Wearable technology is becoming increasingly popular for health-conscious consumers. Accurate measurements of key health metrics such as blood pressure and cardiac fitness would drive further growth in the field, but these goals remain somewhat elusive.
 
Valencell, a Raleigh, NC-based biometric sensor technology specialist, is changing that. Valencell already has its heart rate and other sensors in the marketplace in products ranging from earbuds to fitness bands, and the company sees strong opportunities ahead for bringing together health care and wearable specialists to meet the increasing demand for healthcare data.
 
“There is a trend toward patient generated data being gathered 24/7,” Ryan Kraudel, VP of marketing for Valencell, said. “Wearable companies and medical device companies are going after this opportunity. Medical device companies recognize the opportunity to gather data from people outside of a medical facility and they know all about the levels of accuracy needed, but they don’t necessarily know how to make something that people would want to wear on a 24/7 basis. The wearables guys know how to make something people want to wear, but they don’t generally have the level of accuracy. You have these two segments going after this opportunity, and Valencell is well positioned to enable both these segments to support this interest in patient generated data.”
 
Valencell is well entrenched in the sensor field, with 16 different products on the market today, including products from Bose, LG, Jabra, Sony, Scosche, mid-sized and small companies as well. In addition, Samsung has licensed Valencell’s patented PerformTek portfolio for use in hearable devices, including the Samsung Gear IconX cord-free fitness earbuds.
 
Kraudel noted that the company has been around for 10 years, before wearables even existed, before FitBit and Apple Watch.
 
“Our company developed technology for the wearables we see today,” Kraudel observed. “We have seen the challenges of integrating this technology into different form factors and use applications. To overcome that, it takes hardware, software and testing.”
 
Valencell places major emphasis on testing, having set up a testing lab in its headquarters to test a variety of new technologies on a pool of 100 volunteers on a weekly basis. Kraudel said it allows Valencell to identify the challenges the technology is having on different types of people.
 
“Our customers work with us not just for the technology but for the expertise and experience we bring in integrating our technology,” he added. “It’s fairly easy to put a couple of LEDs and a photodetector into a wearable device, but actually making it work on a wide range of people is a whole different issue. It has to interact with the human body, and everyone is different.
 
“In the healthcare and consumer wearables spaces, people are starting to recognize that accuracy does really matter,” Kraudel noted. “These devices give insights into overall health and fitness levels. If the data coming off the wearable device is not accurate, then the advice is not accurate, and the consumer will lose trust. It leads to problems with the overall user experience and people returning the devices.”
 
The hardware and software aspects of these sensors are challenging, but Kraudel said that Valencell has designed its technology for accuracy.
 
“A lot of our hardware IP is built around optomechanical designs themselves, and how that light is guided into the skin to make sure the signal that comes off the sensor is as clean as it can be,” Kraudel noted. “Of all of the signals coming into the photodetector, less than 1% is from the blood flow. The LEDs shine light into the body and measure how much is reflected back due to the blood flow. How the optomechanics are designed and the LEDs are placed are significant considerations.
 
“For our software side, the signal processing algorithms turn the signal into biometric readings like heart rate.”
 
“We already have VO2 and VO2 max, which is a measure of someone’s overall cardiac fitness level, as well as other cardiac fitness testing, such as cardiac efficiency,” he added. “We also have a metric that is called RR interval, which is used to measure hart rate variability, the time between heart beats that can have clinically validated implications both from a fitness level such as overtraining or undertraining, and also very real implications in health conditions such as atrial fib and arrhythmia.”
 
Aside from testing the wearables on people, there is also quality control work being done on manufacturing lines.
 
“There is also testing these devices once they come off of manufacturing,” Kraudel pointed out. “It is very different testing an optical device from a watch. We make our own testing device that tests each device as it comes off of the line to make sure each one matches the results we got in the lab.”
 
Blood pressure is a key test that is lacking from wearables, and Valencell is closing in on this measurement.
 
“We are working on blood pressure right now, and will have a live demonstration of the technology at CES 2017,” Kraudel said. “We already have the technology to the level of accuracy that is on par with consumer grade blood cuffs.”
 
Achieving FDA clearance is one key for wearable manufacturers.
 
“We are seeing interest in blood pressure sensors on the back of mobile phones, but the mobile phone companies have no interest in going through the FDA process,” Kraudel noted. “Companies that are comfortable with the FDA will go through the process, while others who do not want to go down that path will use the technology to make indicative measures but not make a medical claim.”
 
Because these products usually have longer life cycles, Valencell already has new products lined up for the coming year.
 
“Being an ingredients company, we get involved in product life cycles 12 to 18 months before it comes to market,” Kraudel said. “We will see more of our technology come to market in 2017. We are in a good position as an ingredient technology.”