In the case of drugs, due to its strong reverse engineering skills, India is virtually self-sufficient. In contrast, 75% of the annual purchase of devices and diagnostics comes from imports
. A WHO report on medical devices pointed out that: “almost all devices present in developing countries have been designed for use in industrialized countries”
. Consequently, they are often unaffordable and are maladapted to low resource settings.
Whereas rural health care providers are a documented source of grassroots technical innovation on a micro scale
 the private industry world-wide has valuable expertise in the development of medical devices for mass use
. However, the industry has traditionally perceived that developing-world markets are too small to justify the development of new products
[2, 4]. Thus, over the past decade, a number of push and pull incentives have been proposed by international public health organizations, non-governmental organizations (NGOs) and donors in order to incentivize the western industry to undertake research and development (R&D) addressing the specific needs of the developing world
[4, 5], although market access challenges of this industry in such markets have been well-documented
. More recent is health technology innovation, largely by young companies located in developing countries, where the companies perceive local markets as the main focus of their R&D strategy
Important to health technology innovation is Health Technology Assessment (HTA), defined as the “systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision making regarding health technologies” (http://htaglossary.net). In industrialized countries, there is a growing interest in interactions among bodies concerned with HTA, coverage (institutional purchasing or reimbursement), and regulation with whom the industry needs to engage in order to develop novel products that can reach patients
. Improving such interactions is believed “to speed patient access to valuable products” and “to remove unnecessary barriers to successful development and appropriate market access for innovative products”
In contrast, India doesn’t have a formalized national HTA process and the public financing of new technologies is very limited
. Whereas 60-80% of health care is delivered in the private sector, only 3-5% of the population has health insurance
 so coverage decisions by insurers have negligible impact on the market uptake. Further, medical practitioners in the private sector are not obliged to follow any official evidence-based guidelines, and continuous medical education is not mandatory
[12–14]. Finally, the regulation of medical devices is minimal: in the case of in-vitro tests, only those for HIV, hepatitis B and C and blood typing are considered 'critical’ by the Indian regulator and only these tests must be clinically validated before receiving a license. In this context, our study aimed to provide qualitative insights into the frugal innovation experience of companies that function in an environment that doesn’t have a tradition of indigenous novel bio-medical product development.
Here we present case studies of six private companies in Bangalore, India, that have developed and launched (four cases) or are expecting to soon launch (two cases) devices for the Indian market. These firms belong to a new wave of intellectual property (IP)-based product ventures in the country. We study (i) the evolution of the firms and their approaches to product development; (ii) their funding and human resource challenges; (iii) their access to global science and technology (S&T); (iv) their use of global regulatory requirements, and finally (v) the market challenges that must be overcome in order to access patients with their products. We believe that insights from this study will be of interest to many young companies, regulators and policy makers in the world.