Last year’s wearable-technology market was valued at just over $13.2 billion, according to healthcare research firm Kalorama Information, a division of Market Research Group LLC in Rockville, Md. That’s projected to triple by 2020.
Local companies Cercacor Laboratories Inc., Microsemi Corp. and Nirrax Light Therapeutics Inc., the newly launched medical business of Nature Bright Co., which makes mood-enhancing light products, have responded with their own versions of patient-centered wearables. The technology is designed to bring care to the patient rather than the patient visiting a hospital.
The concept of monitoring patients outside of hospital settings isn’t new. The Holter Monitor, which weighed 85 pounds, was introduced in 1947 to measure electrical activity in the heart.
Today’s medical devices are considerably smaller and more mobile. They’ve also become more intertwined with the search for value, which calls for alternatives for providers to interact with and monitor patients, perform tests, collect data and deliver treatment.
Personal Health in Spotlight
The notion of being monitored by a digital device is becoming more common, and thanks to the popularity of fitness trackers like Fitbit and Jawbone, devices that monitor physical activity and personal health are increasingly converging, blurring the lines between medical devices and lifestyle devices.
Consumer technology research and consulting firm Park Associates in Dallas, Texas, says that more than 33% of U.S. broadband households owned at least one connected health device last year, up from 25% in 2014.
Irvine-based Cercacor is entering the arena with Ember, a lightweight, noninvasive device that measures the concentration of hemoglobin using advanced LED technology.
“We eventually want to reach the mass, but we are starting our target group with endurance athletes because they understand the importance of monitoring hemoglobin to improve performance,” said Greg Olsen, director of industrial design and user experience at Cercacor.
Hemoglobin is the protein in red blood cells that’s responsible for delivering oxygen to tissues, and trained athletes, particularly in endurance sports, monitor its concentration. Oxygen fuels muscles, enabling them to perform aerobic exercise; it also plays a big role in the recovery process.
One way for endurance athletes to improve their performance is through high-altitude training, where the air is much thinner and their bodies have to work harder. Cercacor said it discovered during design research before creating Ember that many athletes said they had participated in programs that are the same in duration and approaches for all athletes—those programs were not individualized for each athlete’s unique response.
Barriers to personalize training include accessibility to monitoring.
Olsen said the only way athletes can monitor their red cell blood count is for blood to be drawn and sent to a lab. “There is no effective way for athletes and coaches to know what is going on with the body,” Olsen said. “If you go to a lab four times a year, and three times your oxygen level is low, that doesn’t mean anything. You can’t do anything with that information. The value of Ember is that it can provide a way to measure data on a daily basis and track that measurement over time.”
Ember models include the Ember Sport and Ember Sport Premium, which retail for $399 and $699. The basic model measures hemoglobin, pulse rate and perfusion index, and can be upgraded to include four other biomarkers.
Cercacor has hired cyclist Dotsie Bausch as strategist and ambassador manager. The Olympic silver medalist from the 2012 London Games is a seven-time U.S. national champion and two-time Pan American gold medal winner. There are seven Cercacor ambassadors altogether.
Irvine-based Masimo Corp. spun off Cercacor in 1998. Pursuant to a cross-licensing agreement between the parties, Masimo paid Cercacor $6.4 million in royalties for fiscal 2016. Joe Kiani serves as chairman and chief executive of both companies.
Next-Gen Hearing Aids
Chipmaker Microsemi, which primarily serves the aerospace and defense, communications, data center and industrial markets, also maintains a healthcare portfolio. The segment, which includes imaging and diagnostic devices; implantable pacemakers, defibrillators and neurostimulators; and wireless wearables, makes up only a small part of its business, but the Aliso Viejo-based company said it plans to increase sales three-fold when it launches the Hummingbird chip for use in the making of hearing aids.
“The available market today of hearing aids is not very high performance, from surveys we have seen,” said Jim Aralis, chief technology officer and vice president of research and development and engineering.
A hearing aid, at the most basic level, is just a microphone and an amplifier in the ear, but he said there’s more to hearing.
“People are unsatisfied with performance. Dumb hearing aids just amplify everything,” he explained. “But people lose their hearing in different ways. Some people can hear high frequency, some people low frequency, so you need to take that person’s hearing and adjust [the device] to help them hear what they can’t hear, making [it] fairly natural.”
He said another challenge to hearing aids is battery life and that the chip will allow optimization of Microsemi’s transceivers to achieve the lowest power consumption in wireless models.
“It uses ultra-low power, the lowest Bluetooth power in the world, [achieves power saving] by about 50%, and extends battery life two times,” Aralis said. A standard hearing aid battery lasts three to 22 days.
Another benefit to incorporating Bluetooth into hearing aids is ease of customization. “Everybody’s phone already has Bluetooth in it,” he said. “You can program and configure [hearing aid settings] from your phone.”
Aralis pointed out that pricing presents a challenge to wide adoption. The difference between high-end and low-end hearing aids can be as much as five to one, Microsemi being in the former market. High-end hearing devices can cost over $3,000 per ear.
He said there’s a strong market for advanced hearing features, including in the military, industrial and earphone and headphone markets. Features like higher processing speed, voice isolation, sound-direction isolation, glass-breaking and gunshot sound recognition have industrial and military applications.
As for earphones and headphones, there’s growing similarity between those and hearing aids.
“We are working with a headphone maker who told us there will be no difference between your hearing aids and earphones, headphones in the future,” Aralis said. “You can use the device to control things like answering your phone, playing music … sound and voice isolation.”
The Hummingbird chip will be available next year. “The intention is to grow [that business] like everything in our business,” Aralis said.
Heart on Your Sleeve
Joshua Chen, chief executive of Irvine-based Nature Bright and another new medical company, Nirrax, said he wants his products to be truly wearable, along the lines of garments.
“Most medical wearables today wear like a medical device. They are smaller, with better technology, but they are literally a device secured with straps, buckles or bands,” Chen said. “The type of wearable that I will be launching can be worn anywhere, anytime.”
Nirrax is working to use low levels of near-infrared light to treat a wide range of brain disorders.
Chen said Nirrax can offer more effective therapeutic benefits because the product can be worn anytime. He said the company is thinking of starting with headbands, because therapy can be directly applied at the site of brain conditions. The wearable technology will be made from washable fabric and include a wireless charger and control. Chen said the device is designed to be accessible. “I want people to easily access this technology. It will be very easy to understand, to use, and can be purchased at an affordable price point.”
One brief exposure of people or animals to near-infrared light “can have surprisingly long-lasting effects” of days or weeks,” wrote Michael Hamblin, an associate professor at Harvard Medical School and principal investigator at the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston. He noted that tested clinical applications of what’s known as photobiomodulation therapy include wound healing, pain and inflammation reduction, and brain injury therapy.
Nirrax is pursuing the following indications: depression, anxiety, sexual dysfunction and pain management for adults, as well as Down syndrome and autism in children. The depression indication, for which it’s completed a phase one trial, is in line to start commercialization late next year. Products would be manufactured in Europe, and initial commercialization would be in North America.
Chen referenced a pilot study conducted by Massachusetts General Hospital of 14 patients with major depression and anxiety administered a single 810 nanometers LED treatment to the forehead at two locations for four minutes, resulting in improved patient condition after two weeks, though at four weeks, symptoms had begun to reappear.
Chen said that using light to stimulate the brain beats having to spend over $4,000 a year per patient on psychiatric drugs, such as antidepressants and anxiolytics. The actual market spending is estimated at about $150 billion annually on direct medical costs—therapy, drugs, hospitalization and so forth—for an estimated 11.5 million Americans, he added.
“Light mimicking … natural light can help with chronic depression and [seasonal affective disorder],” said Chen, referring to the LED lights sold through Nature Bright. He said he’s treating brain conditions with two type of lights: Nature Bright’s mood-enhancing visible light and Nirrax’ invisible infrared light.
Nature Bright, founded in 2001, has seven full-time employees and generated $3.5 million in revenue last year. Its products can be purchased online or via retailers like Walmart and Target.
Nature Bright started 17 years ago with visible light consumer products, such as LED lights to treat seasonal effective disorder.
