• by Bruce Carlson
  • November 9 2016


Second-Generation Wearables Hit the Marketplace

Second-Generation Wearables Hit the Marketplace

The market for wearable medical devices is undergoing intense growth. Wearable devices are no longer just focusing on one measurement such as the number of steps taken in a day but are focusing on a variety of bodily measurements such as heart rate, breathing, blood pressure and many others. Advances in wearable medical devices include new miniaturized sensors; peripherals; real-time measurements and interactions, wireless communication, sort and analyze features, portability and data transfer capabilities. To reach full potential, wearable medical technology has to cross the boundary from consumer electronic devices to regulated medical devices.  Kalorama has covered this market in a recent report on the topic.   Kalorama's report,  the Market for Wearable Devices can be found at: http://www.kaloramainformation.com/Wearable-Devices-10376869/.

This, however, has not been an easy road to navigate for companies that have not specialized in medical equipment previously. The regulatory framework that exists has proved to be quite challenging for many start-ups; as a consequence, wellness tracking devices have proliferated even though these devices monitor bodily functions. To help meet this need for easier regulation, the FDA recently announced smart regulation with more oversight directed to technology that represents high risk to patients and scaling back from the traditional approach.

There is a fine line between wellness and regulated medical devices. In July 2016, the FDA published a guidance document on General Wellness: Policy for Low Risk Devices. For wearable wellness devices, the document outlines two different categories:
• Those that do not make reference to diseases or conditions. These would include claims related to weight management, physical fitness, relaxation, stress management, mental acuity, self-esteem, sleep management, and sexual function.
• Those that make reference to diseases and conditions but only do so in two specific ways. They claim to help users reduce the risk of certain chronic diseases or conditions and they may help users better live with specific chronic diseases or conditions.

Beyond the promotion of general wellness, the continued advancement in technology and the offering of products to various demographics is taking wearables beyond functions associated with a general state of health. Use of wearable medical devices can improve care delivery and patient outcomes, reduce mortality rates, reduce hospital admissions, and result in more efficient use of healthcare resources.

The diagnostic and monitoring devices segment of the wearables market consists of devices that are non-invasive but provide valuable health information. These devices may monitor conditions related to cardiovascular and neurological health, sleep, glucose levels, as well as pregnancy, obstetrics, fetal and infant health. This segment of wearable medical devices represents an exciting opportunity for industry participants. The FDA has approved multiple devices in this area:


• the Withings Blood Pressure Monitor is a wearable blood pressure cuff that measures blood pressure and heart rate. The product is FDA cleared and is compliant with European medical device regulations.
• the WaveSense Blood Glucose Meter by AgaMatrix was the first FDA-cleared blood glucose monitor to connect directly to the iPhone and it provides estimated hemoglobin A1c values as well.
• the Animas Vibe by Animas, a division of Johnson & Johnson, is an insulin pump designed to provide insulin to precisely match with food intake and correct high blood sugar readings. In December 2014, Animas received FDA approval for its Animas Vibe insulin pump with the DexCom G-4 continuous glucose monitoring (CGM) system. The device is waterproof up to 12 feet and is the first and only CGM enabled insulin pump.
• the FDA approved Lifewatch’s Vital Signs Patch (VSP) in October 2014. This technology includes a sensor worn on a patient's upper chest to be used a continuous, non-invasive monitoring system. The sensor is capable of monitoring ECG, heart rate, respiration rate, surface temperature, and arterial blood oxygen saturation. The company announced approval in January 2016 for its MCT1-Lead patch and its wireless, vital signs monitoring patch in the U.S.
• OSI Systems’ Sidestream Capnography Pod, approved by the FDA in August 2012, offers a gas analyzer compatible module with the company's new patient monitor, qube.

Fueled by an aging population with increasing healthcare needs, the expanding use and need of outpatient care, advancing wireless technology capabilities, a continuing nursing shortage, rural health demands, and ever-diminishing healthcare resources, the market for regulated medical devices has not just the potential for growth – it must grow.