Company hopes monitor is ‘game-changer’

April 14, 2011 at 12:00a.m.

McClatchy Newspapers

MILWAUKEE, Wis.

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 percent that of a traditional ECG device, he said.

Initially, 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.

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.

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.

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.