Originally Published MPMN December 2008

TECH UPDATE: MANUFACTURING EQUIPMENT

Small Companies Compete Using Custom Equipment and Automated Processes

Stephanie Steward

Large OEMs have long dominated the catheter balloon market in terms of cardiac applications. In order to compete, smaller companies are focusing on peripheral applications in other parts of the body, such as the knee or esophagus, and are turning to custom manufacturing equipment suppliers to accommodate their larger balloon-forming requirements. As they explore custom equipment options, these companies are also learning how to make more efficient use of their labor force by gradually automating select processes.

Processing and forming longer balloons requires different heat sets, end-plug requirements, and other modifications to balloon-forming equipment. "Extended and higher powered machines were necessary to accommodate the longer length balloons," says Doug Downing, vice president, operations, for Interface Catheter Solutions (Laguna Niguel, CA). The company offers balloon-forming machines that can produce balloons up to 250 mm in length. "The requirements for forming a longer balloon with uniform wall thickness and performance properties demands more control over the complete process, starting with a precision mold," he says. Equipment that compliments longer-length balloons also needs to be adapted to provide consistent performance. To meet these performance requirements, the company has made such modifications as incorporating longer blades on its fluting and wrapping equipment. Such equipment can provide controlled means for tight and accurate wrapping of a fluted balloon around a catheter shaft.

Machine Solutions Inc. (Flagstaff, AZ) has also modified its pleating and folding equipment to accommodate balloon lengths up to 250 mm with the smallest possible profile. Balloons for cardiac applications tend to be about 20–30 mm long, whereas a balloon for a knee application, such as opening up an artery below the knee, may require a balloon as long as 210 mm.

The company also has responded to a push to automate pleating and forming processes to increase reliability for their customers, according to product manager Brian Strini. Strini notes that while smaller companies are driving the demand for equipment for longer balloons, larger companies are pushing for more automation. This push could effectively help speed up the availability of automated systems for these applications and make them more accessible to smaller companies. Choosing to automate specific processes in a manufacturing line can help smaller companies use their labor and resources more efficiently. For example, hand-folding longer-length balloon catheters can be a time-consuming process and the ability to refold upon deflation may differ greatly from unit to unit. Machine Solutions’ automated MSI FFS875S and WS1275 machines have been fitted with pleat and fold heads in 250 mm lengths to address these issues and enable uniform, repeatable processing. And if there’s one thing every company involved in processing balloon catheters can agree on, it’s the importance of reliable, consistent repeatability. “Repeatability is crucial,” emphasizes Downing from Interface.

Smaller companies are finding it easier to automate processes to achieve high repeatability and throughput rates for balloon processing and other applications by partnering with these custom equipment providers. “Automation doesn’t have to be expensive,” says Terry LaRocca, director, Adaptive Manufacturing Technologies (Ronkonkoma, NY), which specializes in custom automated processing and packaging equipment. The company offers services for the custom design and manufacturing of specialty equipment for narrow markets. LaRocca says that small companies can automate a few processes at a time. With some advance planning, it can be more cost-effective to add three or four small machines over the course of a year or so instead of investing in one large automation center.

“In the past two years, we’ve seen smaller companies looking for smaller machines more than big machines, not to cut labor but to make labor more efficient,” LaRocca says. Not only is this strategy resulting in more repeat customers for the equipment suppliers, but small OEMs can see a faster return on their investments, he adds. These smaller machines can pay for themselves in a few months to just under a year.

Copyright ©2008 Medical Product Manufacturing News