Open Issues and a Proposal for Open-source Data Monitoring to Assure Quality, Reliability, and Safety in Health Care Devices Targeting Low- and Middle-income Countries
Health care entrepreneurs who design medical devices and mobile health applications for emerging markets face difficulty when deciding how to demonstrate the safety of their products. Many middle and low-income countries have no uniform system to address safety. This paper presents findings from 40 interviews with stakeholders involved in device development. It illustrates multi-stakeholder perspectives on quality, reliability, and safety (QRS) issues for health care devices designed for low- and middle-income markets. The paper identifies key challenges for entrepreneurs in these markets. Then, it proposes an open-source technology approach to build a transnational QRS assurance system. Further research is needed to determine whether and how open-source technology could enable an easy-to-use, effective, and affordable QRS system for health care devices in emerging markets.
KeywordsSocial Entrepreneur Stakeholder Perspective Frugal Innovation Medical Device Development Health Care Device
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