Technical challenges for manufacturers of medical tubing literally come in all shapes and sizes – representing to some extent the infinite forms their products can take. Those manufacturers have lots of experience when it comes to solving the issues issues that arise in planning and executing the manufacturing process, and they’re of one voice when they declare “We can do it.”

In recent conversations, representatives of companies involved in the medical tubing manufacturing process – from producers of plastic tubing to a maker of metal tubing – were asked by MedicalDeviceNow about the technical challenges they face in meeting their customers’ requirements.

Of particular interest in our queries was the science behind current tubing trends, wondering how a company’s clinical requirements enter into the process as far as suppliers are concerned.
Bob Jennings, vice president, sales and marketing for Zeus, an Orangeburg, S.C.-based supplier of fluoropolymer tubing, talked about clinical validations, saying that Zeus’s customers “want to make sure that whatever they start with and do their bioburden testing on and get their first articles on,” that’s how they want the process to remain.

“Once you lock in your process to given parameters and given material compounds, they don’t want you to change it,” he said. “That’s the environment we live in right now – one of no change. You have to be able to lock it in and not change it.”

And, added Jennings, “if anything in your supply chain that goes into that changes, if you get a notification of some change of some component that goes into what you are making for the customer, then you have to notify the customer, get their approval of the change, or do they need to approve the change or can they just do a simple letter to file?”

That, he said, “is a big deal right now in terms of being in compliance with what your customers are asking you to do, because that’s what the FDA is coming in and auditing them for. When they say, ‘We want to see how you manage your supply chain,’ they want to make sure that the device company that buys these components have good specs in place and that they are controlling their suppliers.”

MedicalDeviceNow noted, “That’s having a real impact in terms of FDA attention these days, right?”
Jennings replied, “If you’re not prepared for it, you betcha.”

As to the question of technical challenges in general, he said, “The people challenge is our biggest one – finding the right people to bring in with knowledge to help us advance, to complement our existing internal knowledge.”

For instance, Jennings said, “If we’re going to go after some new material that we don’t work with, we may think, ‘OK, we know how to process some materials that are sort of in that stratosphere, so how do we find someone out there who can help us get there?’”

Krissi Heard, a technical sales specialist for Tampa, Fla.-based MicroLumen, a producer of polymide tubing and custom co-extrusions, sees its customers’ desires in basic terms as well. “They’re simply looking for tubing that solves problems – that has multiple things going in at one time,” she said. “They want a tube that can satisfy a lot of requirements. Our tubes are part of those devices, so anytime you need to travel through tortuous paths in the body, there are technical challenges to be met in their manufacture.”

As for the impact of customers’ clinical requirements on MicroLumen’s processes and procedures, Heard said, “It requires us to move at a much faster pace in terms of lead times because of their clinical trial schedules. In some cases, it’s a question of us learning as we go along.”
In terms of technical challenges per se, she said that sometimes the processes required for certain work “requires us to build our own equipment because we can’t buy what we need – that takes time and money.”

Jeff Moffo, sales manager for Micro Tube Fabricators in Middlesex, N.J., a maker of precision formulated metal tubing, said, the largest technical challenge is in the engineering and R&D areas. “For instance, the OEMs are constantly tightening up tolerances, etc. That’s what we see most often, people coming in with tolerances that a very difficult to hit. But of course, we do hit them – it’s a challenge, but we’re here to meet such challenges.”

Frank East, marketing manager for Paso Robles, Calif.-based Specialty Silicone Fabricators, a contract manufacturer of customer silicone  components for the device industry, said technical challenges are an expected part of the process. “It depends on what the customer wants.”
He added that for SSF, one internal challenge was in meeting the challenges to get its plant in Tustin, Calif., FDA-certified. “It took us fully a year and a half to get set up and approved in Tustin (Calif.),” East said.