Paul Schultz (left), vice president of quality control, inspects the Spaulding IQ as the device is attached to Mark Ediger, a telemetry technician. Brock Heinz (right) helped develop the software. Credit: Michael Sears

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The task Spaulding Clinical Research LLC faced in trying to create a new device for measuring heart rhythms was simple:

Make it much smaller than any comparable machine. Enable it to identify the subject automatically and record significantly more data. Have it send the information to a central lab with the simple push of a button.

And by the way, make it much less costly than any similar device.

Undaunted, Spaulding Clinical's team figured it out. A year after the project began, the company has gotten clearance from federal regulators to use the device.

Called the Spaulding IQ, the electrocardiogram is designed for use in drug testing trials. It's hooked up to test subjects and measures the electrical activity of their hearts during the drug trials to make sure the compounds aren't harming them.

The doughnut-sized ECG records more heartbeats, includes a "voiceprint" feature that identifies each subject's voice and attaches it to their data, and lets technicians simply push a button twice and attach the device to a computer to send data, said Jay Mason, Spaulding's chief medical officer. Its cost is about 10% that of a traditional ECG device, he said.

Initially, the West Bend company will use the ECG device to expand its business into Phase II and Phase III clinical trials, which test whether proposed drugs are effective. When chosen to be part of a clinical trial, Spaulding will send its ECG devices to participating clinics, which will record the data and send it back to West Bend for analysis, said Randy Spaulding, the company's founder and chief executive.

Currently, Spaulding conducts Phase I clinical trials, which test for drug safety, at its West Bend facility. The company operates in a 200,000-square-foot building that formerly housed St. Joseph's Community Hospital. Spaulding bought the building in 2008 after the hospital moved to a new building in the Town of Polk.

When it has completed field testing of the Spaulding IQ, the company expects to begin selling it commercially, probably sometime this summer, Spaulding said.

"If this doesn't turn out to be a game-changer, I'll be very surprised," Mason said.

No unneeded functions

The new ECG device was designed specifically for use in clinical trials, without all the extras - like the ability to record continuously and print results - that are needed in hospital settings, Mason said. That reduces its cost without sacrificing quality of any of the functions needed for clinical trial testing.

"It's just very focused. And when you focus a product, you can take a lot of the unnecessary costs out," Spaulding said.

Such revolutionary technologies, often called "disruptive," bring new, more cost-effective ways of achieving the same, if not better, results, said Dan Steininger, vice president of BizStarts Milwaukee and co-director of the Successful Entrepreneur Investors angel network.

The most difficult problem with such technologies is getting the market to adopt them, he said. In this case, Spaulding will do the proof-of-concept testing, gaining a competitive advantage before selling the device commercially, Steininger said.

"Instead of having to wait for the market to adopt it, Randy's going to test it and prove it works," he said. "They'll be ahead of the game."

Steininger's angel network took the lead in raising Spaulding Clinical's initial funding round of $1.6 million in 2008.

Spaulding, a biomedical engineer, founded the company in 2007. It has 35 full-time employees, and 85 more who work flexible schedules.

Spaulding was previously vice president of clinical research at Mortara Instrument Inc. and worked for GE Medical Systems as general manager of global cardiology services. Many of those he brought in to develop the Spaulding IQ were people he'd worked with at Marquette Medical, the innovative medical device company founded by Michael Cudahy that was bought by GE.

Mason, a cardiologist, was most recently medical director and director of research and development at Covance Cardiac Safety Services. He is an adjunct professor at University of Utah School of Medicine in Salt Lake City.