The SMART belt (Photo by: Jeff Fitlow/Rice University)
Epilepsy is one medical condition where the constant monitoring capability of a wearable sensor could save lives, providing an early warning when a person with epilepsy has a seizure or even predicting seizures before they happen. Surprisingly, though, it hasn't been an overly popular target for mobile health entrepreneurs. For developers working on this technology, getting to market has proved challenging for various reasons.
Rosalind Picard, a professor at the MIT Media Lab, developed a wristworn sensor to provide an early warning system for children with epilepsy. The discovery was made by accident, when Picard and her team were using the wristbands to study emotional responses in children on the autism spectrum. They discovered that changes in galvanic skin response could predict the onset of seizures.
Picard co-founded sensor company Affectiva to commercialize some of her work with emotion sensing. The device Picard and her student Ming-Zher Poh developed was the basis for Affectiva's Q-Sensor, a commercial device used in a number of epilepsy studies, including one at Boston Children's Hospital.
As of last month, however, Affectiva stopped production of the Q-Sensor, saying they were now focusing on their Affdex facial expression analysis software "in response to strong and growing market demand." Affdex is not a healthcare product, but instead targets its offering at advertisers, who could use expression analysis as part of next generation focus groups.
"Affectiva will discontinue the Q Sensor, as of April 30, 2013," the company said in a press release. "The company will stop taking new device orders after this time, but is committed to supporting all existing customers until April 30, 2014."
Picard is on a sabbatical from MIT and couldn't be reached for comment, but based on her absence from the company's team page, she appears to have split with the company she co-founded.
Rice University's SMART Belt
A team of undergraduate students at Rice University in Texas has created a prototype belt that could potentially detect seizures in children with epilepsy. The belt detects changes in electrical conductivity in skin and respiration, both signs of an oncoming epileptic seizure, using electrodes that rest against the skin. A module on the belt can send a signal to a computer or smartphone via Bluetooth if it detects signs of a seizure.
Affectiva's discontinued Q-sensor
The team, made up of Ethan Leng, Mihir Mongia, Charles Park, Tiffany Varughese and Andrew Wu, calls the system the SMART belt, for Seizure Monitoring and Response Transducer. The project was sponsored by Houston-based Cyberonics, which developed and markets an FDA-cleared therapy for refractory epilepsy.
The developers claim the device works better than a motion sensor, because they say it's less likely to return false positives. It also works best at night, when there aren't many external stimuli that can interfere with the sensor.
"Some of the existing things on the market are vibration monitors, microphones in beds that detect motion and sounds coming from people with epilepsy when they're sleeping. But one flaw with this approach is that they weren't able to detect non-convulsive seizures," Wu told MobiHealthNews. "Using EEG, which is the clinical standard, is also very costly. We want to make ours slightly more affordable, so more people could have access to this sort of technology."
Wu said the team has tested the prototype on healthy people mimicking seizure symptoms by being startled or hyperventilating, but the device still needs to be tested on people with epilepsy. Although the students who took on the project, all seniors, have just graduated, Cyberonics maintains the intellectual property for the belt and it's likely that the recent graduates will continue to develop it with an eye toward commercialization. You can check out a video about the project here.
Wave Technology Group
Back in 2010, MobiHealthNews spoke with Wave Technology Group, a startup working on constant EEG monitoring via a smartphone for patients with epilepsy. In an interview this week, founder and CEO Sam Cinquegrani said the group has continued to work on the technology in the meantime, and the advancement of mobile devices has been very promising. Wave now has a working prototype, and he believes the technology could even be developed to the point where it could predict seizures before they happen.
Cinquegrani said the delay in getting to market is due to a lack of funding, which is in turn a consequence of regulatory and reimbursement uncertainty.
"Our biggest problem right now, and the reason things have slowed down tremendously, is the investment community is very scared of anything that looks like a medical device and anything that's reliant on the current payment model," he told MobiHealthNews. "Investors are saying 'How are you going to get anyone to pay for it?'"
The company's solution may be to move to a different regulatory and reimbursement environment entirely. They're in discussions to take their monitoring product to New Zealand for pilot testing.