By Sean Fenske, Editor-in-Chief

With the increasing prevalence of minimally invasive procedures, medical device manufacturers need to develop devices that are aligned with these practices. As such, they require specific technologies to be incorporated into their systems to accomplish necessary medical tasks. One such technology is the balloon catheter, used in conjunction with numerous procedures for treating a variety of conditions.

However, knowing how to develop a medical device and recognizing what to seek out in a manufacturing partner for its fabrication can be two very different challenges. When it comes to a balloon catheter, there are a number of factors that must be considered to identify the right company to assist with a project.

Fortunately, Ryan Phife, Manager of Technical Services at Confluent Medical Technologies, took time to address several questions about the selection process involved for identifying the right partner. In the following Q&A, he speaks to the capabilities and technologies required for balloon manufacturing, material selection, and the benefits the right partner can offer.

Sean Fenske: What is Confluent’s history with balloon catheters, and what sets the company apart from other manufacturing partners?

Ryan Phife: Confluent has a more than 20-year history with balloon catheters. With balloon forming machines and catheter manufacturing equipment, Joe Stupecky founded Interface Associates in the late 1990s. Interface invented and designed high-level equipment that pushed balloon catheter manufacturing to the next level. This eventually led them into the contract manufacturing space for balloons and balloon catheters using industry-leading equipment.

Confluent Medical Technologies was formed with the merging of Interface Associates and Nitinol Device and Components. This marriage combined the long history of balloon forming with high-volume manufacturing capabilities in Costa Rica. This blending helped to establish Confluent as a provider of vertically integrated development in the U.S. and a high-volume manufacturer in Costa Rica.

Fenske: What capabilities and technologies are required for the development and manufacture of balloon catheters?

Phife: One of the most important capabilities required for the development of balloon catheters is being vertically integrated to enable the manufacture of the various components that go into the catheter assembly. Confluent has been designing and extruding its tubing for decades, which allows for better control of the manufacturing process—particularly critical in balloon forming. With such an established setup, we can quickly adapt and modify components to meet customers’ needs. Confluent has also invested in many common catheter capabilities that allow us to offer numerous insourcing options for customers, such as overmolding, coating services, tip forming, pad printing, braiding/coiling, etc., minimizing risk for our customers.

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

Phife: Material selection is critical in the development process, as many customers (from startups 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 tri-layer extrusion for lubricity assistance. There are also Pellethane shafts for ease of bonding occlusion balloons. We can offer various compounds when customers are seeking an increase in pushability, and we might recommend a blend of stiff materials like TR55 or MX Nylon.

Fenske: 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?

Phife: The best attribute you can find in a manufacturing partner is vertical integration. Balloon catheters involve an assembly process that requires comprehension of the interactions between all the pieces being put 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 when working with an outside vendor. Confluent has spent years investing in growing our capabilities through acquisition (e.g., Corpus Medical for advanced catheters or Tube Hollowing for gun drilling) and ground-up development (e.g., founding our Austin facility for complex catheters and Chattanooga for polyimide and filmcast tubing), which allows us to add more tooling to our kit that we can offer our customers.

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

Phife: A balloon manufacturing partner can best assist its customers with time to market by having a well-established pathway to high-volume manufacturing, plenty of space/capacity/flexibility at 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 involving catheters that were initially designed and developed in the U.S. and transferred to Costa Rica (including the design verification units), where they are currently in high-volume production.

Confluent established its first footprint in Costa Rica in 2010 for wire forming and electropolishing Nitinol components. Since then, the facilities have grown across five different buildings within the Coyol Free Trade Zone with knowledgeable personnel who understand, maintain, and grow our capabilities for production manufacturing.

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

Phife: I think the OEMs should work with balloon catheter manufacturers that have a good understanding of the ISO requirements for catheters, along with the statistical requirements 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. Submission guidelines show what worst-case sizes to test and offer recommendations on confidence and reliability values any balloon manufacturer should know, even if they aren’t the design owner. For example, balloon catheter burst strength has an unusually high cost and return (95%/99.9%) that should be known and calculated by any manufacturing partner.

Fenske: 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?

Phife: 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, like overmolding, thermal bonding, or tipping. Extrusion lines are expensive and a space-consuming effort, but they will pay off in the long run by producing better products. In addition, these lines enable quick development and problem solving that will help OEMs get their product on the market faster and stay on the market longer.

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