Innovations in Vital Signs Monitoring

The growing need for constant health care monitoring and the shortage of trained professionals provides fertile ground for innovation in vital signs monitoring. The sensor and microelectronic technology domains have vibrant innovation ecosystems working toward improving sensitivity, multi-parametric sensing and wireless sensing. Read more in this Frost & Sullivan analysis.

There are several socioeconomic forces in simultaneous action in the United States and in most other Western countries. That the West is aging—and aging fast—is a known fact: it is expected that the population of Americans above the age of 65 will double in the next three decades. The process of aging is accompanied by the need for more and constant health monitoring. Separately, the general lifestyle changes of the last few decades have resulted in a higher incidence of chronic conditions such as diabetes and cardiovascular diseases. And, reforms in the health insurance space have resulted in expanded coverage. All these factors have one fundamental requirement: constant monitoring of health parameters. Here is the catch.

The United States is facing a severe nursing shortage. The Bureau of Labor Statistics estimates that by 2024, the country will face a shortage of at least 1 million nurses. Even today, the estimated 3 million U.S. nurses are unable to adequately staff emergency rooms, surgical centers, clinics and senior homes. This mismatch between the growing need for constant health care monitoring and the shortage of trained professionals provides fertile ground for innovation in vital signs monitoring. The sensor and microelectronic technology domains have vibrant innovation ecosystems working toward improving sensitivity, multi-parametric sensing and wireless sensing. These innovations have had a direct and powerful impact on vital signs monitoring.

Body-Worn Monitoring

In a short period of time, wearable devices have emerged as an important class of consumer electronic devices. Going beyond social media notifications and fitness tracking, most wearable devices have sensor systems that monitor and record vital signs. The Swiss company Biovotion has developed Everion, a clinical-grade health monitoring device that is worn on the arm, serving as an unobtrusive and discreet heart rate monitor. Besides measuring heart rate, which is standard fare for most wearable devices, Everion also monitors heart rate variability, oxygen saturation, blood pulse wave, quality of sleep activity and daily physical activities. Biovotion is working to incorporate noninvasive blood glucose monitoring and other features into the product.

Dexcom, Inc. (San Diego, Calif.) recently won a U.S. Food and Drug Administration (FDA) green light for its new G6 system—a noninvasive, real-time glucose monitor. The G6 system consists of a sensor patch that is worn on the stomach and is paired to a smartphone. The patch continuously measures blood glucose and alerts the patient when it falls below a certain threshold value. G6 is expected to reach the market in the second half of 2018, and is expected to have a big impact on the large and fast-growing diabetes community in the United States. Continuous glucose monitoring eliminates the need for painful finger pricks to periodically test glucose levels, while the discreet stomach patch prevents unwanted attention and the associated social stigma that may arise from a more visible wearable device.

Ingestible Monitoring

Another way of circumventing the issue of awkward gazes and irksome questioning is to entirely internalize the sensing platform. The idea of ingesting a sensor may be a hard pill to swallow for many, but feverish research in this area has raised the market prospects of this technology. In November 2017, the FDA approved the first-ever pharmaceutical pill with an electronic sensor chip embedded in it. The pill, Abilify MyCite, developed by California-based Proteus Digital Health, is actually an FDA-approved drug (aripiprazole) that is used to treat schizophrenia, bipolar disorder and depression. The ingestible event marker (IEM) is a microsensor that is embedded in the pill to monitor whether the patient has indeed ingested it. This is valuable information not just for mental disorder drugs, but also as a safety mechanism to ensure medication adherence and to prevent accidental drug overdose.

A group of researchers led by Kourosh Kalantar-Zadeh at RMIT University (Melbourne, Australia) has developed an ingestible sensor to study the microbiota present in the human gut. By measuring the gaseous and thermal signature in the gut, the group believes it can obtain a more realistic understanding of the digestive tract than through the study and laboratory testing of stool samples. The wireless sensor continuously relays information to a body-worn receiver that is then tethered to a smartphone for further analysis. This success of this sensor platform, which is in very early clinical trials, will definitely have a big impact on the diagnosis of digestive tract disorders.

Noncontact Monitoring

The Holy Grail of vital signs monitoring, or indeed any type of medical diagnosis, is a noncontact way of obtaining information. Sci-fi literature and television shows have fueled our imagination of a magic wand that, if not able to cure diseases, at least diagnoses them without touching the patient. The tricorder made popular in the television series Star Trek has set the standards of product design quite high. In fact, there is an annual competition sponsored by Qualcomm, called the Tricorder XPrize, that encourages enthusiastic young companies and researchers to develop a single portable sensor system that should weigh “no greater than 5 pounds.” This device is expected to wirelessly detect key health metrics and diagnose a panel of 12 health conditions, including anemia, atrial fibrillation, chronic obstructive pulmonary disorder, diabetes and sleep apnea.

Several companies have over the last 5 years won the competition and have used the prize money as seed investment to further develop their ideas. Prominent among the winners is Sunnyvale, Calif.-based Scanadu. Its breakthrough device, Scout, is a wireless vital signs monitor that can detect body temperature, blood pressure, heart rate and oxygen saturation, and display the findings on a smartphone. The device is still in development to obtain regulatory clearance.

The Road Ahead

If a certain degree of training is required to obtain vital signs and that talent is found to be lacking in the United States, the training and expertise required to interpret those results is scarcer still. This is where a certain degree of automation in interpreting the results, and accordingly warning the patients or their caregivers, can come in handy. While the shift from conventional vital signs monitors to wearable, ingestible and noncontact monitors may take several years, what is expected to influence medical diagnoses regardless of the mode of monitoring is the use of artificial intelligence and advanced analytics.

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