Needs and requirements for the development and application of safe and cost-efficientmedical technology in low resource settings

Abstract: Growing populations and especially the growing proportion of elderly in the developing countries in South Asia pose an increasingly higher pressure on the health care systems in these countries. For example, in Bangladesh, a part of the pressure is currently eased by the unofficial health care workers called village doctors but with the cost of wrong diagnoses and unnecessary medications leading to excess use of e.g. antibiotics. In order to help to produce a correct diagnosis and in planning the follow-up or preventive measures to improve the general health of the population, medical technology could be brought to the village doctors. Even though medical equipments are already been imported from developed countries to developing countries it has not notably improved the situation. This project has been conducted to unravel factors that affect bringing new medical technology to low resource settings, and to find outthe specific needs that countries with large rural populations but low income status have with medical technology. The purpose of this study is to investigate what demands should be placed on basic monitoring medical devices to ensure highly accurate and reliable readings, similar to those in Europe, but also an affordable product that meets the specific needs of rural health care in low income countries such as Bangladesh. This study also aims to find out what is the current need in therural areas of Bangladesh. The goal on the long run is to contribute to the development of safe and efficient medical devices that would increase the accessibility and quality of healthcare especially for the people living in the rural areas. The research questions were approached by first defining the current situation and the currenly known barriers in bringing two cost efficient medical devices for monitoring purposes to the Bangladeshi-market, and to define which requirements they should fulfil for the needs of the public health care. Secondly, European legislation was examined to research how the goal could be reached in practice. The methodology chosen for this project is qualitative methodology based on literature research and standard open-ended interviews. In addition, sensor-development work was done at KTH to study the properties of the sensors and the electric circuits. The results of this project show that, currently, medical technology is not used in large parts in South Asia such as in the rural areas of Bangladesh, but that there is a need and potential market for new devices that has not been researched before. Medical companies are aware of this, but the technology has not been developed yet to meet the local conditions. The results of this report suggest the following areas to be researched when developing new medical technology for rural areas in Bangladesh: technical requirements from an internationally acknowledged regulation (e.g. the EU regulation 2017/745 and ISO standards), reusability, robustness, user friendliness, post market surveillance, monitoring of performance and maintenance work.