Alertness Monitoring Devices Emerge from San Diego

by James Cavuoto, editor

Two new manufacturers of drowsiness detection and monitoring devices have emerged from the North San Diego County area of California, a region known more for its biotechnology firms than neurotechnology device manufacturers. But the two companies are approaching the market in different ways.

The more established manufacturer, Advanced Brain Monitoring Inc. of Carlsbad, CA, has been developing its Drowsiness Monitoring Device for several years. The newer player, Alertness Monitoring Inc., also in Carlsbad, is just beginning to assemble prototype devices. Both firms have amassed intellectual property and a wealth of research data on hardware and software techniques for assessing brain state from EEG data.

The market potential for brain state sensors such as alertness or drowsiness monitors is conceivably great if the many technical, clinical, and user acceptance issues confronting manufacturers can be addressed. There is also great potential for these devices in the diagnosis and treatment of sleep disorders, which affect almost 10 percent of the population.

Both Advanced Brain Monitoring and Alertness Monitoring initially targeted the transportation industry as potential markets for their head-mounted sensors because of the risk of traffic accidents caused by drowsy drivers. There have been several highly publicized bus accidents in the last year alone that are believed to have been caused by driver fatigue. But both firms received a frosty reception from truck drivers and their unions who are not too eager to wear headgear, especially the type that makes management privy to their mental state.

ABM’s drowsiness monitoring device is housed in a baseball cap and includes two electrodes that pick up EEG signals from the appropriate place on the scalp. EEG data is transmitted by radio frequency signals to a processor/analyzer located within 20 feet of the user. But the electrodes require a small amount of conductive gel, which makes the headgear even less appealing to truck drivers.

Alertness Monitoring claims to have developed a reliable dry electrode for its BioAlert device that can be worn with very minimal intrusion to the user, and so that company is pursuing the transportation market despite truck driver attitudes. Company president Dr. Richard Levin contends that his device could be configured so that drivers would be alerted before drowsiness sets in without management having access to the data.

But ABM is downplaying the truck driver market, choosing to position its device as a diagnostic tool to be used during physical exams. The U.S. Department of Transportation currently requires the 9 million commercial bus and truck drivers to undergo a fitness for duty physical at time of hire and every two years thereafter. Sleep apnea is one of the conditions that physicians performing the physical must screen for. ABM is also looking at night-shift workers, security guards, and military personnel as market segments.

Both ABM and Alertness Monitoring use algorithms to detect the onset of drowsiness. Richard Levin’s patent, awarded in December 2000, uses the ratio of alpha to beta wave present in the EEG signal to detect drowsiness. The company is working with J&J Engineering, a Poulsbo, WA manufacturer of physiologic monitoring equipment, to develop a working prototype. Levin says he thinks the devices could sell for as low as $250.

ABM’s drowsiness monitoring device currently sells for about $500, although company president Chris Berka says that price could drop with sufficient production volume. The company has developed an “EEG neuro-severity index” to help quantify levels of vigilance and attention based on prior data. Besides the sensor headset, ABM markets a range of assessment software and a sleep apnea risk evaluation system that it hopes will be an alternative to polysomnography diagnoses performed at an overnight sleep laboratory.

ABM was founded in 1997 by Berka and Daniel Levendowski. The pair worked together previously at Psychemedics Corp., a forensic company with a product to identify usage of drugs. ABM has received over $3.2 million in SBIR funds from the National Institutes of Health. The company is currently looking for equity financing to fund beta site testing, market development, and product launch.

Alertness Monitoring was founded in 2001 by Richard Levin, a physician with research experience in neuroscience. That firm is also looking for funding sources and is currently in discussion with nearby SAIC Corp.