Nearly half the babies born in India, especially in rural areas and small towns, come into the world outside a hospital. That’s one of the primary reasons for the high neonatal mortality rate—6.4 lakh babies die within 28 days of birth in India annually, which is nearly a quarter of all such deaths worldwide, according to a UNICEF report published last year.
A common cause of death in newborns here is lack of breathing support, and most such deaths occur during transport to hospital. This is a healthcare problem one is more likely to encounter in a third world country than in a developed nation like the US, where less than 1% of births happen outside hospitals, says A. Vijayarajan, CTO and co-founder of Bengaluru-based InnAccel, whose mission is to develop novel medical devices for India.
One of the devices InnAccel has developed is Saans, named after “breath" in Hindi. The portable device can provide continuous positive airway pressure (CPAP) support—to keep airways of patients with respiratory problems open—even to a newborn being transported to a hospital in an autorickshaw. It can run on a battery where there’s no power source. Air can be hand-pumped if the battery fails. The device, showcased at Harvard Medical School, can be hooked to a cylinder to provide extra oxygen if required.
PORTABLE and AFFORDABLE
Respiratory distress is common in preterm babies, and India tops the list with 3.5 million deaths annually, according to WHO. Most primary health centres don’t have CPAP machines. Over 50,000 newborns die in the country every year while being transported to a hospital with a neonatal ICU. Many babies who survive the journey end up with lifelong disabilities.
The InnAccel team realized that CPAP machines did not suit the conditions in which millions of babies are born in India. They spent four years to develop and test a portable, affordable CPAP device that does not require much training to use. It launched commercially in India this year and is now being evaluated in Africa. A doctor in a hospital near Bengaluru found a new use case for it when premature babies are transported from a delivery room to the ICU. “This device can have a big impact on keeping babies alive in different situations," says Vijayarajan.
LONG GESTATION PERIOD
An electronics engineer from the University of Madras, Vijayarajan worked for IT companies before moving to GE Healthcare, where he helped develop a low-cost portable ultrasound system. He joined pharma industry veteran Siraj Dhanani seven years ago to start InnAccel, which was initially conceived as an accelerator for medical device startups.
But they realized that such startups with multi-disciplinary needs and long gestation periods did not fit into a typical accelerator model. Apart from funding and guidance, founders need help connecting with hospitals, conducting clinical trials, and more. “No doctor wants to experiment on patients with a new product brought in by 20-somethings," points out Vijayarajan.
So InnAccel merged with its incubatees Coeo Labs and Sattva Medtech to become a platform where doctors, engineers and business experts could come together and be funded to develop medical devices for unmet needs. It has set up a framework to build safety and regulatory features into development from the outset instead of as an after-thought. But the biggest hurdle InnAccel helps medical entrepreneurs cross is commercialization.
Many doctors publish papers with ideas, but few take them to market. An exception is Dr Jagdish Chaturvedi, an ENT surgeon at Fortis Hospital, Bengaluru, who has co-invented 18 medical devices, including InnAccel Coeo Labs’ Saans, over 10 years.
His first device was an alternative to expensive imaging equipment to diagnose throat cancer. An endoscope attached to a small camera would be a god-send to doctors in rural areas, he thought. But after a year of working on a prototype with an engineering design firm, there were no takers or funds to make it.
It was around then he was selected for a Stanford bio-design programme, where he learnt a fundamental reason why most doctors fail as inventors.
“My endoscopy device was for somebody with my skills, not an MBBS doctor who could damage the ear, nose or throat while trying to use it," says Chaturvedi. He had put the cart before the horse. Stanford bio-design reverses that by forming a team comprising a doctor, engineer and businessperson to study a problem, and come up with a product.
Three years after he had patented it, Chaturvedi went back to the design firm Icarus in 2013 to simplify his device. Then he pitched it to Medtronic, which acquired the rights from Icarus and made the device part of its Shruti ear care programme. Today, after five years of pilot studies, a third generation Medtronic Shruti ENTraview Otoscope attached to an Android phone is available commercially.
Chaturvedi felt he needed to help create an ecosystem for innovation. He founded HiiiH, a digital platform where doctors, engineers and entrepreneurs can form teams and tackle unmet healthcare needs. While the platform is free, Chaturvedi and other experts provide paid consultancy on all aspects of medical device innovation.
EARLY DAYS FOR the SECTOR
The field is still in its infancy, judging by the mere $15.5 million invested this year in Indian medical device startups as of mid-August, compared to $2.2 billion globally, according to data tracker Tracxn. But more government grants are becoming available, and initiatives like InnAccel and HiiiH raise the prospects of success to kickstart what could have a major social impact.
For instance, ventilator-associated pneumonia (VAP)—pneumonia that develops after a patient is put on ventilator support—takes 2,50,000 lives in India each year. The main cause for VAP is that nurses are unavailable or not trained to remove saliva that trickles into the lungs.
InnAccel’s VAPcare manages the secretion of saliva in ventilated patients. Patents have been granted in the US, China and India, and are pending in Europe. “There’s a worldwide requirement because there is no such product in the market," says Vijayarajan.
Challenges are many, from finding the right product-market fit to getting a sufficient runway to fly with it. Even those that get traction mostly do cheaper Indian versions of devices developed abroad. Some promising ones like Perfint—a startup that developed robotic systems for interventional procedures in cancer treatment and surgery—appear to have miscalculated the time and cost for commercializing expensive products.
But the potential is huge with 75% of medical devices in India being imported. They’re not only costly but aren’t designed with Indian problems in mind. The massive healthcare problems in the country also create opportunities for innovations that could be taken to global markets.
