Fecal incontinence (FI) or commonly referred to as bowel control problem, is a condition in which there is a loss of regular control of the bowels. Involuntary excretion and leaking are common occurrences in the affected individuals. The condition is prevalent in 18-33 percent patients in acute or critical care settings, 46 percent patients in long-term care at hospital, and three percent along elderly patients in residential and nursing homes. Consure Medical, a New Delhi-based start-up which started operations in 2011, has developed a novel, disruptive solution to address this unmet clinical need which is assumed to benefit more than 16 million patients in India and over 100 million worldwide.

Mr Nishith Chasmawala, co-founder, Consure Medical mentions "FI is un-glamorous. Nobody talks about the problem. It is psychologically stressful to the patient and a major source of embarrassment to the family. We have developed a novel solution that will enable a family member to care for their loved ones in a dignified and hygienic manner. Our device is odorproof, leakproof and works across multiple clinical settings. We have replaced yuckiness with compassion and dignity."

The solution for FI was developed by three fellows at Stanford-India Biodesign: Dr Sandeep Singh (faculty at AIIMS), Amit Sharma and Nishith. During their fellowship, the team identified over 300 unmet clinical needs of India that needed attention. Through a comprehensive filtering process, the team decided to work on the FI problem. Mr Nishith recalls, "we did not set out to address a $7 billion reverse innovation challenge. Once the problem was identified and well defined, we set out to adress this latent need. Medical device product development and commercialization comes naturally to us. We spent a lot of time doing clinical validation, market segmentation, IP landscape and last but not the least - how to develop a product in India where the medical device ecosystem is very nascent and severely fragmented."

After the idea and concept generation, the team built over 100 prototypes of the device to evaluate different concepts and gather preliminary subjective evidence. Mr Nishith highlights "we were lucky to be based out of AIIMS during this phase of development. Medical device development is an iterative process and getting real time feedback from some of the brightest clinical minds of idea was extremely vital."

Talking about the formation of Consure Medical, Mr Nishith says, "after almost 15 months of iterative development and bootstrapping, we felt we had reached the escape velocity to go to the market and raise funds. Amit Sharma and I co-founded the company in 2011. Dr Sandeep Singh continues to practice cardiology at AIIMS and finds time to help us out with clinical trials and other stuff."