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Mayo Enters Medical Device Market

Posted on: Wednesday, 29 March 2006, 15:00 CST

By Jeff Hansel, Post-Bulletin, Rochester, Minn.

Mar. 29--Mayo Clinic is diving headfirst into the medical device market with a monitor designed to help patients avoid unnecessary surgical biopsies.

It's not business as usual. In the past, Mayo Medical Ventures (MMV) would license technology to companies that would take ideas through the development phase all the way to market.

"This is a new model for us," said Steve VanNurden, director of technology commercialization at MMV, a for-profit arm of Mayo Clinic.

Mayo physicians believed they had a good way to improve biopsy methods. When a physician needs to take a biopsy to confirm lung cancer, for example, a needle is used to remove a small amount of tissue. But there can be a problem.

"When you breathe, the tumor will move up and down," VanNurden said.

That makes getting a good X-ray difficult. The options are to use a continuous scan, which also means more radiation exposure, or to find a way to stabilize the tumor's position so the procedure can be finished sooner.

Mayo officials believed they could take such a device to market themselves instead of licensing the technology to a company. But they needed it to be easy to use, adaptable to a wide range of patients and capable of consistently producing high-quality results. So they enlisted designers from IBM in Rochester to help.

The Division of Engineering and Technology Services at IBM took the idea of Mayo physicians, who figured out a way to measure movement during respiration.

"It consists of a hook-and-loop belt with expandable bellows that is wrapped around a patient's upper abdomen or lower chest," a 2003 article published Mayo researchers in the journal Radiology says. From concept-prototype at Mayo to a working IBM wireless device ready for service took only 10 weeks of development, said IBM Division Director Samuel Prabhakar.

The device takes a measurement, which is correlated with a set of lights. The patient's goal is to keep the green light in the middle lit.

"It's an easy thing for them to do, and then the system's able to monitor that -- and then you do hold your breath in the same spot every time," VanNurden said.

For some people, a biopsy can be unnerving. But VanNurden said anecdotal information suggests "the patient is distracted this, so they focus on getting the right lights to light up. So it's a pleasant distraction for them because they're concentrating on getting the lights being in the right spot."

The new medical device is following a similar path to one designed Mayo and approved the Food and Drug Administration in 2003 -- an MRI cuff used to help radiologists see tiny structures like nerves and ligaments inside the wrists, forearms and hands. That device took about 9 months to develop, Prabhakar said. Typically, turnaround is more like a year to a year and a half, compared to 10 weeks for the biopsy device.

"We need to continue to develop new business models," VanNurden said.

It's uncertain when it will make sense to take another device down a similar path.

"We currently get a new idea every day in our office now, and we want to continue to move those ideas from Mayo to helping patients worldwide," VanNurden said.

But the wheels of innovation are turning at Mayo and IBM.

"We're trying to explore into the medical market and grow our expertise in that area," Prabhakar said. His division has 1,200 staff members worldwide and 350 in Rochester, where the biopsy device is being manufactured on the IBM campus.

VanNurden added that the chance for scientists and designers to keep "rubbing shoulders together" in impromptu meetings has benefits. The close proximity of IBM to Mayo, he said, "is very beneficial for us."

The Cost of Health Care:

The American Lung Association of Minnesota says a needle biopsy starts at around $1,000.

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Source: Post-Bulletin

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