Case Studies of Innovative Medical Device Companies from India : Barriers and Enablers to Development

Given that medical devices in India tend to be imported (75%), it is important to understand local attempts at innovation in this space. Based largely on interviews, we have prepared case studies of six local innovative device companies. The innovators' efforts have been enabled by close linkages with doctors, with awareness of scientific and technological advances internationally and with trying to meet the regulatory requirements of Western nations. Some of the challenges they face include the lack of product specification guidance by the Indian regulators or institutional health care payers and the absence of Health Technology Assessment. Some of the steps that would help include a larger and better equipped national regulatory body, medical guidelines that facilitate market assess of innovative products, continuous medical education, institutionalized health care payers and so on. The firms are pioneering, and have brought out (or will bring out) products that are relevant to the sometimes difficult conditions that prevail in the country