New Delhi: For any standard anaemia test, you can’t avoid a finger prick, however quick and fleeting the pain may be.
But thousands of women die during childbirth in India every year because they lack access to any sort of haemoglobin screening during pregnancy, a standard procedure for checking iron levels in blood to detect anaemia. Or, because they refuse to be pricked—due to an irrational phobia of blood being drawn from their bodies, leaving anaemia to go undetected.
A fledgling medical device maker based out of Thane, Maharashtra, claims it has the answer: a non-invasive method of monitoring one of the most rampant health problems caused by a decrease in the quantity of the red blood cells in India and much of the developing world.
Doorstep service: Abhishek Sen (extreme left) and Myshkin Ingawale test a woman’s haemoglobin count in Thane, Mumbai.
Biosense Technologies Pvt. Ltd says it has developed a portable gadget—ToucHb—to estimate the haemoglobin count.
Instead of a needle jab, a person would be required to wear a finger probe, embedded with tiny diodes that send light signals to a case not bigger than an iPad to measure the haemoglobin. The results can be assessed under one minute.
The product, awaiting patent, is expected to undergo field trials soon in Karnataka and Rajasthan for which it’s in talks with Biocon Foundation, run by India’s biggest biopharmaceutical company Biocon Ltd, and Action Research and Training for Health (ARTH), a not-for-profit organization.
Last month, Biosense received seed funding from Villgro, a Chennai-based organization that supports early-stage social enterprise. Villgro declined to disclose the amount, but says it will commit further investments to lift the project to a commercial stage.
Most investments in the healthcare sector typically go to projects that are in the late stage of development. While there’s a deluge of treatments available in India, backed by medical expertise and super specialty hospitals, there’s a scarcity of cheap screening facilities for a vast majority of the poor, according to Reihem Roy, portfolio manager at Villgro.
“We are seeking a low-cost healthcare screening indigenously designed for India and Biosense, which is targeted at maternal health, has a huge potential for market,” Roy says.
The idea of developing ToucHb was sown in 2008 when five young, energetic entrepreneurs—three doctors, one car designer and a financial consultant—all friends in their mid-20s and early 30s, began to explore whether they could blend their experience to make a tool that could make a social impact—and little money too.
The idea struck doctors Abhishek Sen and Yogesh Patil while they were medical students at Mumbai’s Nair Hospital. They saw severely anaemic women wheeled into emergency wards, bleeding to death. The team spent time observing pregnant women in Parole village, 2 hours from the city.
They found that many women hadn’t tested for anaemia several months into pregnancy, risking having stillborn, pre-term or low-weight babies.
It’s a vicious cycle, according to Sen, who also has a biomedical engineering degree from the Indian Institute of Technology (IIT), Bombay.
“If the mother is severely anaemic, there’s a high chance she will die. And if the baby survives and is a female, there’s a chance she will grow up to be anaemic,” says Sen.
But like most ailments, diagnosis of anaemia remains one of the country’s biggest community health challenges, particularly when test labs are out of reach for a majority of rural women.
The facts are already known. An average 221 out of every 1,000 women die during childbirth in India, one of the world’s worst track records. Risks of death multiply due to anaemia, and iron deficiency is the most common among its many symptoms.
While children and men too are affected, anaemia among pregnant women between ages 15 and 49 has risen sharply between 1989 and 2006, from 50% to 58%, according to the National Family Health Survey.
In the absence of labs, India prescribes a century-old tool called Sahli’s haemoglobinometer as a “point of care” diagnosis in rural areas, training an army of auxiliary nurse midwives to provide the service. The technique involves diluting the blood sample with a chemical solution, then matching it to a colour-coded glass piece, much like matching blouse or petticoat shades to a sari.
The World Health Organization, in 1995, came up with its Haemoglobin Colour Scale; it compares blood samples against a printed catalogue.
According to maternal experts, both the tests leave a margin of error and are not fully capable of making readings correctly.
In Sahli’s case, results could vary according to the angle of light, throwing up different values at different times of the day. Gynaecologist Kirti Iyengar, board member of ARTH that runs health centres in Rajasthan, says Sahli’s has another serious issue; the government-trained nurses aren’t sufficiently trained to keep their equipment clean, posing infection risks.
In 2009, doctors at New Delhi-based All India Institute of Medical Sciences (AIIMS) compared the two out-of-lab standards in a report; it found that a standard Haemoglobin Colour Scale was even less “efficacious” than Sahli’s.
India needs a device that health workers can use easily, one that can detect mild to severe anaemia, Renu Saxena, AIIMS’ haematology head and one of the writers of the AIIMS report , says.
So, the Biosense team began to brainstorm their idea. First, Sen and Patil, who also went for a management degree at IIT-Bombay, began talking innovation. Technology inputs came from Aman Midha, an industrial design graduate from IIT-Delhi who once fancied sculpting luxurious products, serving as car designer with Tata Motors Ltd.
The three chucked their jobs and moved into a flat in Thane, 40km from Mumbai. Myshkin Ingawale, with a management degree from the Indian Institute of Management (IIM)-Calcutta, came on board after giving up a consultancy career at McKinsey and Co.Darshan Nayak, a Stanford India Biodesign fellow currently working in AIIMS, is the fifth partner.
Their rented flat doubled as a lab, where they drew “complex algorithm models” to build their proprietary software. They shopped for electronics at Mumbai’s Lamington Road, and their first circuitry demo was inside a yellow tiffin box. Some of them pricked themselves 20 times over to test their model against existing clinical standards. They ran “in-house trials” on friends who dropped by.
“To validate, we had come up with 10 variants. The product has to be credible,” Patil says of ToucHb, currently undergoing clinical trial at Nair Hospital.
In 2009, the project received its first seed funding of Rs 5 lakh from the Centre for Innovation, Incubation and Entrepreneurship (CIIE), set up by IIM-Ahmedabad and the government. It won the government’s TePP (technopreneur promotion programme) grant of Rs 12 lakh, which eased their survival worries.
The idea also created a flutter of excitement in the international social innovation circuit when it won the $90,000 (around Rs 46 lakh today) Echoing Green fellowship in New York last year. CIIE has a small stake in Biosense. Villgro may also take equity in the company.
“Fundamentally, the whole chain has to make money to make the product sustainable,” reasons Ingawale.
The aim of Biosense then is not just to make a device that’s inexpensive, but one that frees the need of technicians for faster doorstep service by rural health workers. But any new discovery has to be first tested against the gold standard—lab auto analysers capable of detecting anaemia accurately.
ToucHb currently has achieved 82% accuracy against auto analysers, bettering Sahli’s record of 65%. The team is currently fine-tuning its product. For purposes of active surveillance, it’s also trying to find out whether the ToucHb software could electronically store and transfer data—like from a mobile phone to a Web address.
Talks are also on with an international organization to undertake field studies in Nicaragua or Kenya. They have another worry: whether the device—designed small for convenience—would encourage theft.
An appropriate diagnostic tool will not just reduce healthcare costs, but will shape how treatment with better diagnosis can reach the masses. The idea, says Sen, is to make ToucHb—which can also measure oxygen saturation—as common as a blood pressure instrument, and if possible, extend its utility to other chronic ailments.
“It would be satisfying if that happens,” says Sen.