Loss of friend prompts Dehradun technician to develop portable ECG device

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Six years ago, Rajat Jain lost a classmate to a heart attack. He was only 21 years old. The loss rocked Jain who was then studying engineering at a college in Dehradun and led to the development of ‘Spandan’, a portable smartphone-powered ECG machine.

“I have seen people live with heart problems. When they have a heart attack, they often confuse it with stomach pain. Most are unaware of early symptoms in India,” says Jain, who founded Dehradun-based Sunfox Technologies.

The idea behind a portable ECG machine was to help people living in remote areas get access to proper diagnoses of early symptoms. An electrocardiogram (ECG) is a reliable method for collecting electrical signals generated by the heart, studying the heart’s rhythm, and diagnosing problems. But ECG machines are still expensive and can cost more than Rs 1 lakh. They must also be operated by trained professionals.

According to the World Health Organization, heart disease is among the leading causes of death worldwide. (Image credit: Sunfox Technologies)

“All of this limits ECG machines to hospitals and tertiary care centers,” says Jain. Additionally, the government policy that puts ECG machines on a list of wanted items, not essential items, adds to the problem. In addition to this, most districts have no more than one catheterization laboratory. Worrying for a country that now accounts for 13.86% of total deaths from heart disease worldwide, 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 obtain regulatory approval to bring the product to market. From its inception, Jain wanted to make Spandan a replica of a reference ECG machine, but in a portable format.

Jain describes Spandan as a “plug and play” device that is as easy to use as a pair of headphones. Weighing just 12 grams, the device is smaller than a car key and can be kept in a matchbox. The device uses no battery, has no moving parts and is completely buttonless. “It’s the lightest version we could have created,” says Jain when designing the portable ECG machine.

The final prototype of the Spandan portable ECG machine. (Image credit: Sunfox Technologies)

Spandan works with a smartphone, and that’s what makes it unique. Inside, the electronic components of the device retrieve the data from the trunk and then transmit it to the smartphone. The wearable ECG machine connects with two cables – one goes to your phone and the other allows you to stick the electrodes on your chest. The whole process is safe and painless, claims Jain.

To use the portable ECG device, users need to download a mobile application from the Google Play store. The same app tracks and generates PDFs of health reports that can be shared with a doctor via email or WhatsApp. Jain says the mobile app has the ability to notify the user of irregular heartbeats (arrhythmias) as well as extract the HRV signal, which is defined as the time interval between consecutive heartbeats measured in milliseconds. There is also a live monitoring feature which monitors users on several parameters such as oxygen levels and respiratory levels.

Jain’s Spandan app does not depend on the internet or mobile signals to deliver the results. This means that users can perform a mobile ECG in high altitude regions where the networks are a bit uneven.

The Spandan device went through several stages of prototype and ideation. “The first variation we designed in-house was limited to rhythm monitoring only, but at a later stage we found that there are many devices that can monitor your rhythm,” says Jain. “The main challenge comes when you have to watch for a blockage or an ischemic change that causes a sudden heart attack,” says Jain, who was helped by Dr Yogendra Singh, Associate Director of Cardiology at Max Super Specialty Hospital, Dehradun.

The Spandan device relies entirely on the smartphone for computing purposes. (Image credit: Sunfox Technologies)

Unlike the Apple Watch which replicates a single-lead ECG, Spandan records a 12-lead ECG, the gold standard for measuring the electrical pattern of the heart. A 12-lead ECG measures the heart’s electrical activity in multiple directions and planes and is very sensitive and Jain says that’s why Spandan is a medical device that can be used for diagnostic information.

The results take 10 seconds to get and, according to Jain, they are 99.7% accurate based on trials of over 3,000 people between 2017 and 2021. “The amount of data and the quality of the data that you get from a standard ECG machine inside the ICU will be exactly the same as the data that Spandan gets,” says Jain, adding that AI and the use of machine learning algorithms have helped improve accuracy.

Designing and manufacturing Spandan in Dehradun has not been easy due to lack of R&D ecosystem and skilled resources required, admits Jain. “There are a lot of dependencies in the hardware. This is not the case in the case of software development which can be made from a single piece,” says Jain, adding that the challenge is to understand that regulatory requirements make it more difficult for medical equipment. .

Spandan is now being sold for less than Rs 7,000 via Amazon, 1MG and other online retailers. The device does not require a subscription or the intervention of a doctor. This year, Jain aims to move 100,000 Spandan units, up from 50,000 last year. New versions are also in the pipeline which will create a clear distinction between home care and hospital use.

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