Words fail us when we begin to describe the concept of wearable mobile medical devices.  Going back to the bad old days, it could mean backpack sized devices for monitoring and reporting cardiac information like blood pressure, blood sugar, and digestive functions.  A little later on, with the advent of then – new RF technology, LifeAlert made the term “Help, I’ve fallen and I can’t get up!” a part of the modern lexicon, and the source of endless jokes for Baby Boomers.  How the times change…

In the past 5 years, with the advent of the smart phones, ubiquitous WiFi and a world of connected devices and myriad form factors, we find ourselves in a very different place.  There are over 20,000 medically-related applications available on the iOS Webstore alone, covering the waterfront from acne cures (nope, they don’t work) to blood oxygen meters to blood glucose level monitoring.   There are also a wide range of smartphone applications that seek to encourage healthy lifestyles through rewards and incentives, badges and gamification.   In-patient monitoring has also benefitted, freeing patients from their rooms and wired devices.

With less than 10 years of research and development and experience with wearable medical devices, we are surely at the beginning of a long and beneficial road to building a connected world that has at its center the human condition – in health maintenance, in medical treatment, in chronic health condition management.

For better or worse, blogger Kevin Pho, MD, who documents digital trends in medicine, has identified three key areas for mobile medical devices:

Patient In-Home Monitoring

LifeAlert, LifeFone, LifeStation, Alert1,  and other home monitoring devices have been available since the ‘80’’s. Originally these were RF-linked analog devices that placed an analog phone call to a designated emergency service operator, monitoring service or a designated phone number.  These often included a pendant or wristband to keep the emergency device near the patient.

With increased penetration of cellular service, devices like and LifeGuardian have been enhanced with full cellular connectivity similar to GM’s OnStar service.  In addition to pre-loaded emergency contact numbers, the LifeGuardian features a GPS tracker and a patient “fall monitor” that uses an accelerometer.   The LifeGuardian enables a significantly wider range of motion and more information for outside of home.

One of the most compelling products introduced in 2012 is Live!y.   Its product, which will launch in the second quarter of 2013, uses data collected from inexpensive sensors (RFID) affixed to home items such as refrigerators, utensil drawers, and glass cabinets, as well as a key fob (GPS) that detects when the occupant has gone out of range of the house, to create an algorithm that alerts family members or neighbors when it detects abnormal patterns that might signal illness or depression.

The brilliance of this product is in its use of social media and psychology. Knowing that the product’s success lies in the willing participation of seniors, Live!y uses a “give to get” model, where a network of family members is created by the user or their family members.  Younger family members are pinged every week or two to share updates about their lives. Seniors are snail-mailed a printed biweekly family newsletter — fusing old and new technology to solve the difficult challenge of connecting the modern multigenerational family.

Sport, Witness, and Well-being Devices

A hit at the 2013 CES in a follow-up to a strong year for fitness start-ups, sporting goods companies like Nike (Nike FuelBand) and start-up technology manufacturers like BodyMedia and FitBit presented an array of devices that are oriented toward those who are interested in monitoring their bodies’ performance or achieving health-oriented goals.

They encompass several variations on the monitoring theme, but many feature the development of a strategy and plan for achieving a goal, such as losing weight or managing blood glucose levels.   Examples included cardio monitors, intelligent scales, sleep monitors and integrated iOS weight loss ecosystems, all presumably interesting to people motivated to maintain and improve their current good health habits.  But do people really take advantage of the devices as designed?  We’ll get to that later…

The BodyMedia ecosystem is particularly interesting, as it consists of a sophisticated worn monitor and a wide variety of applications that enable a buyer/wearer to fine-tune their experience with the BodyMedia system/device.   The BodyMedia monitor has been promoted on TV’s Biggest Loser, and is popular for its ability to calculate calories burned through a combination of readings, including pulse rate, blood pressure, body temperature and temperature flux rates.   It also interfaces with a wide variety of other software tools and apps, many developed by 3rd parties, giving BodyMedia the distinction of being a platform with published SDK.  With growing influence gained through agreements made with hardware makers, other software publishers, and gamification/incentive/reward suppliers, BodyMedia has the potential to be the “Big Dog” in wearable well-being systems.

At the other end of the spectrum for wearable devices are tools and applications for managing chronic health conditions, like diabetes, atrial fibrillation, and clinical obesity.   Health plans and health providers increasingly recognize the value that worn devices and apps can bring to managing chronic illnesses such as diabetes.

= Withings, in addition to its Wi-Fi Body Scale, also makes a blood pressure monitor that synchs with iOS devices and can share readings with the Microsoft Health Vault and other partners.  By sharing patient health data over a secure network, Withings is helping to enable some of the reporting criteria mandated in the Affordable Care Act.

Massively disruptive changes are underway with the implementation of the Affordable Care Act (ACA), including mandates to implement electronic medical recordkeeping (EMR) and electronic health recordkeeping (EHR), with much data to be collected by wearable medical devices.  A significant next step will be the analysis of the incoming patient data to provide a basis for assessing effective treatments and courses of care for chronic medical conditions.  It will also add to the growing foundation for enabling predictive analytics that can help with evaluation of care quality, effective expenditures of care dollars, and trends in patient health management and outcomes.

Much additional information about wearable medical monitoring devices can be found at Information Week HealthCare, which covers both health and wellness devices and health monitoring.   Information about the Affordable Care Act and EMR/EHR can be found at the Centers for Medicare & Medicaid Services.

Remote In- Patient Monitoring

Hospital telemetry has existed for many years, in what is likely one of the earliest M2M applications.  Using largely hard-wired systems to monitor patients in coronary care units, intensive care units, burn units and similar, telemetry enabled monitoring of multiple systems at work in these settings.   Blood oxygen levels, heart rate, respiration, temp, kidney function, urine output, all are examples of monitored vital signs.   Many of these feedback systems were developed by the medical equipment manufacturers and did not offer common standards for data collection and reporting.

As telemetry has evolved, it has come to rely largely on secure mobile WiFi networks that have revolutionized ambulatory in-patient treatment options.   Philips IntelliVue uses a locked-down Apple iPhone running the proprietary Intellivue application to collect vital patient information, and provides a fully interactive link with the Intellivue monitoring and management control systems.  This can be networked to the hospital EMR application for further analysis


Attribution: Apocolyptik

There is an enormous opportunity in the development and deployment of mobile medical devices and the development of networks to collect and convey vital patient data.  The implementation of the Affordable Care Act (ACA) and the provisions within are driving massive investment in creating tools that will support patient involvement in management of chronic conditions and long-term care.  These same tools are also giving rise to massive amounts of data that can be mined to develop insights about health care delivery and expenditures, and can be linked to create a knowledge framework for better understanding of health care delivery in the U.S.

In the next installment, I will explore the regulatory environment that is driving adoption of mobile medical devices, and the opportunities for a cohesive, integrated approach to answering the question of getting more and better care out of our healthcare dollars.  Stay tuned…

Original Author: Jeremy Eckhous