Electronics engineer duo Rahul Rastogi and Neha Rastogi have co-founded the world’s first touch-based digital portable ECG machine, which can be used by individuals at home for screening heart-related ailments.

According to the developers of this device, the device has CDSCO approval in India and is currently being used by over 20,000 doctors.

Their company Agatsa, recently won the prestigious Aegis Graham Bell Award, for this device.

Having established itself firmly in India, the company is now in touch with different agencies for getting a clearance from the United States Food and Drug Administration (USFDA) for marketing the product abroad.

Moneycontrol spoke to Neha and Rahul on their journey to develop the portable ECG device and the road ahead. Edited excerpts:

How did this idea of making a portable ECG device come up?

NEHA: Rahul is the founder and creator of the device. Rahul’s father was detected with a cardiac problem and he was advised ECG every time there was chest pain. Doing an ECG every time was a long and cumbersome process. That is when the idea of a portable ECG machine, which can be used by individuals at home, came to our minds. We started doing our research on the principles of ECG, and how it could be miniaturised and used as a small device by individuals.

What were the suggestions that you received from cardiologists while you were in the process of developing this device?

NEHA: The doctors suggested that a 12-lead ECG will be beneficial not just to people who would use it but also for the doctors because doctors don’t have the huge ECG set up at their clinics and small hospitals.

That’s when we started working on developing a 12-lead ECG device, which was the first in the world. No other small product existed till then which could take 12-lead medical-grade ECG in this small form.

The result generated from the device is equivalent in medical accuracy to hospital-grade ECG machines, while the machine is 1/10th in size and cost.

In 2016, we launched the beta version, and a year later, the commercial version on Amazon.

Over 60 percent of the buyers of our product are doctors.

Tell us about the machine’s validations and regulatory approvals. Which hospitals were you in touch with while developing this device?

RAHUL: We started conducting proper clinical validations in 2017 by tying up with Jayadeva Hospital in Bengaluru. We approached the ethics committee, the trials took place and reports came out to be 99 percent accurate.

We conducted another validation trial with Narayana Hrudayalaya in Bengaluru, which went on for three months. A team of about 15 doctors was set up to complete the trials.

Validation trials were conducted at the All-India Institute of Medical Sciences (AIIMS), Delhi, too. These reports were published online and the data was peer-reviewed.

The device has also been tested for bio-compatibility. After getting the results, we filed for ISO certifications. For the third year running, we have been certified as fully internationally compliant for ISO. We have been approved by the CDSCO (Central Drugs Standard Control Organisation).

Tell us about your expansion plans? Are you eyeing US FDA clearances?

RAHUL: We are working with different agencies for US FDA clearances, and also CE (Conformitè Europëenne) validations because there is a lot of demand for this kind of machine in the international markets. We plan to move to the US market by next year.

Please tell us about the user-friendliness of this device.

RAHUL: When a person buys this device, he/she gets five to seven onboarding calls from us. We explain how the device is used. This device is so tiny that even while sitting in the car you can conduct an ECG. The report comes out in PDF form.

Our ECG reports have been underwritten in certain cases by insurance companies. A large number of corporate tests have also been done using our device. Those ECG reports are under-written by doctors because they are almost 100 percent accurate.

How many doctors are currently using this portable device? What is the pricing model?

NEHA: Almost 20,000 doctors are using our device. We are seeing the machine being used in both rural and urban areas. We like to keep the cost of the hardware at a minimum, and have adopted the pay-per-use model.