Product Creation Studio is pleased to bring you exclusive, on-going content by Heather Thompson, a senior editor for Medical Design & Outsourcing and former editor-in-chief of MD+DI magazine.  With 15 years of experience covering medical technologies and FDA regulations, Heather specializes in delivering the latest trends and news in the medical device industry. 

The global wearable medical device market was valued at approximately $ 6.8 billion in 2017 and is anticipated to reach a value of approximately US$ 29.6 billion by 2026. according to the latest report from Transparency Market Research.

Wearables already touch nearly every corner of the medical and healthcare industry. They are used in diagnostics and continuous monitoring for chronic disease, obstetrics, and natal care. They are used in therapeutics, for pain management, rehabilitation, and respiratory therapy. And they work in all environments, as smart watches, patches, and even clothing. Look for them in sports medicine, wellness, and home healthcare, as well as pharmacies, ORs, and doctors’ offices.

And you’ve surely heard of some of the big products from big names, such as Omron Healthcare’s HeartGuide watch for tracking blood pressure, the Verily Study Watch for population health research and, of course, the ECG features of the latest Apple Watch.

Smaller companies and researchers are also developing wearables. These companies are pushing the boundaries of what is possible and offering new advances in how the products are used. Here are some exciting ways wearables are transforming.  

Tech Clothing

Wearable technology is getting more discreet, to the point of invisibility. Case in point is Kymira Sport, an athletic clothing company. The high-tech athletic wear uses KYnergy technology that is part of the textile and works for the life of the garment.

Kymera harnesses the wearer’s energy and the latent energy in the surroundings and convert it into Far Infrared Radiation (FIR). According to the company, FIR increases the production of nitric oxide and blood circulation to aid in performance, recovery, thermoregulation, and pain relief. The company won the wearable innovation award at the Digital Health and Technology Show, which was held in London in March.

Child’s Play

Even when they are not woven into fabric the size of wearable technology has gotten smaller for critical care applications. Engineers from the University of Irvine, California have developed an inexpensive and easy to use respiration monitor that can both measure the respiration rate and track the volume of air the patient inspires. Two piezo-resistive sensors are attached to the ribs and abdomen to measure the strain on the tissue. The kicker? They use a children’s toy technology to get everything the right size.

Shrinky Dinks are plastic films that shrink when heated. The devices are made by applying a very thin layer of metal to a sheet of the plastic toy and then heat-shrinking it to cause corrugation. The film is then transferred to a soft, stretchy material – similar to small bandage – that can be adhered to a patient. Signals from embedded sensors can be transmitted via Bluetooth to be displayed on a smartphone app.

Measuring the slight electric current produced by the sensors provides an indicator of the strain imposed on them, which has a close correlation to inspiration volume. So far, the team has shown the device works when the patient is at rest or walking around. The technology is not quite ready for the market, but the novel approach makes it worth watching.

Predictive Health Modeling

Spry Health recently won FDA 510(k) clearance for Loop, an at-home chronic obstructive pulmonary disease (COPD) monitor.

 The wristband system remotely measures heart rate, respiration and pulse oximetry. These vital signs are relevant for patients with COPD, because changes in respiration rate and blood oxygen are indicative of a deterioration. 

Spry developed the wearable with an express objective of data generation and predictive analysis among the user population. COPD has known and measurable deterioration signals. Pairing that data with machine learning-driven analysis will help identify patients at the greatest risk.

Spry will be pursuing a B2B commercialization model for its product, with a focus on deals with Medicare Advantage plans, health care organizations, integrated providers, independent physician associations, and other businesses. These organizations have a vested interest in helping high-risk patients before they require hospitalization.

Cancer Smart

Researchers at the University of Michigan are creating a wearable device that can collect live cancer cells from blood. The researchers hope it will diagnose and treat cancer more effectively. 

Dr. Daniel Hayes, professor of breast cancer research at the University of Michigan explained in a press release that cancer cells are typically captured from blood samples from a patient, which is no more than a tablespoon of blood taken in a single draw. The blood sometimes has no cancer cells and blood samples from patients who have advanced cancer might contain no more than 10 cancer cells.

However, a wrist-worn device containing a chip could collect cancer cells on a continuous basis, providing researchers with more cells to determine tumor biology and improve care. Tests have shown that the chip was able to trap 3.5 times as many cancer cells per milliliter of blood compared to other blood draw samples. 

The device incorporates a dose of heparin to prevent clotting, as well as sterilization methods to kill bacteria without damaging cell-targeting immune makers on the chip. The chip itself is made from nonmaterial graphene oxide which can trap more than 80% of cancer cells. The device also includes medical grade pumps packaged in a 3D printed box along with the device’s electronics and the chip.

Researchers tested dogs injected with human cancer cells. The blood cells were eliminated by the dog’s immune system over a few hours with no lasting effects.

Exciting Opportunities

Although big players continue to dominate the wearable space, both small companies and researchers are developing exciting technologies that will inform how wearables advance. These cutting-edge leaders show us the value of wearable technologies with an eye toward the future.