, even if they aren’t the design owner. For example, balloon catheter burst strength has an unusually high C&R (95% / 99.9%) that should be known and calculated by any manufacturing partner. 

7. Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

The relationship between the extrusion team (internal or external) and the device manufacturing team is critical. Balloon manufacturing requires a deep understanding of the extrusion process to produce consistent products that meet specifications. There are many other processes as well that require a close relationship with extrusion, such as overmolding or thermal bonding, or tipping. Extrusion lines are expensive and space-consuming efforts, but they will pay off in the long run for producing better products as well as quick development and problem-solving that will help OEMs get their product on the market faster and stay on the market longer.