Six years ago, Rajat Jain lost a classmate to a heart attack. He was only 21 years old. The loss shook Jain, who was then studying engineering at a college in Dehradun and led to the development of ‘Spandan’, a portable ECG device controlled by a smartphone.
“I saw people living with heart problems. When they have a heart attack, they often mistake it for stomach gastric pain. Most of them are not aware of the early signs in India,” explains Jain, who founded Dehradun-based Sunfox Technologies.
The purpose of the portable ECG device was to help people living in remote areas access a proper diagnosis of early symptoms. An electrocardiogram (ECG) is a reliable method for collecting the electrical signals generated by the heart and for studying the heart’s rhythm and diagnosing problems. But ECG machines are still expensive and can cost over Rs 1 lakh. They must also be operated by trained professionals.
“All of this limits ECG machines to hospitals and tertiary care centers,” says Jain. The problem is further compounded by government policy that places EKG machines on the list of required items rather than essential items. Additionally, most counties do not have more than one cat lab. This is alarming for the country, which now accounts for 13.86 percent of total heart disease deaths, according to a recent study.
Work on Spandan began in 2016, and it took Jain and his team four years to complete development, conduct clinical trials and gain regulatory approval to bring the product to market. From its inception, Jain wanted to make Spandan a replica of the gold standard EKG machine, but in a portable form.
Jain describes the Spandan as a “plug and play” device that is as easy to use as headphones. The device weighs just 12 grams, is smaller than a car key, and can be stored in a matchbox. The device uses no battery, has no moving parts, and is completely buttonless. “This is the slimmest version we could make,” Jain says of the design of the portable ECG device.
Spandan works with a smartphone, and that’s what makes it unique. Inside, the device’s electronic components take data from the chest and then transmit it to the smartphone. The portable EKG device connects with two cables – one goes to your phone and the other allows you to stick the electrodes to your chest. The entire process is safe and painless, according to Jain.
To use the portable ECG device, users must download the mobile app from the Google Play Store. The same app tracks and generates PDF health reports that can be shared with a doctor via email or WhatsApp. Jain says the mobile app has the ability to alert users to irregular heart rhythms (arrhythmias) and also extract the HRV signal, which is defined as the time interval between consecutive heartbeats measured in milliseconds. There is also a live monitoring feature that monitors the user on various parameters such as oxygen level and respiration rate.
Jain’s Spandan app is not dependent on the internet or mobile signals to provide results. This means users can perform mobile ECGs in high-altitude areas where networks are a bit patchy.
The Spandan device went through several prototype stages and thoughts. “The first option we designed internally was limited to just monitoring the rhythm, but at a later stage we realized that there are so many devices that can actually monitor your rhythm,” explains Jain. “The main problem comes when you have to monitor a blockage or ischemic change that causes a sudden heart attack,” says Jain, who was assisted by Dr. Yogendra Singh, associate director of cardiology at Max Super Specialty Hospital in Dehradun.
Unlike the Apple Watch, which replicates a single-lead ECG, the Spandan records a 12-lead ECG, which is the gold standard for measuring the heart’s electrical pattern. The 12-lead EKG measures the heart’s electrical activity in multiple directions and planes and is highly sensitive, which Jain says is why the Spandan is a medical device that can be used for diagnostic information.
It takes 10 seconds to get the results and, according to Jain, has an accuracy of 99.7 percent based on tests done on more than 3,000 people between 2017 and 2021. “The amount of data and the quality of data you get from a standard ECG machine inside the ICU will be exactly the same obtained by Spandan,” says Jain, adding that AI and the use of machine learning algorithms have helped improve accuracy.
Designing and manufacturing Spandan in Dehradun was not easy due to the lack of an R&D ecosystem and skilled resources required, admits Jain. “There are a lot of dependencies in hardware. That’s not the case with software development that can be done from one room,” says Jain, adding that the challenge is understanding the regulatory requirements that make medical hardware difficult.
The Spandan is now selling for less than Rs 7,000 through Amazon, 1MG, and other e-tailers. The device does not require a subscription or the intervention of a doctor. This year, Jain aims to move 100,000 units of Spandan, up from 50,000 last year. New versions are also in the works to create a clear distinction between home health care and hospital use.
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