faculty

Publications

A structured process for unmet clinical need analysis for medical device innovation in India: early experiences

Groups and Associations agdish Chaturvedi,1 Andrew Logan,2 Girish Narayan,3 Shakuntala Kuttappa
BMJ Innov 2015

ABSTRACT It is estimated that approximately 75% of medical devices and diagnostics come to India from imports. A WHO report on medical devices highlighted that most devices present in developing countries have been designed for use in developed countries. Consequently, when these medical devices are implemented in India, they are either unaffordable or are maladapted to fit the complex healthcare ecosystem. A strong need exists to develop technologies that are intentionally designed to suit the Indian healthcare system. To address these issues, we have applied a modified version of the biodesign process, originally developed by Stanford University, to identify unmet clinical needs in the field of emergency medicine at a tertiary referral hospital in southern India. Since the biodesign process was originally created to identify unmet needs in a more mature Medtech ecosystem, we have altered its implementation to make it more suitable to the evolving Medtech ecosystem that prevails in India. At the completion of 2 months of clinical immersion by a multidisciplinary team, 100 unmet needs with significant negative outcomes were identified. The team then took all the need statements collected during the period of the clinical immersion and applied four rounds of precalibrated filters to arrive at the top 10 most compelling clinically validated needs that would be selected for the phase of invention. In this article, we present our reasons for making modifications to the biodesign process, our results and our experiences while implementing this process in an Indian healthcare system. INTRODUCTION 75% of medical devices and diagnostics used in India are imported.1 A WHO report on medical devices highlighted that most devices present in developing countries have been designed for use in developed countries.2 Consequently, when these devices are implemented, they are either unaffordable or are mal adapted to fit the complex healthcare ecosystem that exists in many developing nations.3 In western countries, medical technologies are evaluated using a struc tured health technology assessment (HTA), which is defined as the “system atic 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”. This assessment helps ensure that all stake holders are considered in the implementation of medical devices.4 Because its medical technology ecosystem is still in its infancy, India does not yet have a formalised process to carry out such evaluations.5 One must also consider that 60–80% of healthcare in India is delivered in the private sectors, with close to 80% of the population paying for health care out of pocket.6 This limits the impact of insurance coverage decisions on devices and makes the implementation of expensive medical procedures diffi cult.7–9 These factors have contributed to a lack of implementation and develop ment of medical devices tailored for the Indian healthcare system.