The BHAD (Big Hairy Audacious) plan… to change the world.

Awarded the

“Rodinstar” Post 

of the week!!

The stent/balloon business was dying. I had to do something different.

Along with the need to do something more different was a deeper, more existential question. Was I here to sell assorted things to make a living? Or could I do something Big, Hairy, Audacious in terms of contribution to humanity, as well as $$$ profit?

I didn’t have to look far for opportunities. The diagnostics and treatment of CAD was a trillion dollar beast. CAD killed off more people than all the cancers combined. It offered the canvas to do something BHAD. There was big money, as well as good karma to be made.

Feeding the beast was anentire brigade of giant companies, making huge profits. Doctors and hospitals were overflowing with patients, whose families spent their entire fortunes on diagnostics and treatment. With the growing epidemic of lifestyle diseases, CAD would be a profitable ride for everyone for centuries ahead.

I spent hours at Cardiac Hospitals and Cath-labs, overflowing with desperate patients and short-handed (and sometimes rapacious) doctors. I realized that a significant number of patients were young, and whose first symptom was a Pain or a mild heart attack. I discovered in the course of my research that CAD was nicknamed the Silent Killer. Dr.James Fixx, long distance runner and author of several books on the subjects, famously and tragically collapsed and died after his morning run in 1984 aged 52. The autopsy revealed he had CAD, with 3 blockages of 95, 85, and 75% respectively. Death was the only symptom.

I started appreciating the difficulties that GP’s, the frontline soldiers against the battle against CAD, faced. The main weapon in their arsenal against heart disease is the trusted, if stodgy ECG, dating back to 1872. (Its inventor, Willem Einthoven was awarded the Nobel Prize in 1924 for this). While the ECG does have several uses, its predictive accuracy in the case of CAD is poor.

Doing an ECG to predict CAD was like tossing a coin. It would give high False Positives, which wasted money in the form of subsequent testing as well as False Negatives, which could mean lives lost prematurely.

There is a whole arsenal of tests to help detect suspected CAD. Coronary Angiographyis theabsolute Gold Standard of diagnostic tests for CAD. It involves a puncture in the Femoral Artery, followed by injection of a Radio-opaque dye into the vasculature. X-Ray photographs are then taken, and these X-Rays capture and quantify the nature, extent and location of the potentially dangerous occlusion(s). Angiography is painful in several ways; apart from taking on a few years worth of radiation in 3 minutes of photography, it cane be occasionally fatal. To most people, it was a full-fledged surgery, with the entire attendant trauma – and cost.

What, I asked myself, if we created an ECG so powerful that it had great predictive accuracy, and could act as a highly reliable “gatekeeper”. Such a technology would need to be simple to administer, was cheap, and did a good job of “screening” CAD prospects. Given its high diagnostic accuracy, it would save the system enormous costs in terms of fewer unnecessary tests, and sending only those it deemed necessary into the expensive portals of specialist physicians, advanced diagnostic tests and cath-labs.

I started feverishly researching.

I stumbled upon a clinical article in the Journal of Biomedical Instrumentation & Technology, written by a certain John C Fisher. It spoke about a potentially revolutionary diagnostic technology, based off Spectral Analytics of ECG Signals. ECG Signals are time domain signals and are inherently low bandwidth, or contain limited information. However, when converted into a set of Frequencies, by application of Fourier and Laplace transforms, the signal becomes very rich, permitting far more sophisticated and nuanced interpretation.

At the end of the Scientific Article was a mind-boggling scientific anecdote.

“From the science of oceanography comes a superb example of the ability of spectral analysis to detect minute changes in time waves. The following is from the preface to Blackman and Tukey, a 1958 Article, The measurement of Power Spectra. I quote “…we were able to discover in the general wave record a very weak low-frequency peak, which would surely have escaped our attention without spectral analysis. This peak, it turns out, is almost certainly due to a swell from the Indian Ocean, 10,000 miles distant. Physical dimensions are: 1 mm high, a kilometer long…”

The Fischer article cited the example of one Auragenics Inc., which had a proprietary “brain” based on a the power of spectral analysis. Basically the product had a brain size of 20,000 real patients. For every patient it had the Angiography, whichprecisely quantified the gold-standard diagnosis, as well as the 12-Lead ECG signals of all these patients. The product broke down the ECG signals into spectral components and correlated these with the gold-standard/CAD diagnosis. Based on this, it would give a verdict; initial trials in Brazil, Italy and New York were positive. The technology was out of the University of Beijing in the 1980’s. It was beginning to see commercial traction.

I felt like the man who saw the future. This was a fabulous product. In the hands of the GP’s I could put a simple machine that, without stressing or invading the body, produce a result very close to Gold Standard Angiography. It would save thousands, millions of lives. People would only spend on expensive techniques if the initial screens were doubtful. The calculations of the billions of dollars in potential wasted cost of testing spun in my mind. The applications were even more relevant in a poor, overpopulated country like India.

A big application could be Health Insurance. Insurers would be intelligent enough to detect severity of disease and price more appropriately. Healthy people would get charged less than unhealthy people as determined by this super brain of a doctor. Today, healthy people get charged the same premium as unhealthy people since simple, non-invasive tools to granulate severity of CAD do not exist.

I quickly made contact with Auragenics a medical startup in New York. I began bouncing off the concept with doctors. Many were skeptical, but almost everyone agreed that it was a noble idea.

I decided to take the plunge. I mustered every last scrap of cash I had for this big do or die attempt. I spent money in impressing Auragenics. I decided to launch the product at the largest gathering of the Interventional Cardiology exhibition in Mumbai. I would get the Auragenics reps down, and offer tests to visitors (including several doctors from interiors of India), as part of beta testing and consumer researching the product. Expensive brochures were printed. I paid a PR agency (which did a very crappy job).

I was deliriously absorbed in the intensity of the mission. The launch was a success; the idea was uniformly praised as one that was revolutionary.

I installed the machine in Dr.Pinto’s clinic. I would come there every evening at 5 PM, to take tests of the patients and produce a diagnosis. Dr. Pinto would then look at the diagnosis we would contrast his opinion with the machine’s opinion. The initial results were promising, but merited further scientific study, which we decided to conduct as a workshop by Dr. Pinto.

We would measure the patient before the angiography and then compare and contrast the findings of the machine with the angiogram. It was a true shootout.

Tests of the machine were done for a 12-hour session. The technology started showed its deficiencies. In some cases, it was positive, but a worrying percentage of the time, it gave false negatives. The number I then started looking for was false negatives for medium to advanced coronary disease. They started creeping up over the research. Adding to my disquiet was the fact that the machine needed significant interpretative power from the Auragenics rep. Both bad signs.

I stressed tested the machine in Dr. Pinto’s clinic but the data was definitely not hot. The machine was a failure. It may have worked (in serial, randomized tests, easy to do) in New York and Brazil, but didn’t quite make the cut in our tests. Moreover, it was a black box, and gave little evidence of why it functioned the way it did sometimes. In some cases, which even the doctor mis-diagnosed, it gave stunning accuracy. But then, it was inconsistent and difficult to interpret sometimes.

The BHAD had failed. I was heartbroken. By then, the money had run out. Just as I scraping the bottom of my bank balance, I learned that I was going to be a father, and figured out I needed the stability of a job.

But that’s a separate story.

Cut to today. The industry is still the same. The population is 15 years older, and CAD remains the large malevolent silent killer it always was. The business of cardiology has grown – hugely. Indians are more predisposed to CAD given artery size and diet (amongst other reasons). Almost all ECG machines today are digital; we have a Mobile APP ecosystem – (on the App store is a 300 USD ECG App!) analytics in the cloud, Big, data and Predictive modeling are HOT. There is intense interest in the intersection of medical and mobile. 

There are now 3 – 4 companies with such a technology, all remain relatively obscure. Meanwhile the big daddies of the cardiology business haven’t yet got into this. Why?

A hypothesis that I have is that the system is simply too entrenched and profitable to drive such a revolutionary idea. The industry makes a living on the fear and misery created by the lack of an accurate screening technology. There is too much at stake. It’s like asking the Internal Combustion- based Auto industry to adopt the electric car.

But I continue to think otherwise. I ponder and plot.There is one thing stronger than all the armies in the world, and that is an idea whose time has come.

Part 1: Losing My Virginity – my first entrepreneurial leap

Part 2: Another One bites the dust. Archives from the Startup Basement