NPI Services Gives Health and Medical Electronics Products a Six-Month Checkup

At the 2014 International Consumer Electronics Show (CES 2014) in January, NPI Services founder Judy Greenspon paid special attention to the many medical, health, and fitness electronics, in part because the latest certification at NPI Services, Inc., ISO 13485, enables production of medical devices in addition to NPI’s long-established history of doing medical device prototypes. Wearing a newly acquired Fitbit® tracker, she logged many miles in Las Vegas, making her rounds though the multiple venues featuring over 3,000 exhibitors. Health tech was a major theme at this year’s show, and “smart everything,” plus a major emphasis on wearables, including an entire section dedicated to the “Wrist Revolution.” Now, six months after the show, here is a check-up on some notable health and medical electronic products, and what’s been happening with them since leaving Las Vegas.

Intel’s booth created a sensation with The Mimo Baby, made by Rest Devices., and “favorited” by Tech Hive and TechCrunch. This baby-monitoring system uses soft cotton “onesie” baby garments with sensor stripes and a “lily-pad” data collector. A separate tracker, in the form of an Intel Edison-chipped soft plastic turtle, is placed on the “lily-pad” of whichever onesie is being worn, and the baby’s metrics (breathing, skin temperature, movements, and body position) are tracked and sent to the parents’ smartphones. (At the CES demo, a Bluetooth-enabled coffee mug received data from the turtle-tracker!) Although more competitors have entered this market, Rest Devices, comprised mainly of a small group of MIT graduates, keeps its competitive edge by creating rapid prototypes using CAD and 3-D printing. They have partnered with Babies”Я”Us to distribute The Mimo Baby products.

Using electrical impedance myography (EIM), developed to measure muscle health in clinical trials of patients with neuromuscular problems such as ALS, maker Convergence Medical Devices became Skulpt Health in 2009, and has developed a consumer product bringing its 21st century EIM technology to fitness buffs aiming to be even more fit and buff! Called Skulpt Aim, the product closed its Indiegogo crowdfunding campaign shortly after CES 2014, achieving nearly four times its $100,000 goal. Pressing Aim against a major muscle yields that muscle’s fat percentage and its index of muscle quality, called a muscle quotient (MQ). Patterned after the familiar IQ, or intelligence quotient, an MQ of 100 indicates normal, adequate muscle fitness. First deliveries to users are scheduled around September 2014. Both the Skulpt Aim and The Mimo Baby exemplify products similar to FDA regulated medical devices, redesigned and repurposed for consumer use. For devices not functioning directly as patient care, the FDA has chosen not to exercise oversight, smoothing the way to market for health electronics.

With its market launch one year ago, Reebok CheckLight, a flexible skullcap with an LED display on a tab extending to the nape of the neck, uses bendable and stretchable electronics made by MC10, the Ryan Lewis to Reebok’s Macklemore for the CheckLight. MC10 is a notable maker of products which employ stretchable circuits for medical, health, consumer, industrial, and defense use. Worn alone or under a helmet, the CheckLight records head impacts experienced, both counting them and estimating their strength. CheckLight uses the same Head Injury Criterion (HIC) as the US National Highway Traffic Safety Administration uses for car safety ratings. The LED display is initially a green light, and depending on the severity of impacts sensed, may change to a yellow warning light, or to a red alert light. Although not a diagnostic tool, this wearable impact monitor alerts coaches and parents that a player may be at risk of injury, or actually injured. Having an indicator light may also help players more calmly accept decisions to pull them out of play. NFL quarterback Matt Hasselbeck has been an advertising spokesperson for Reebok, promoting the device while helping the public understand its purpose, and disclaiming any ability to detect actual head trauma. Reebok CheckLights are currently available for purchase. Teaming with MC10, Reebok, which is historically known for athletic apparel, has clearly been able to meet the demand for its wearable tech.

MUSE: the brain sensing headband by Interaxon, detects brain activity in the five bands typically used to characterize brain waves. Coupled with the app Muse Calm, included with purchase, the users perform a few minutes of daily exercises to practice attaining mental calmness and focus, using biofeedback from the MUSE headband displayed on their computers or smartphones. Worn as a horizontal band across the forehead, extending to the area over and behind the ears, MUSE has seven sensors which require no gel like clinical electrodes. MUSE is another example of medical technology employed for consumer use. At the time of CES 2014, buyers could reserve a MUSE at which now directs the buyer to the current site Potential customers may now expect shipment in North America in 2-3 weeks, or 6-8 weeks, depending on headband color desired.

Without going into detail, other eHealth products exhibited at CES included earbuds that monitor heart rate, a walking tracker for dogs (are you getting your money’s worth from your dogwalker?), sophisticated athletic training aids for all three phases of a triathlon, clinical equipment, and a myriad of monitors and trackers. From the perspective of a provider of services for customers needing prototypes and low-volume production, it became clear that, technologically, a great number of products exhibited were fairly simple compared to many of our customers’ needs. However, great products originate from innovators with diverse capabilities which may or may not include much expertise and experience in the design and fabrication of electronics. For all your electronic prototype and low-volume production needs, you can rely on NPI Services, Inc. to help you bring your next great idea to market. Your prototype or product might just be headed, on time and under budget, for Vegas for CES 2015!