INRAD Inc. president and part-owner Ryan Goosen displays company products.

INRAD introducing three new medical devices
Pete Daly

	Matthew Williams inspects the SelectCore products at INRAD Inc.

The INRAD employee roster, which was cut back in 2007, is expected to increase again this year — although neither situation was or is a result of economic shifts. Rather, it's a mark of the company's abilities in product development.

INRAD Inc., a developer, manufacturer and distributor of medical devices for radiology and biopsy procedures in 30 countries around the world, just began sales last week of SelectCore, the first of three new products the company is introducing this year.

Located at 4375 Donker Court SE in Kentwood, INRAD now has almost 20 employees but expects to add more as a result of the new product lines, according to president and part-owner Ryan Goosen.

When INRAD eliminated about five jobs in 2007, it wasn't due to any problems the company was having; it was due to the sale of two of its proprietary product lines to Bard Biopsy Systems of Tempe, Ariz.

Bard, a $2 billion global company, "made Steve an offer he couldn't refuse," according to Goosen, referring to INRAD CEO and owner Steve Field. The two product lines — tissue markers and breast localization wires — that INRAD had developed had become the major part of its production, so when Bard bought the rights to make and sell them, INRAD suddenly had some employees with nothing to do.

Goosen said much of what INRAD was developing at that time was related to those two products, "so we had to shift gears and go after something else, due to the non-competes that we signed."

The tissue marker developed by INRAD places a tiny piece of stainless steel or titanium in tissue, marking the exact spot where a biopsy sample was taken, for future reference. The breast localization wires are used to exactly mark cancerous tissue that must be surgically removed.

Bard is still marketing the devices under the product names INRAD had given them: the UltraClip Breast Tissue Marker, UltraWire, Ghiatas and Chesbrough Breast Localization Wires.

Since the sale, INRAD has focused on development of products related to core biopsy procedures, with the goal being the reduction of uncertainty in diagnosis by providing devices that offer more precision to the medical practitioner. Today, the company has more than a hundred different catalog codes, according to Goosen, and those products are in use in more than 2,000 hospitals throughout the U.S. and 30 other countries.

The INRAD name was established in 1981 as a part of DLP Inc. in Grand Rapids. In 1994, DLP and its INRAD division were acquired by Medtronic Inc. In 1997, Field, who was a key executive at INRAD, bought the business from Medtronic. Since then, INRAD has firmly established itself in the regional medical device community, being one of the founding members of the West Michigan Medical Device Consortium.

Of the three new core biopsy devices, two are "pretty complex," according to Goosen. "In the past, we typically had devices that ranged from five to 10 components, and now we're in the 25 to 30 components range, to put some of these things together," he said.

INRAD products range in price from $40 to about $250. Most of them are disposable devices, intended for one-time use.

A big product in 2010 will be the SelectCore, which is essentially a hypodermic needle that incorporates moving parts. It can remove samples from any soft tissue, said Goosen, such as the liver, lungs, kidney, prostate gland and breast.

Another device that goes on the market in late January is the PreciseCore, which was developed by INRAD based on a suggestion from a Chicago doctor. Goosen said it is a manual device for taking core biopsies in critical tissue areas, such as lymp nodes, where a doctor must have extremely precise control.

The third new product, Revolution, is designed specifically for breast biopsies and is already a registered trademark.

"That's our most complex device," said Goosen, explaining that although it is the same size as a 14-gauge needle, it can retrieve twice as much tissue. He said when the Revolution is "fired" into the target area, a retracted piece at the tip of the needle straightens out and revolves 360 degrees to precisely cut the required tissue for removal.

All three devices are mechanical in nature, powered by springs. The more sophisticated devices are considered fully automatic because they "do everything" with one press of the trigger, according to Goosen.

Most of the core biopsy products INRAD produces involve a hypodermic needle, except for the accessory product lines that are used in support of the biopsy devices. INRAD does not manufacture the hypodermic needles; they are supplied by about five different American companies to design specifications developed by INRAD. Most of the companies are on the East Coast but one that occasionally supplies needles is Hart Enterprises in Sparta.

The completed devices include plastic components. Although they have always been designed by INRAD engineers, those parts were once supplied by an injection molding company in West Michigan. However, Goosen said that supplier was planning to drop that type of production, so INRAD added its own in-house injection molding machinery when it moved into its 20,000-square-foot plant on Donker Court a few years ago.

INRAD does its own assembly and packaging in a Class 10,000 clean room. Even the injection molding equipment is in a clean room, albeit a lower Class 100,000.

Almost a third of its work force is made up of engineers, according to Goosen, 34, who is a mechanical engineer himself but also armed with an MBA. Goosen, a native of Coopersville, was torn between a career in medicine or in engineering, so he took pre-med courses at GVSU while earning his engineering degree.

"I went to college to get into medical devices," said Goosen, who worked at Medtronic when he was in college.

INRAD has three full-time engineers plus three co-op students from the GVSU engineering program who temporarily work full-time there as part of their education.

INRAD does its own product development, but not in an isolated setting removed from actual medical practice. As it makes clear on its Web site, "INRAD is always looking for new product ideas. All of our innovative ideas have come to us from creative doctors who use these or similar products every day. These doctors know the problems they face and come up with solutions to these problems. It is much better for us to develop a product based on real world problems rather than developing a product based on our impression of the real world. We welcome your ideas."

In fact, the company has a highly refined legal procedure for working with doctors who want to submit an idea to them, to protect the intellectual property rights of both the doctors and INRAD.