In a few months, a low-cost medical device in Delhi that tackles fecal incontinence - a neuromuscular disorder where patients are unable to control their bowel movements - will complete its second and last clinical round of trials.
If Consure, the company responsible for this one-of-a-kind device, is successful, it has a shot at being one of the few global players with an ingenious low-cost solution targeting a $4-billion (Rs 24,000-crore) global industry with 100 million patients, 16 million of whom live in India.
However, the most startling aspect of Consure's device is that it wasn't invented by General Electric's health wing or a top Indian hospital or even a leading researcher in the field of fecal incontinence. It was the result of a novel way of bringing leading engineers and doctors together and giving them a good dose of problem solving for the health arena.
The Stanford India Biodesign programme - a joint venture between Stanford, All India Institute of Medical Sciences (Aiims) and Indian Institute of Technology (IIT)-Delhi - was started in 2007 by Balram Bhargava, a cardiologist at Aiims, who himself was something of an inventor having spent significant time experimenting with low-cost stents in the past. Four or five fellows are chosen every year, awarded $3,000 a month for their six-month Stanford stint by the Indian government and shipped off to California. They spend the first three months understanding the world of medical technology devices at the university while the next look at business models the world of venture financing.
In just six years, the programme has churned 12 low-cost medical devices, generated 25 patents with five still in stages of clinical trial. BioScoop, for instance, is a revolutionary device for liver biopsies that uses needle aspiration technology that significantly lowers the chances of post-procedural bleeding. "India has the potential to become a world hub for low-cost medical device design," said Paul Yock, managing director of Stanford's Biodesign department and a Stanford professor of bioengineering, in an article published by the university's school of medicine. Hillary Clinton, former US secretary of state, was apparently impressed last year by Neobreathe, a neonatal resuscitation device, which has come out of the programme.
Relligo is a novel solution for victims of traffic accidents in India. It has a deceptively low-end solution: A cardboard plank with five Velcro straps along its length; when the sides are folded up, it becomes rigid enough to immobilise a leg over an ambulance ride. Cost? Rs 250 versus the most commonly-used ones costing close to Rs 2,000. Plus, most stints are metal which don't allow the leg to be X-rayed, but Relligo doesn't have that problem. MIT Technology Review India honoured Nayak as a 'Top Innovator Under 35 in India' for his invention and Hindustan Latex plans to distribute the product across the country.
Industry observers say the biodesign programme could have important ramifications for the Indian health sector. One, the Indian market is grossly underserved and any product aimed at a debilitating disease that is available at a significantly cheaper cost is literally a life-saver. Two, inventing medical devices is incredibly difficult where funding risk is the highest. "A medical product device not supposed to work out," says Nishith Chasmawala, co-founder of Consure. This is because of not just the larger funds involved in starting a product company but also because of medical and regulatory risks.
Perhaps, the reason why the process is working so well is because of the inherently inter-disciplinary effort that the programme calls for. The Consure team, for instance, is made up of a plastics engineer with significant business and entrepreneurial experience (Nishith Chasmawala), an industrial designer from IIT-Delhi (Amit Sharma) and a cardiologist (Sandeep Singh). "It's fantastic way of learning from each other," says ENT (ear, nose and throat) specialist and inventor of the liver biopsy device Jagdish Chaturvedi who now works as a consultant for the programme.
When fellows return to India, they begin shadowing doctors at Aiims and start internalising the 500-600 unmet clinical needs in patients. This involves going from the OPD (outpatient department) to the Cath Lab to surgical suites to the trauma centre at Aiims plus a host of rural and district level hospitals. The idea is to simply record observations. With significant time under one's belt, the process of filtering these observations through all the various parameters imbibed from the Stanford experience begins with an eye on choosing one that has scale and the possibility of a low-cost solution.
Teams have a way of then organically forming as like-minded fellows gravitate towards each other. Then, the process of figuring out a solution begins. "We started with a 1,000 possible solutions for the fecal incontinence problem, boiled it down to 300, and then finally arrived at one," says Chasmawala. This is the most intense part of the process as doctors, engineers and designers debate each other in figuring what can and cannot work.
When the combination clicks, it results in radical, new products that can save lives and make money for its founders.
- The Stanford India Biodesign programme has churned 12 low-cost medical devices and generated 25 patents, with five still in stages of clinical trial.
- A low-cost medical device that tackles fecal incontinence, a neuromuscular disorder where patients are unable to control their bowel movements
- BioScoop (bottom left), is a device for liver biopsies that uses needle aspiration technology to lower the chance of post-procedural bleeding
- Neobreathe is a neonatal resuscitation device
- Relligo (left), for victims of traffic accidents, has a cardboard plank with five Velcro straps along its length. When the sides are folded up, it becomes rigid enough to immobilise a leg over an ambulance ride