From Idea To Market: Caledonia Firm Chips In

June 16, 2008
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Aspen Surgical Products Inc. of Caledonia worked with Borgess Research Institute’s Dr. Tim Fischell to create a marketable product out of his idea for a new medical device, Ostial Pro.

The Ostial Pro was born of Fischell’s frustration with the difficulty of placing cardiac stents near the juncture where arteries branch off from each other. The device consists of a nitinol wire, a small housing at the tip and a five-petal, gold-plated flower that emerges from it to stabilize a catheter against the wall of a blood vessel. The Ostial Pro is inserted into the catheter and allows accurate placement of the stent.

“In the end, it came out simple, and it really works,” Fischell said. “It solved a problem that no one else has solved, ever.”

Aspen Surgical plans to ramp up production of the new device this month at its 25-employee wire plant in England, said Mark Zyzelewski, vice president of product development. Final assembly and packaging will be done at its Caledonia plant, at 6945 Southbelt Drive SE.

COO Terry O’Rourke said Aspen specializes in manufacturing one-time use medical devices in five categories: instrument care; wound care; ophthalmology products; endoscopy and ear, nose and throat products; and patient and staff safety products. One of its biggest sellers is surgical needles, he said. The company employs 220 people in Caledonia.

Aspen Surgical was founded in 1999 by Dan Bowen, who sold the company in 2006 to Roundtable Healthcare Partners, a private-equity firm in Lake Forest, Ill. In 2007, Aspen made four acquisitions, O’Rourke said.

“Three out-of-state businesses were acquired and moved into Michigan,” O’Rourke said, adding that the fourth acquisition was the plant in England. “We’ve grown employment pretty significantly. We’ve created a lot of good jobs.”

Bowen, who remains on the company’s board, said annual sales are about $50 million.

“In one week, about three and a half years ago, I had three ostium right corners and I missed all three in a row,” Fischell said. “And I’m really good. I’ve put in 6,000, 7,000 stents. I know how to put in stents. I really pride myself on being a very good operator and very meticulous, and I can’t figure out where the ostium is.

“I invented it because it drove me crazy.”

Misplacing a stent is an expensive way to work, Fischell noted. If the first one isn’t perfectly located, a second one must be installed — and at $2,000 apiece, that can be a pricey duplication that extends the time its take to perform the procedure. He said the Ostial Pro is expected to sell in the $700 range, making it a cheaper alternative for potentially tricky cases.

“We think it’s probably $40 million or $50 million worldwide,” he said.

He worked with Aspen’s Zyzelewski for three years to perfect the design. Zyzelewski said even though the Ostial Pro seems straightforward, many factors had to be considered in its design, such as its ability to function inside different sizes of catheters, which metal would work best both inside the body and in manufacturing, and how to package it to maintain sterility.

“We went through 10 to 15 different iterations of the device, until we got it to fit what Dr. Fischell wanted,” Zyzelewski said.

After testing on animals and human trials, the Federal Drug Administration approved the Ostial Pro in May 2007 for use in any blood vessel, said R. Kevin Plemmons, CEO of Ostial Pro Solutions. The product is expected to be on the market in a matter of weeks.

Ostial Pro has about 20 investors, Plemmons said. “We’ve really done it on a shoestring budget,” he said. “We are in the process now of shopping our company for two things, an outright acquisition by a major company or we could do a licensing agreement with a number of companies.”

But Plemmons said he is content to build a marketing force in the meantime. “They are more than happy to pay down the road for performance and minimizing their risk,” he said.

The medical device business depends on a constant flow of new ideas and small companies nimble enough to bring them to the marketplace, said Mark E. Brager, director of communication for the Advanced Medical Technology Association, a trade association for medical device manufacturers.

“Eighty percent of the medical technology industry is composed of companies with fewer than 50 employees. This is an industry where you don’t have to be huge to thrive. All you need is an innovative idea. You compete on intellectual property,” Brager said. “The industry is marked by rapid innovation. The average life cycle for some technologies is as little as 18 months.”    

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