[Phillip M. Leopold]

Editor's note: This article originally appeared in the Winter 2009 issue of MICROmanufacturing magazine.

My son, Andy, and I bought Medical Murray Inc. in 1996. We design, develop and manufacture molded medical devices especially for minimally invasive treatments in three major areas—vascular, surgical and urological.

Medical Murray, headquartered in Barrington, Ill., began as a mechanical consulting engineering company, with maybe a fourth of its business in the medical arena. We knew from the start that we were going to go 100 percent into medical devices. We both recognized that there was a growing emphasis [in the medical arena] to make things smaller and saw the potential for using molding to do that. We specialize in making custom catheter systems and components, complex disposables and implantable devices.

The biggest challenge in working at the microlevel is to get the molds to the needed precision, because the devices are so tiny. One of the first things we did was to build an injection molding machine that incorporates a linear motor, which was fairly new at that time. We designed the machine so that a very small volume of plastic would melt, which we could precisely control as it was injected into the mold. In fact, the machine can be filled with 3 grams of material, so high-cost materials can be molded with minimal loss.

Another important feature of the machine is its ability to inject plastic very fast. This allows thin areas of the mold to fill before the melted plastic solidifies. The linear motor moves the injection ram at the rate of 1 meter per second. By comparison, typical hydraulic presses move at 0.2 m/sec. and ballscrew-driven electric presses move at 0.4 m/sec.

When making devices that go into people’s bodies, you avoid rigid materials; you want something soft. For the most part, the materials used are polyurethane or silicone rubber.

The primary ticket to the medical device game is the ISO 13485 medical quality certification. We don’t distribute products to the end user, so we don’t have to be registered by the U.S. Food and Drug Administration.

Many manufacturers interested in entering the medical device industry ask how much volume there is and how much money they can make. They see that the field is growing and the work is remaining in the country—at least for high-end products like complex catheters that cost from $100 to $1,000 or more. Getting those types of products made offshore can’t be justified because of the high transfer and training cost, and because their volume is fairly small—maybe a few thousand a month. And while traditionally there have been pretty high margins in the field, some of those margins are needed to help cover quality systems and associated liability issues.

Many of the companies interested in the medical device industry don’t realize how long it takes to get a job from concept to production. We have several products now in production that we first started working on 8 years ago. We have as many as 30 to 40 different projects in varying stages of development going on at any one time. Some might be on hold because we’re waiting for FDA approval or for some testing to come back; others are active because we’re making parts for a project’s next round of testing, and so on. About 10 percent of product concepts make it to final production, so it’s important to have different projects in different stages of development in order to stay busy.

It can be difficult to get on a big medical company’s approved-vendor list. As in any other industry, the larger companies don’t want 500 vendors for a part. They want one or two that are qualified and that they can work with. It’s rare that an OEM will switch vendors because of all that’s involved in getting the vendor qualified, the parts certified and conducting the requisite biocompatibility testing.

The best strategy for getting on OEMs’ vendor lists is to be available and help them solve a problem that had been insurmountable. You make contact with people there so they know you and come to you when they need help. And then—as one of their “go-to” sources—they’ll call on you again to help them on other projects. µ