Consure Medical is committed to developing a solution that solves the problems inherent in existing fecal incontinence treatments yet is simple enough for a motivated family member to use. With guidance from top doctors at the All India Institute of Medical Sciences (AIIMS), the team developed an indwelling device similar to a short-term implant that offered multiple advantages over available treatment options.
With a working product in hand, the cofounders’ next challenge was to determine a testing strategy that would validate the safety and efficacy of the device and support the company’s regulatory strategy. With immediate opportunities to sell the product in India, as well as a larger global market to pursue, the team needed to think broadly about its clinical and regulatory approach. Consure wanted a plan that would give it license to operate in multiple geographies along with credible evidence to support adoption in multiple settings. This mini-case study looks at the factors Consure Medical considered in defining a plan, as well as the approach the company ultimately defined.
This story is part of the Global Health Innovation Insight Series developed at Stanford University to shed light on the challenges that global health innovators face as they seek to develop and implement new products and services that address needs in resource-constrained settings.
Acknowledgements: We would like to thank Nish Chasmawala of Consure Medical for his participation. This research was supported by the National Institutes of Health grant 1 RC4 TW008781-01.