Every year, over 8 lakh babies die of asphyxia. Of that, 2 lakh are in India alone. Birth asphyxia occurs when a baby doesn’t receive enough oxygen before, during or just after birth. Sadly, it’s more common that one may think. Five out of 100 babies require resuscitation or artificial/device-aided breathing, without which they can either fall prey to disabilities or death. “It’s the third largest cause of newborn deaths, despite the fact that many of them can be avoided,” says Avijit Bansal, co-founder and CEO, Windmill Health.
It’s not like there aren’t enough solutions. The conventional bag mask costs less than 5,000. But visiting public health centres across India, Bansal found that there was a massive gap. “What shocked us was that there was a serious skill barrier to resuscitation. Many studies show that even skilled persons are not able to perform it properly.”
The conventional bag mask is a simple device — a rubber bag with a nose mask attached at one end. The mask is to be placed over the patient’s nose and mouth and pressed to create a seal. Then, the rubber bag is to be pressed to generate air. But herein lies the predicament. “It’s very hard to generate a seal and the right amount of pressure together, especially since one can’t use the stethoscope as both the hands are busy,” says Bansal. That’s what Windmill Health is trying to solve with NeoBreathe.
It was probably an incident from his childhood that led Bansal into resuscitation in the first place. When you are 12, and see a kid of your age collapse suddenly, it is bound to leave an impression. “I saw my parents bring him back to life,” he says.
With his parents being doctors, MBBS was the easy option. But Bansal later specialised in pulmonology. “At the Vallabhbhai Patel Chest Institute, we would resuscitate newborns with the bag mask. Those were anxious moments. Both your hands had to be used to create pressure — there was a child’s life at stake,” recalls Bansal.
Even then, Bansal thought there had to be a better way to do this. In 2011, at the Stanford-India Biodesign fellows, he met Ayesha Chaudhary, who was also researching the subject. “We chose newborn resuscitation as a way to empower care-givers,” says Bansal.
The solution was staring right at them — if it was difficult to perform both the tasks (generating the seal and air), one of them had to be delegated. That’s exactly what they did. NeoBreathe is a pedal-run resuscitation device. Here, the mask is placed over the patient’s nose and mouth just like the bag mask, but the difference is that the air is generated from the foot pedal. The other problem with the bag mask is that any movement could destabilise the seal. By distancing air generation to a pedal, away at the floor, this was solved too.
But there were other inherent problems. “Some babies need oxygen. And it needs to be measured, since excessive oxygen can result in blindness,” says Bansal. Besides, some may need suction before resuscitation, a facility that is not easily available at public health centres. Then, there is positive end-expiratory pressure (PEEP)- a technique to assist breathing by increasing the pressure in the lungs at the end of air expiration-which is only available in the much costlier T-Piece resuscitator. With NeoBreathe, the duo ensured that all these things were taken care of. The product, thus measures oxygen levels, provides suction and is also a PEEP provider.
While Chaudhary is no longer with Windmill, Bansal says, the device, which saw a limited release recently, is more efficient in resuscitating newborns. “There is an improvement of 20% in air volume — both by a first-timer and an experienced practitioner.”
In the development phase, Bansal says, “We got a lot of help from the Department of Biotechnology (DBT), which holds the IPR of the product.” Windmill has a license from the department to retail NeoBreathe.
Dr. Balram Bhargava, executive director, Stanford-India Biodesign Centre (under DBT), where the company was incubated says, “It’s a novel device, the first with a pedal, and can go a long way.” Moreover, he adds, the device marks a shift. “Around 85% of the medical equipment is still imported from outside. We have been making some class 1 and 2 devices, but now class 3 devices are also being developed in India.”
That was Bansal’s idea too, but NeoBreathe still imports a lot of its parts. “We work with manufacturers who specialise in precision instrument making,” says the co-founder, adding that the start-up has no plans to manufacture parts in India for now. “Our mission is to innovate and come up with solutions that have an impact on the global health industry, and create a precedence in India,” he adds.
But that is easier said than done. Bhargava would know better. Stanford-India Biodesign Centre has been incubating medical technology start-ups. “A medical device’s gestation/development period is around seven years, unlike 15 years for medicine,” he says. Windmill, thus, needed funds at every stage. Recalling his journey in 2013, Bansal says, “We were lucky to get funding from the Bill & Melinda Gates Foundation.” This was followed by a grant from a mini-PSU, Biotechnology Industry Research Assistance Council (BIRAC). They were also supported by US India Science and Technology Endowment Fund which has constantly supported the venture and has been their single largest donor.
The funding paved the way towards recognition. “We got visibility. On her visit to India, Hillary Clinton saw NeoBreathe and mentioned it in her speech,” says Bansal. The company has also seen investment from Villgro and a Canadian government fund. “Most of the funding came in the year 2013 and amounted to around $700,000,” reveals Bansal.
Most of the funding, Bansal says, has gone into testing the product on parameters such as pressure, volume and in risk assessment. “The rigorous testing is in line with the standards adopted in 13 countries,” he adds. While the device doesn’t need any certification, Windmill, nevertheless, has got European certification.
Bansal is hoping that the certification and its association with AIIMS will give it credibility. The deep entrenchment of existing medical devices, however, will be hard to break. “The bag mask has been used for several decades. The shift will take time,” acknowledges Bansal. But he adds that once the device is out on the field and hospitals notice the benefits, NeoBreathe will take off.
The device is already being tested in seven states — UP, Gujarat, MP, Tamil Nadu, Bihar, Karnataka and Andhra Pradesh. “We are doing a pilot with the MP government. Then, we plan to leverage our extensive network and forge partnerships with experienced players and institutions in this space,” says Bansal.
Windmill is planning to do a commercial launch by the end of this year. “We already have orders after testing. Both government and private hospitals have shown good amount of interest,” reveals Bansal. The start-up also plans to export NeoBreathe to other countries next year.
But what about the price? While the price of a conventional bag mask can be 2,000 to 3,000, a sophisticated resuscitator costs 60,000. “The price point will be between these two,” says Bansal without revealing the actual figure. Bhargava, who won a Padma Shri for his pioneering efforts in medical technology in India, says this will be crucial for NeoBreathe to succeed. “It has to be an Indian price, not a global one if it has to work,” he cautions. Considering that there are 2.2 crore births per year in India alone, the potential, indeed, is huge. After all, who doesn’t want to breathe easy?