SpiceJet’s flight SG-141 took off from New Delhi after an hour’s delay at 9.30pm on 18 January. As the plane lifted, so did Anand Madanagopal’s spirit—he was returning home after winning the Google Grand Jury Prize at the StartupIndia Launchpad. An hour into the flight, the impressions of the event were crowding in his mind when he heard a loud thud. A young man had collapsed at the lavatory door. The air hostess rushed and raised his legs.

After a few minutes of nervous flutter in the aircraft, Madanagopal hesitantly took out his mobile intelligent remote cardiac monitor, MIRCaM, and strapped it on to the man. The heart rate was low at 40, but the graph plotting on the tablet screen showed no adverse cardiac event. “There was a physician on board peering over my shoulder; the pilot came out of the cockpit and offered to make an emergency landing at the nearest town. They were all looking up to me to make a decision; I was anxious, but I relied on my device. The heart rate had begun climbing up, the expert system in the device showed no infarct. I took a chance and we came to Bengaluru," he says.

On landing, once again everyone waited for him to decide the next steps. He brought the 22-year-old to MS Ramaiah Hospital where he showed the ECG recording to the doctor. By then, the guy was walking and ready to go home.

It was an impromptu test for the diagnostic solution that Madanagopal had been developing at his four-year-old Cardiac Design Labs (CDL). The circumstances, location and the outcome on that January night proved all he had been labouring to prove in any case: Everything that ECG-based devices do for cardiac disease diagnosis and monitoring can be done in a mobile environment and, more importantly, in real time.

To a large extent, ECG has seen commodification. Like noting body weight and height, recording ECG for a walk-in patient has become routine. Many cardiac hospitals run free ECG tests in their out-patient departments.

View Full Image Everything that ECG-based devices do for cardiac disease diagnosis and monitoring can be done in a mobile environment and, more importantly, in real time. Hemant Mishra/Mint

The irony is, routine examination is a resting ECG test which can detect only acute cases. So, if you have palpitation or unnatural sweating one day but you choose to see the doctor the next day, or even a few hours later, there are high chances that the ECG, a mere 10-12 seconds of electrical function analysis, will detect nothing. “When you lie down, the heart rate itself falls, the load on it is nil; it doesn’t even have gravity straining it," says Madanagopal.

“That’s correct, which is why real-time monitoring is any doctor’s most-desired tool," says Dr Ashok Seth, chairman of Fortis Escorts Heart Institute in New Delhi. “Today, we have a few such devices, but either they are single lead (that is, electrode) or they are not fully automatic; one needs to manually download the recordings."

Similar challenges in rhythm abnormalities began to be addressed when the Holter monitor came into clinical use in the early 1960s. Typically, a patient wears the device for 24 hours after which it is plugged into a PC for a post-facto analysis. Less than 20% of hospitals have front-line devices to detect arrhythmia or coronary heart disease.

India would not be able to afford four devices, Madanagopal thought, and built one to do the work of all—from clinics to ambulance, intensive care units to post-operative care—at home.

“Doctors don’t like this. They have told me you are hitting under the belt. If you want, please do four devices, but don’t make it so comprehensive. I am collecting all feedback, I’m at the cusp of learning," he says.

The instrumentation itch

The bug of learning was always there, which would make him wonder “why only the Germans could build BMW". Back in the tech slowdown of the early 2000s, when outsourcing projects were drying up at Tata Elxsi, Madanagopal was sent for an on-site project at Texas Instruments. When testing projects were handed out to him, he remembers fighting with the sales manager over the quality of work. He said he could do a lot more. “I was grumpy in that TI meeting. I had this horrible patriotic feeling when anyone implied that we could only do simple jobs," he says. “I said if he gave me a team, I could build the whole product. Finally, he gave us the full portion and we built the DVD writer full stack. I don’t have a pedigree, I am a simple MCA; I did my masters from BITS-Pilani while working at Tata Elxsi, but I know instrumentation."

Everyone in Tata Elxsi understood Madanagopal had to strike out on his own. So, his managers would invite him to meet “interesting" people visiting the company. One day in 2010, he met P.V. Gopal, co-founder of Alpha X-Rays, which was acquired by Philips in 2008. “Gopal told me, ‘unless you get out of (Tata Elxsi), you can’t do anything’. I quit on the fifth day from that meeting," he says.

The next six months were spent researching. Healthcare was his hobby reading from high school when he would devour Know Your Body volumes from Reader’s Digest. “I decided it would be a non-invasive, diagnostic device which would solve a problem," says Madanagopal.

His neighbour, T.R. Raghunandan, who knew Dr K. Mohandas, former director of Sree Chitra Tirunal Institute for Medical Sciences and Technology, sent him to Thiruvananthapuram.

“Mohandas told me, ‘This country doesn’t work by merit; it works by people who know people. Since Raghu has sent you, I’ll spend time with you’," says Madanagopal.

An anesthetist and administrator, Mohandas was part of the team that built India’s first heart valve, Chitra Valve, a massively collaborative project under the Union health ministry. Through its engineering head, Aswath Ramani, Madanagopal landed at the desk of Dr M.S. Valiathan, the architect of the valve, who later became the first vice-chancellor of Manipal University.

“I am a cardiac surgeon, not a cardiologist, but I know ECG devices like Holter reach only 10% of the patients. Even here at Kasturba (Medical College), when a patient comes with palpitation, we have to put him on a Holter, but cannot do that straightaway; we ask him to take an appointment, which often is after two weeks. So, I was impressed by the idea Anand was presenting, especially that it would be so rugged and simple that a farmer could transmit data from the field. I gave him lot of encouragement, as I give to all medical device developers," says Dr Valiathan.

Ramani, the engineering brain behind several medical technologies developed at Tirunal and who came to TTK Group in 1992 when the former transferred the technology, became his mentor. An electrochemical engineer from Indian Institute of Technology Madras, Ramani held his hand but more crucially, convinced his former colleague from Tirunal Institute, cardiologist Dr K.G. Balakrishnan, to guide Madanagopal.

Balakrishnan took his time, nearly 10 sittings over biscuits and tea at his residence. “Anand came up with many things which were not feasible. Finally, he took this up and thought of telemetry over 2G," he says. The main purpose of ambulatory ECG is to see the irregularities of heartbeats, but the disturbances due to movement are so high in Holter that the interpretation of another important complication like ischemia is not easy. Ischemia or coronary heart disease occurs when there’s reduced blood supply to the heart due to the narrowing of arteries.

“If you don’t get a steady baseline, how will you interpret ischemia?" asks Balakrishnan, now a senior consultant at Fortis Hospital in Bengaluru. “What CDL has built is a unique system in the world where we can detect irregularities of the beats as well as ischemia."

While Madanagopal was figuring his way, one day in 2011, he walked up to Sashi Kumar who lives across the street from him. Kumar often eyed Madanagopal’s Land Rover, a vintage 1958 olive green SUV. It was Kumar’s last day at Microsoft; he had a six-week break before he joined SAP. “Anand said he was working on an idea and needed help to flesh out a business plan. I was more interested in his Land Rover than his business idea. But we hit it off," says Kumar, who is now the managing director and CEO of Happiest Minds. The inclusive nature of the business attracted him.

Hammering it out

Outside, the mercury touches 37 degrees Celsius, but the asbestos roof of the tricked-out garage amplifies the heat inside. Mosin Badkar has MIRCaM strapped on to him for a demonstration. The R&D chief is using it on himself for the first time. The heart rate is 96. Isn’t it on the higher range? He brushes off the observation, linking it to his higher-than-average weight. A few minutes into the reading, the electricity goes; and a while later, the UPS starts beeping. The solo pedestal fan has to be switched off; Badkar’s heart rate shoots up to 123. Before anybody can react, he says, “Without air-conditioning, our productivity goes down in this place, please write it down."

“We are a start-up, we cannot afford an AC," jibes Madanagopal.

Everything about the place embodies the hands-on approach of the founder, reminding one of the Japanese concept of mottainai (let nothing go waste). The 900-odd sq. ft of office space is a garage that was converted into an office by hand, literally. The ground floor looks like a mechanic’s shop floor and the first floor, made of waste-packing wood bought at ₹ 7 a kilo, resembles more a loft in a barn than a workspace for a dozen engineers. A welded staircase connects the two floors. The side walls have embedded pigeon-hole shelves, the kind used by a post office to sort mail but which Madanagopal picked up from scrap to store tools.

Next to the modest conference table is a green hand-moulding machine. Laser cutting, bending of sheet metal and assembly of the bodyworn are all done here. The idea was to avoid injection-moulding because the initial years require a few trial moulds, which itself can cost upwards of ₹ 50 lakh, says Praveen Murthy, who heads hardware and production.

The garage is a reflection of the intricate instrumentation that runs through CDL—from the device to the app. At the core of MIRCaM is a bodyworn, weighing 165 grams, with 10 electrodes (which constitute 12 leads in a full-scale ECG) tethered to 1 mm coaxial cables. The display or the patient-side device is a Samsung tablet where all the intelligence rests; it’s a phone if used in ambulatory care. The ECG is recorded in the bodyworn, transmitted to the tablet or phone via Bluetooth and then reported in the cloud and to a doctor’s device over 2G. Other ECG machines push PDFs or images to the hand-held device; MIRCaM sends raw binary data along with metadata to the device, in effect suggesting to a doctor how to treat the patient even as the app plots the ECG on the phone. This ‘instrumentation in the app’ keeps the size of the file low, just about 100 kb, which enables transmission over 2G.

“Because the entire intelligence is on the back-end device—most companies try to load the front end—only cardiac events are pushed into the cloud or the doctor’s phone. In case of an event, the expert system can send alerts, which can be customized. Say, you are jogging around a park and you experience pain, the doctor can analyse in real time what is happening—it could be a rhythm problem or a secondary block," he says.

It’s the copious programming that does the trick. Many ECG systems use an off-the-shelf algorithm; companies in Western Europe and Ireland rule the market. For instance, BPL ECGs use a Glasgow University algorithm.

“A few vendors said we will give you the algorithm and you can do something more than the call centres. An Irish company we identified wanted $200 royalty per product, so we decided to do everything ourselves, and from scratch," says Badkar.

He recently relocated to Bengaluru after working for STMicroelectronics and ARM R&D centres in Bristol, UK. Along with his former Tata Elxsi colleague Murthy, Badkar had been working remotely on MIRCaM till it reached a stage where they could join full time.

How they put together their algorithm is notable. For two years, twice a week, they took cardiology lessons from Dr Balakrishnan, converting the textbook knowledge of cardiac diagnosis into codes.

“Basically, what I have taught them is the electrical happenings of the heart, not the real pump action. For every abnormality, there is an explanation; they noted meticulously and converted everything into an algorithm. We cross-checked how our intelligence worked on MIT (Massachusetts Institute of Technology) data and I can say MIRCaM’s accuracy beats conventional methods," says Dr Balakrishnan. (MIT-BIH arrhythmia database is the international benchmark for testing the performance of such algorithms.)

A clinical study at Kasturba Medical College in Manipal between October and December 2014 on 73 patients showed a complete match between MIRCaM’s and doctors’ diagnoses.

Unlike other systems, which use every new ECG against a data set of disease ECG to see how close the match is, MIRCaM doesn’t have a disease data set. It pulls out recording segments and analyses them just as a doctor would do. In many countries, large device makers run call centres where technicians mark out disease segments from the recording which, of course, add to the cost of the test.

Getting to this stage wasn’t a cakewalk though. In mid-2014, they deployed MIRCaM at Kasturba Medical College under Dr Ranjan Shetty, who gave them a taste of complexity on the first day. They had barely driven 20km when Shetty called to say that the device wasn’t behaving well. On return, they found the ECG was plotting, but a weird V-shaped graph and the screen showed no heart rate. It was a slightly rare case, of atrial ectopic beats, and Shetty, the canny doctor that he is, challenged them saying the device should detect all kinds of patients.

“We went back to basics. Sacked our signal processing expert; Mosin and I rolled up our sleeves and did the entire signal processing ourselves," says Madanagopal.

“I have been critical from the beginning because at the back of my mind is the rural setting in which this ought to work. Other devices detect offline, this one does real time, which itself is a big advance. But ECG as a whole has a limitation—it can’t pick up 3-4% of heart attacks. For the rest, I suggested to them to over diagnose, not miss even a borderline case," says Dr Shetty.

Before CDL came to him, he was actively working to develop a hub-and-spoke model in Udupi between 59 primary health centres and the district hospital where at least with some training and an intelligent algorithm, the local caregiver could tell whether it was myocardial infarction or not.

As the team improved the algorithms, it also built an active patient management workflow. With a single app, a hospital can organize which set of smaller feeding centres will go into the intermediate centre, direct them to different doctors, and so on. Multiple configurations are possible, but each user will see only what it is supposed to see. In all this, they may have made it as simple as using WhatsApp, which is actually their competitor, to an extent.

“In many hospitals, duty doctors send ECG on WhatsApp. They keep sending multiple pictures, but they are using this app," says Madanagopal.

In the past 18 months, CDL has won a few awards; one of them being the ‘Most Innovative Product’ award from India Electronics Semiconductor Association, where General Electric (GE) as a category sponsor gave away the award. Since then, the industrial conglomerate has engaged with CDL, even considering investing in the start-up at one point, but when GE Capital was hived off in 2015, the engagement slipped into a limbo. (When contacted for this story, GE refused to comment.)

But most ECG device makers, even users, will be watching CDL as it begins to enter the market this year.

Disrupting the system

Could it make an impact in the underserved market or disrupt the cartelization itself where healthcare providers want to control the full value chain?

The outlook for cardiac care has been growing grimmer. Heart diseases account for nearly 30% of all deaths in India; 90% of the 64 million patients go to small hospitals where there is no cardiologist, and there are just about 5 heart doctors per million people. Therefore, on paper, India looks like fertile ground for all that is remote care delivery; in reality, telemedicine has remained confined to pilots, which each big hospital can claim to have done (and which find mention in their conference presentations).

“Telemedicine has failed mainly because what remote locations need is therapy at low cost on site, which we cannot provide. If we could do 70% of what we do on site here, it would create the tier system whereby only the sickest need to go away from primary and secondary centres," says Dr Seth.

In the early 2000s when the Indian Space Research Organisation (Isro) offered free satellite communication services, Narayana Hrudayalaya was the first to use it for tele-consultation. Most other big hospitals followed, without thinking through their business model around it. A few years later, when Isro went soft, hospitals could not scale it because they had not invested in technology, says Vishal Bali, co-founder and chairman of Medwell Ventures and former group CEO of Fortis Healthcare.

“Look at where teleradiology has gone—it has connected to the world. That’s because it is just movement and archiving of images. But cardiology needed live data transfer for which medical technology was not ready. It also couldn’t happen over 2G or the kind of network we had. So, for many, telecardiology became a follow-up activity," says Bali.

View Full Image CDL intends to sell the device at about 45,000 and take a fee every time it’s used on a patient. Photo: Hemant Mishra/Mint

For now, CDL is installing MIRCaM at a few cardiac centres in cities, but it knows real customers are in smaller towns—general practitioners (GPs), clinics, and 20-30 bed hospitals (which do C-sections but not use a bedside monitor). It intends to sell the device at about ₹ 45,000 and take a fee every time it’s used on a patient.

“Through software-as-a-service model, it could help GPs in the hinterland read ECGs, maybe even ayurvedic doctors who are probably giving the wrong diagnosis," says Bali.

Pay per use has been tested for a while. Most equipment makers, including GE and Philips, have tried this, but none has made a success of it.

The economics of direct pay per use with GPs doesn’t work out, says Priyank Agarwal, vice-president and head of strategy and business development at Philips India. “If CDL’s device costs ₹ 40-50,000 and in tier-I, II towns, ECG costs ₹ 150-200, there is hardly any money that can be shared in the fee and still make it worthwhile. Additionally, most GPs are not trained to read an ECG," says Agarwal.

To address that, doctors are advising Madanagopal to build the “complete hub" where expert system-referred patients coming from remote areas will be seen by a panel of cardiologists and then forwarded to hospitals.

How far will the patients be spared repeat examinations when every centre today wants to prescribe its own tests?

“There will be some repeat of some tests, but not all. Remember, analysis of these readings will come at a cost," argues Dr Seth.

Madanagopal believes he’s already solving one problem—saving unnecessary travel of remote patients for the first line of diagnosis, even therapy to some extent. “We will attack the second problem (of repeat testing) gradually," he says.

Agarwal believes a sizeable opportunity lies in the deployment by cardiologists and hospitals to increase patient flow. “Say, a cardiologist deploys 10 machines, which increases his outlay by ₹ 2.5-4 lakh, but through this his referral, patient flow increases. And if he is able to increase utilization of his cathlab, then the investment pays off in a handsome way," says Agarwal.

Several cardiologists and hospitals are already deploying this model, but there is potential to increase this further.

That still doesn’t serve the purpose with which Sashi Kumar and Madanagopal made the business plan five years ago—to make cardiac care inclusive.

Tough-minded, yet wryly maverick, Madanagopal, 43, takes Dr Valiathan’s words seriously—a high-quality, inexpensive device is no guarantee that it will be a market success. He has been fending off a serious offer from one of the largest hospital chains in the country, which wants to white label his product on its own pricing terms.

“Earlier, I thought I would be happy to touch a few million lives. But during the Google event, Rajan Anandan spent a lot of time understanding our product and suggested our target should not be a few tens of millions but hundreds of millions. Now, I am convinced about it," he says.

Some of the responses to his technology have added to his resolve. At a recent conference, Azad Moopen, physician-founder of Aster DM, the healthcare conglomerate in West Asia, “walked up to him and said he would like to work with him because he thinks personalized home care is the future".

The Australian government in Victoria invited him in March where Dr Ian Meredith, head of MonashHeart at Monash University, offered to run a clinical test in the ambulances where traditionally single-lead ECGs are used in ambulatory mode and hence give limited cardiac diagnosis. In Hyderabad, GVK, which runs India’s largest emergency 108 ambulance services, is interested too.

Single or dual business models will not solve his or the patients’ problem, so Madanagopal is treading cautiously. Investors are “queuing up with blank cheques" but he says he is not “ready for VC money yet".

As a first-time angel investor, when Kumar wrote the first cheque of ₹ 30 lakh for CDL, he wrapped it in some advice—Do not raise a lot of money in early years. “It’s a simple principle—money coming in has to go back. If investors come, a lot of expectation has to be managed; if it’s debt, then only money has to go back. To keep his ethos and purpose intact, it’s important that he does not dilute himself hard," says Kumar.

Madanagopal is closing the seed round of $500,000 before he secures Europe’s CE certification (which comes at a fee of ₹ 30 lakh). That would allow bigger hospitals such as Manipal and Medanta to test-use the product.

As vice-president of business development and sales, Ravie B. Kaushik has identified 18 customer segments, including long-haul flights, which will soon have Wi-Fi and can provide on-board consultation in an emergency. “By the year-end, we want to touch patients directly—give them a Velcro belt and make them wear the device to work. I believe somewhere the urban and rural requirement will meet," he says.

Bali has a good analogy for that. Like super-speciality branches of big hospitals that went from big cities to smaller towns, he says these cost-effective and often smart technologies will follow the reverse route and come from smaller towns to big cities.

For Seth, it’s a matter of time before personalized, cheaper and continuous care becomes the norm.

Madanagopal is in it for the long term, and for business. “I will not do anything unethical, but I am not out to stop the ‘cut’ practice in the industry," he says.

Before starting out, he saw India as an elephant in a pit. “I thought we literally have to gouge out the pit to get out of it and be seen." He’s preparing to do that in an industry that is ripe for disruption—too many people for too long have been doing the same thing.

Seema Singh is a Bengaluru-based journalist. Her book Mythbreaker: Kiran Mazumdar-Shaw and the Story of Indian Biotech was published by HarperCollins last month.

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