The mantra of many catheter manufacturers that employ manual bonding and assembly processes seems to be the old adage: “If it ain’t broke, don’t fix it.” And that’s all well and good until a recall occurs, FDA comes knocking, or a quality issue arises, according to Amit Arora, global market development manager at East Providence, RI-based Nordson EFD.

Despite the increasing trend in manufacturing toward automation and increasingly high-tech equipment, manual methods are still relatively common for such catheter assembly operations as balloon attachment, marker bonding, tube joining, and connector bonding. Operators frequently use squeeze bottles for manual dispensing of adhesives, Arora notes, or they dip tubes into adhesive or glue, remove excess material, and then manually bond the catheter to a connector or other component. 

“Whenever a human operator is dipping a tube into a dish full of glue and then tapping it onto the table [to remove excess material], you’re introducing variability into your process,” Arora says. “So, the catheter that you’re manufacturing today may not be exactly the same as the one you’re manufacturing a year from now.” Or even an hour from now.

And that’s a potentially big risk in these ISO 13485-certified facilities in which process control is key. Variability and inconsistency between catheters are inevitable with manual assembly because—simply put—operators are not infallible and are not robots; they’re only human.

Moving away from a reliance on manual assembly and incorporating fluid dispensing equipment, however, can reduce variability and increase process control, according to Arora. “If there’s a recall of your catheter and FDA comes after you, you have complete traceability as to exactly which equipment was used to manufacture this batch and what the dispensing parameters were,” he says. “That gives manufacturers more leverage and more confidence when getting back to regulatory agencies.”

Dispensing equipment also offers the potential advantage of reducing waste and, in turn, costs. Arora admits that some companies are reluctant to invest in dispensing equipment—or any process or equipment changes—when facing tighter budgets in light of pricing pressures and the onerous medical device tax, for example. “But it absolutely cuts costs over time,” he says. “People don’t always think about the cost of ownership or whether they’re wasting the material or fluid they’re purchasing.”

For complex catheter assemblies, dispensing systems may also save time. Operators performing manual bonding and assembly tasks that require very high precision, for instance, would likely double- or even triple-check their work to ensure quality. Precision dispensing systems, on the other hand, ensure confidence from the outset in the amount of fluid dispensed, Arora says.

“Ultimately,” he says, “[dispensing systems] offer lower cost per finished product because of less material usage—which means less waste—while greater process control leads to better product quality and reliability.”

 —Shana Leonard, group editorial director, medical content
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