Wearable Medical Devices and New High-Tech Devices Proliferate

The global wearable medical devices market is expected to grow at a compound rate of 18.0% during the period 2015 to 2023, increasing from $2.7 billion in 2014 to $10 billion by the end of 2033. While we do not want to spend more, many of the new wearable devices will deliver better care and curb suffering.

Consumers suffer from chronic conditions such as hypertension, sleep apnea, obesity, hearing loss, diabetes, and other challenges that lead them to treatment or accommodation from wearable medical devices. As well, physicians can now prescribe or implant new high-tech medical devices for their patients. The range of wearable devices has expanded at a fast clip in the last decade.

According to CDC, more than 29 million people in the U.S. are suffering from diabetes, fueling the demand for glucose monitors, heart rate monitors, and activity monitors that account for a significant part of the market for wearable medical devices.

As a result, glucose monitors are now almost a commodity. Americans with diabetes rely on diet and insulin injections to keep their blood glucose level within a safe range. In most drug stores, there is a choice of about 5 glucose monitor models priced near $25 that produce comparable results. They are differentiated mostly by inconvenience and finger-stick pain.

Abbot Labs’ FreeStyle Libre 14-day system requires no painful jabbing of fingers with a lancet. FreeStyle competes against Contour, Accu-Chek, OneTouch, and other metering systems. Some of these systems show the readings and retain them in memory. Others transmit the readings to smartphones or to Internet websites where they can be reviewed by a physician.

In December 2018, Apple Watch Series 4 customers with the latest software could identify atrial fibrillation, a form of irregular heart rhythm by tapping on the crown of their watch. Apple obtained FDA “clearance” for the device following a preclinical study and a clinical trial to ensure that the watch could distinguish between a normal heartbeat and atrial fibrillation. FDA “clearance” can be obtained for devices that are similar to another legally marketed device. Earlier, AliveCor and iRhythm had developed similar electrocardiogram devices. Omron has also released a smartwatch that can measure blood pressure directly from the wrist.

FitBit, once the rage in monitoring personal fitness activity, is popular still. It also tracks your heart rate on a 24/7 basis and estimates your all-day calorie burn.

While Apple Watch, FitBit and FreeStyle Libre 14 are clearly aimed at consumers who lack sophisticated medical training, there are many high-tech devices developed recently that are intended for professional diagnostics and treatments. For example, in 2018, Abbott received FDA approval for its next generation version of the MitraClip heart valve repair device. MitraClip repairs leaky heart valves without open heart surgery – not something you’d try in the kitchen.

In 2018, Stryker’s Surpass Streamline flow diverter for treating certain types of brain aneurysm won FDA pre-market approval (PMA) for large and giant posterior artery aneurysms. If an aneurysm (bulge that thins the wall of an artery) is left untreated, it can rupture and bleed into the space around the brain, creating a dangerous condition. Stryker’s Surpass competes against other newly launched aneurysm devices.

Medtronic’s Guardian Connect continuous glucose monitor (CGM) is launching a “Sugar.IQ” that will recognize patterns in diabetes data and advise the patient on what actions to take. The Sugar.IQ is an AI companion to the Guardian Connect CGM. The Sugar.IQ can give the patient a four-hour advance warning of hypoglycemia. It increases the patients’ glucose time in-range by 33 minutes daily, providing a half hour less damage from diabetes each day.

A patch that replaces the traditional vaccination by syringe is now available. The Nanopatch uses thousands of vaccine coated microprojections that painlessly perforate into the outer layers of the skin and deliver the vaccine. Presumably, this will be welcomed by pediatricians and parents.

Recently the Center for Medicare and Medicaid Services began a more wholehearted endorsement of telemedicine to help patients avoid driving to clinics. Telemedicine and many of the professional use devices will be networked back from patients’ homes to health care providers when 5G gives the convenience and bandwidth to make that possible.

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