Medical Device Link.

MPMN: In addition to smaller sizes and tighter tolerances, what are some of the changes you've seen taking place in recent years while providing tubing for the medical device industry?

Saab: What we're running into is that the people right now that have very high-end applications like implantables—implantable defibrillators and leads—are not just concerned with short-term properties. Now, we need to worry about the molecular weight of the material. We need to worry about the stresses that are built in. And so some of our customers are giving us a series of tests that they want the tubing to go through to simulate what's going to happen long term. It's not really an aging test, but a number of different tests that give them an indication of how the material's going to perform. There's a lot more testing and a lot more process control.

Customers want to control the materials going into the tube and they want the materials going in sampled. Some of our customers are actually supplying the materials going in so we're actually screening the raw materials; some are having the raw materials custom made for them at incredible costs and they're controlling that raw material and they're requiring us to control and validate our processes because they don't want any changes in the extrusion process. In the old days, people really didn't look at how you got there. They looked at what you started with and what you ended with. And if the end product met the dimensional requirements, looked good, and met the visual requirements customers were happy, whereas with a lot of these applications, they're very concerned about how you got there—what exactly you did in the process and they want to make sure you do the same thing every time.

In the last three years, we built two new extrusion lines—one from scratch and then rebuilt an existing line and put all types of process control capability in there and controls over temperatures, pressures, things that people never thought of looking at in the extrusion process. Now, we're measuring and controlling it because customers want to know that every one is the same.

MPMN: Do you feel that a lot of tubing suppliers are being forced then to change their processes as well, or is your company ahead of the game?

Saab: It's still only a small percentage of end-users that are requiring this, but what's happening is as we do these things for them, we get much smarter in terms of what we need to do to control processes and then start applying these things to other products that we make and all of a sudden you can improve the performance of those products and the repeatability. For example, we make balloons with a lot of our tubing, and our ability to make balloons is very much dependent on not just the dimensions of the tube, but the other properties of the tube as well: the molecular weight, the orientation, the stresses in the material, the defects…By controlling those things, we are able to make a much more repeatable tube component that goes into our processes of making balloons; we can sell that as a benefit to our customers.

MPMN: As processes change, have you seen a change in materials as well?

Saab: Most of the materials have stayed the same—there's a lot of custom formulation, there's a lot of tweaking of materials and blending of materials. People are working with some bioabsorbable materials—those are new and very expensive, but those have very limited applications. It's the same basic materials, but we're fine-tuning formulations and pushing raw materials suppliers to supply more-consistent raw materials.

MPMN: Have you had to change your processes to accommodate continually shrinking designs for minimally invasive surgical applications?

Saab: We've had to modify a lot of our equipment. We will buy a commercial extruder, for example, but all of the other pieces of equipment on the line we have to either make or modify because we're not really set up to do the things that we're being asked to do: the really small diameters, the thin walls, or the tight tolerances. So, you end up with a lot of investment in tooling, equipment, and much tighter tolerances on tooling. Ten years ago, you'd make tooling and you could put a tolerance on the tooling of ±0.002 or so. Now, it's everything is 0.001 or under. Every tool, every component, everything is being pushed as far as we can because if we can run a better tube and measure it, the customer will want it.

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