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The growth of the Internet of Things (IoT) for consumer electronics was more than evident this last holiday season. Commercials and print ads for the Smart Home, synonymous with IoT in this market segment, were everywhere. You couldn’t get away from security cameras, door locks, thermostats, lighting control, network addressable plugs, and voice controlled everything. And that is a good thing. It means the promise of IoT is being realized. In the medical market, the promise is still there, but since our lives depend on these devices, the FDA takes a more conservative approval approach. The medical market is divided into three subsets: hospitals, surgical centers, and personal monitors. Each is unique in their adoption of IoT.
The goal of IoT devices in the hospital segment is to provide continuous vital sign assessment which will enhance patient safety. While intensive care patients are continuously monitored, others are periodically monitored, which is why sleep comes in two or three hour allotments in the hospital. It is hoped that continuous vital sign monitoring will initiate nursing interventions that prevent ‘failure-to-rescue’ events. These monitoring devices will be WiFi enabled, allowing access to every patient’s vital signs at a nursing station, or by sending them to a doctor’s smartphone. The false alarm rate must be kept to a minimum, meaning better than the ICU devices they currently have in place. Devices must also be small to allow the patient to be mobile. Products like Masimo’s Root and Solera Wireless’s Visi Mobile are examples of the state of IoT in the hospital market.
Root is a patient monitoring and connectivity platform that includes the Radius-7 wearable device. It monitors oxygen saturation, pulse rate, and respiration. No, you won’t be making a fashion statement with it, especially wearing that gown, but it is definitely mobile. It features both Bluetooth and WiFi interfaces, a 12-hour battery life, and alarms (through the Root platform when in range or directly on the Radius-7 when out of range). It is mounted to an armband that is single-patient-use. Visi Mobile offers a similar suite of monitoring functions but adds additional monitoring of temperature, blood pressure, and electrocardiogram (ECG or EKG) with the use of external, skin-mounted sensors.
It is expensive to develop products for the hospital environment. Regulatory hurdles are significant, so biosensor companies are partnering with health companies, contract manufacturers, component suppliers, and venture capitalists: a complete ecosystem to improve the odds of success. Bottom line, hospitals are evaluating concepts and conducting limited trials in the IoT area.
Ambulatory Surgery Centers
The first surgical center was founded in 1970 to address the long wait times for hospital-based surgeries, the expense of days of recovery in the hospital, and the risk of secondary infections in the hospital. Today there are over 5,500 surgical centers in the U.S., and outpatient surgery represents nearly 70% of all surgery performed. Physicians can tailor the surgical room with equipment they prefer and work with assistant teams that know their methods. Despite the benefits of surgical centers for the patients, these centers get reimbursed by MediCare at roughly half the rate of hospitals, thus demonstrating the power of lobbyists.
Say you have a hip replaced at a surgical center and two hours after surgery you start regaining true consciousness at home in your bed. What IoT products might you have at your bedside? Pretty much nothing. There will be an ice therapy machine you bought or rented. You’ll get a call from the surgeon later in the evening and you will have physical therapy scheduled, but nothing that actually monitors your vitals and makes that data available to the follow-up staff and doctor at the surgical center. A market without a product is another word for opportunity and lots of companies know it. The goal is a “smart bandaid.” Stick it to your hand and it has the electronics to give temperature, oxygen saturation, heart rate, and blood pressure; it’s WiFi enabled and disposable. Companies like Nokia, Qualcomm, Philips, and a slew of startups are all working on this holy grail of markets but it is in a nascent phase. Companies like Masimo are promoting Radius-7 to this market segment as well.
Fitness Bands and Personal Monitors
You can get heart rate, oxygen saturation, and electrocardiogram readings from fitness bands, smart watches, and smartphones. However, fitness bands and other personal monitors won’t be accepted by the clinical community until the data is proven reliable and useful. That said, there are personal monitors that connect to your phone via Bluetooth that are FDA approved, for example, AliveCor’s KardiaMobile measures heart rhythm and detects arterial fibrillation. But wait, there’s more. They have announced a sensor that snaps to the watch band of an Apple Watch that does the same thing and it is also FDA cleared. It’s a non-continuous, patient-triggered event monitor but it does not catch arrhythmias. It is a far cry from a 12-lead ECG but could be useful in some cases.
Companies like Noika, Eli Lilly, Medtronic, Abbott, and hundreds of startups are designing connected devices for measuring glucose, temperature, glaucoma, ECG, asthma, male fertility, sleep patterns, UV exposure, and blood pressure. All are focusing on continuous measurement, portability, intervention, and ease of use. The tools are there, many are FDA approved, and more are on their way.
…now if I could just get up off the couch and exercise it’s likely I wouldn’t need any of these…