A road less traveled may bring riches.
At least that is the hope at Preventice, a Minneapolis software company whose association with Mayo Clinic is leading it to foray into the world of medical devices.
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The company — formerly called Boost Information Systems and based near Mayo in Rochester — is building a miniature, remote body monitor called BodyGuardian. The device is worn underneath clothes next to the skin and is able to monitor heart rate, ECG, respiratory rate and physical activity, said Judy Eastman, director of product development and management at Preventice. Designed to monitor nonlethal irregular heart rhythm, the BodyGuardian collects the physiological information and transmits it using wireless and smartphone technology to a physician who can monitor a patient remotely.
Preventice licensed the algorithms and clinical practices from Mayo Clinic in November 2010, and Mayo holds equity in Preventice, said Suzanne Leafbrock, a Mayo spokeswoman.
The goal is for the prescription device to fit into a person’s life and allow him to continue with his daily activities without noticing BodyGuardian, Eastman said, in an interview in late March. She added that the device may be something that can help in diagnosing whether a person has a disease.
“If the physician feels that they can’t diagnose the problem based on what the patient is saying, they may send the person home with the device,” she said.
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Eastman described BodyGuardian as “completely innocuous,” but declined to provide more detail about the product given the fact that Preventice is gearing up to file a 510(k) submission with the U.S. Food and Drug Administration.
However, at the Sensor Continuum panel, part of the New York Social Media Week in mid-February, another Preventice executive was more forthcoming about BodyGuardian’s capabilities.
“The shell is 45 mm-by-40 mm,” explained Kyle Dolbow, executive vice president of field operations, as he held up an engineering prototype. “When it goes into production it will be 8-by-8 to give you an idea of how unobtrusive it will get.”
Dolbow added that the device snaps on to Band-Aids that can be worn for seven days and that BodyGuardian measures “hospital-quality ECG.” The prescription device can be preset by a physician and customized for each patient. It can be run in event mode such that data can be transmitted only when a cardiac event is occurring.
“We all know that physicians are bombarded by data so this device can be set for particular events for the patient,” he said.
Then when a cardiac event does occur, the BodyGuardian uses Bluetooth technology to transmit the data from a variety of devices, including smartphones, wireless hub inside the house or a key fob attached to a person’s belt to a server.
“The physician gets an SMS and he can go to his iPad … and get a data slice of (the patient’s) EKG before and after the event according to a preset time window,” Dolbow explained. “He can set the device into the streaming mode if he needs more information for triage.”
The device, which has been in clinical trials in Europe and the U.S., will be submitted for an FDA clearance with the hope that it can be commercialized later this year, Eastman said. If it does get approval, the BodyGuardian will compete with other nonlethal cardiac events and remote physiological monitors like the ones made by San Jose, California-based Corventis.
Meanwhile, Preventice’s move to make hardware has prompted a need for medical device expertise at the company better known for its host of mobile medical apps for prescription medication management, cardiac care, sleep apnea and diabetes management.
The company’s vice president of marketing, Michael Emerson, said by mid-2012, the 35-person company’s ranks will swell to about 50.
What are the positions available? Software engineering, marketing, medical device product development, FDA regulatory expertise and in HIPAA compliance, Emerson said.
[Photo Credit: David Castillo Dominici]