Medical Smartwatch as Health Diagnostic Device

Xavier Yagual, Abdel Ghoneim, Emma Athow, Yauheni Patapau

English 21007

Professor von Uhl

City College of New York

Summary

Currently, heart disease is the reigning cause of death in the United States, averaging in about 610,000 deaths every year (Advisory, 2018).  Heart disease has been the number one cause of death since 1921 (CDC, 2018).  Will we let it hold its title for a whole century, or can we dethrone heart disease?

In contemporary society, smartwatches are one of the top wearable devices available. This year, eMarketer expects over 60 million people in the United States alone to have a smartwatch (CDC, 2018).  Major companies like Apple, Samsung, Fitbit, Fossil, Withings, and Verizon have all produced their version of the smartwatch.  Together these devices can measure the activity, exercise, heart rate, food, weight and sleep of its user.  However, none of these devices are able to track the blood pressure, heart rate and better manage chronic diseases like diabetes in users.

We propose a Medical Smartwatch that can function as a portable electrocardiogram (ECG), can measure blood pressure and can oversee diabetes and other chronic diseases. To add to that, the watch can notify family members, friends, doctors, or 911 if the user has an irregular heartbeat or reason for hospitalization. The budget for this innovation would be at most $100,000 for research and development.

Introduction 

Sudden cardiac arrest occurs when the heart suddenly stops beating, which stops oxygen-rich blood from reaching the brain and other organs. A heart attack occurs when a coronary artery becomes suddenly blocked, stopping the flow of blood to the heart muscle and damaging it. According to the CDC, heart disease is the leading cause of death for both men and women. More than half of the deaths due to heart disease in 2009 were in men (CDC,2018). The purpose of our medical smartwatch is to aid in the detection of increasing risk factors that can lead to diseases or even death. The watch will include an ECG sensor to monitor blood pressure as well as alerting the user, doctor, and family of any irregularities. The optical pulse sensor will aid in the detection of chronic diseases such as diabetes. As for the scope of our proposal, we will accomplish the creation of a medical smartwatch that includes modern technology in one compact device that is easily usable and accessible. On the other hand, as for what we will not accomplish is the further advancement of today’s technology, rather we are bringing them together in one device. Our proposal is organized by the introduction of the three technology we will include in our watch. Next, we look at the technology within the Apple watch that is used around the world and recommended by many. Finally, we take the necessary sensors from the technology used and the user-friendly aspects of the Apple watch to create our innovation.

Proposed Program

Since a large percentage of the population deals with the aforementioned diseases, we propose a way to predict and in doing so prevent these diseases. Many people are at risk whether it be to heart disease, diabetes, and other chronic diseases, or blood pressure related disease. Our fully functioning medical watch serves to accurately detect any risks within the individual to prevent these diseases and a lifetime of suffering. The watch comes with four features that distinguish it as a medical watch. It includes an ECG sensor, a blood pressure monitor, a newly developed optical sensor as well as the typical communication feature that comes standard with today’s smartwatches. All these come together in a new, easily accessible, and convenient, one of a kind medical smartwatch.

The ECG sensor was developed by Alivecor in a smartwatch they labeled as the “Kardia Band.” This device includes a band with a smartwatch and the ECG metallic sensor on the strap of the watch (Bumgarner, 2018). This band is paired with an application as part of the smartwatch to find abnormalities in the heart of the person taking the test.

There are two components of this new Kardia Band.  There are the smartwatch and the sensor cutout from the band as seen in Figure 1.  The Alivecor company managed to incorporate a tiny CR1620 battery that can last two years, the electronics for the sensor, and the hardware to send results to the watch and smartphone (Jung, 2018).

The individual taking the ECG test places their thumb on the sensor and a pulse is sent out through both arms to connect with the heart. This is a Lead I ECG where it connects the right and left arms. A standard ECG is 12 Lead which makes it more accurate as it takes a full body measure (ECG, n.d.). The watch then analyses the results and determines if there are irregularities. It is not intended for a full diagnosis but detecting these irregularities is the first step to ensuring a person’s safety (Alivecor, 2014). The sensor from this watch will be incorporated in our medical watch and will be placed on the band of the watch as seen in Figure 1.

The blood pressure monitor was just recently incorporated into a smartwatch by Omron. This company is known for its portable blood pressure monitors and now they took it one step further by making a smartwatch with a blood pressure monitoring feature (Omron, 2019).

The watch is relatively new so it required a lot of technical handling to get the most accurate results. It has to be attached tightly to the wrist and raised to heart level for the most accurate result. It has a monitor with three buttons on the side to control it. It has a cuff used for the test which is separate from the band that straps around the wrist. Once the test starts the watch vibrates once before the cuff starts to inflate. Once the test is done it deflates and saves the results (Heartguide, 2019). This technology is important for our medical watch as it can save time and money from doctors’ visits to take a blood pressure test.

This figure shows tiny optical sensors combined with tiny nanostructures and semiconductors. This is a never before seen piece of technology that has not yet been implemented into a wearable device. It is 50 times thinner than a human hair, can fit anywhere and opens up a whole new world of diagnosing diseases in real time. The way the sensors work is by measuring small concentrations of metabolites which a person emits naturally through their skin and breath. Professor Antonio Tricoli said: “These ultra-small sensors could be integrated into a watch to literally provide a window on our health” (Ndivya, 2018).  That is what we plan to do with this new technology. These optical sensors can also help to manage current chronic diseases such as diabetes (Ndivya, 2018). By placing it in a watch along with the other pieces of technology we would get a much fuller view of the human body and diagnose and prevent diseases before they cause any harm.

The medical watch we propose is based on the Apple Watch Series 4. All the major technical components for the watch to run and function efficiently can be found in this watch. After incorporating our new medical technology into this smartwatch and removing any excess we do not need, we will have our new medical smartwatch capable of detecting a multitude of diseases.

This new watch has the display, the battery, the taptic engine, the speaker, the S4 core, and the ECG sensor on the bottom. The display is the way a person interacts with the device. The battery is rechargeable and powers the watch. The taptic engine is responsible for all the vibrations and notifications that you feel. The speaker gives the device sound. The S4 core is what contains the hardware for the functionality of the device. In it are the internet, GPS, and Bluetooth hardware. The ECG sensor is on the back which makes for contact with the skin so the ECG test can function (IFixit, 2018). This is a great device but not the most ideal setup for a medical watch.

Our proposed medical watch will have the same rectangular display like the Apple Watch Series 4. The ECG sensor would be moved back to where it was on the Kardia Band, which is on the band, because we need to make room for the blood pressure monitor. The cuff on the back of the blood pressure monitor would be attached to the back of the medical watch. The new optical sensor would be inside the watch as it is so small it would fit anywhere. The internet, Bluetooth, and GPS connectivity would remain as this provides a way to communicate to family, friends, doctors and the authorities if something were to happen the person wearing the watch. The same goes for the speaker and taptic engine as the speaker makes communication easier and the taptic engine can give signals and an overall sense of functionality.

Innovation Process

Components and Their Costs

Estimated costs of the major components based on the prices of existing fitness bands, trackers, smartwatches and newly developed technologies implemented into our Medical Smartwatch (MacRumors, 2015):

• Display/Touchscreen – $15-$20
• Apps Processor – $10-$12
• Memory (RAM & Flash) – $5-$8
• Bluetooth (BT)/wireless local area network (WLAN) – $2-$3
• User Interface (Audio Codec, Audio Power Amplifier and Other) – $3-$5
• Sensors (Optical Pulse, ECG, Ambient Light sensor, Accelerometer/Gyroscope) – $25-$50
• Blood Pressure Monitor – $20-$25
• Battery – $1
• Other Printed Circuit Boards (PCB), Wristband, Enclosure, Switches, Misc – $10-$16
• Charger, Carrying Case, Packaging – $9

Build Costs

The price of the research and development of a single prototype and creating an operating system with applications might go up to $100,000 and even higher. While the components itself are not expensive, the circuit design/layout and compilation of them into one solid device that has all modules working together might take a lot of time and resources to develop the finished project. It is a rough approximation, but as a new product on the market that includes new technologies of health analysis, it is hard to get an exact cost number. As for the manufacturing price, it could be as cheap as $5 per piece (Stewart, 2018). Today, such countries as China or India can provide the most low-cost labor in the world. Various manufacturing companies in these countries can offer huge production facilities, create any required component for a smartwatch and assemble everything together.

Time

Despite the fact that most of the components that we want to include into our device already exist and there is no need to develop them from a scratch we still creating a new device and it will take more than a year to manufacture and release the project. The R&D process will require a lot of time to implement the connection and synergy among all modules, so that all acquired data from a person can be shared between every part of the device. For example, according to some insiders, the first Apple Watch development started in February 2013, while it was first announced in September 2014 (Williams, 2015). So, it took them approximately 20 months to create the smartwatch. Thus, the designing of our single demo version could take around 6 months, and other work including legal and mass manufacturing arrangements may take 20 months or more. In addition, it will also take approximately 12 months to create an operating system and applications to make our new device run the processes of measuring body data and analyze it. As for obtaining the pieces of technologies for a prototype, it can be done in a month because today’s market is filled with a huge number of electric technology manufacturers that can immediately provide with any part we need.

Appendices

There has been a lot of progress in the health-technology community. For example, smartwatches like the Apple Watch and the Fitbit Versa are able to measure the activity, exercise, heart rate, food, weight and sleep of its user. However, there has yet to be a Medical Smartwatch that can manage chronic diseases like diabetes, as well as to measure blood pressure and heart rate. We will track our progress through an outcome-based evaluation technique. Our goal is to promote a healthier lifestyle for our users. Omron, a blood pressure monitor company, says “it’s been over a year since the new blood pressure guidelines were released and 103 million Americans were recategorized with high blood pressure. That’s nearly 1 in 2 of us. How are YOU doing?” (2018). Our smartwatch would allow for daily blood pressure measurements, completely overcoming the obstacle of finding a place to get your blood pressure taken. This feature has the potential to completely change the lives of users; According to Verdict, “free-living gait analysis at home is particularly useful as it allows objective observation of an individual’s day-to-day activity. It also has the benefit of providing continuous data over a prolonged time that may be more sensitive than one-off assessments” (2018). Very similar can be said of the daily heart rate monitor we have incorporated into our watch. Using an outcome-based evaluation technique, after producing our Medical Smartwatch, we will determine if our goal of promoting a healthy lifestyle has been attained.

Task Schedule

Month 1

Obtain the pieces of the technology behind Medical Smartwatch (i.e. Display/Touchscreen, sensors, battery, circuit boards (PCB), wristband, switches, charger, carrying case, packaging).

Month 2-20

Create a prototype of Medical Smartwatch and software basis.

Month 21

Introduce Medical Smartwatch to the public.

Month 22-32

Review results of Medical Smartwatch (both good and bad). Based off results, determine if our goal of promoting a healthier lifestyle was hit and to what extent. More specifically, what features of our watch helped users best when it came to making healthier choices. Also, on the other hand, what features may need to be added to improve our Medical Watch. For example, a swim proof feature so that users would be able to keep the watch on while under water.

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