Abstract
BackgroundThis study characterized the landscape of commercially available medical devices specifically designed for use in low-income countries (LICs).MethodsA state-of-the-art review of peer-reviewed publications, patents, global health databases, and online resources was performed. The criteria established for a health technology’s inclusion in the study were: it met the definition of a medical device; it was designed and developed to address one of the top ten causes of death in LICs, Millennium Development Goal (MDG) 4, or MDG 5; and there was evidence of its commercialization.ResultsAnalysis identified 134 commercialized devices exclusively designed for use in LICs. More than 85% of devices were designed to address infectious diseases or child or maternal health (MDG 4 or 5, respectively). None of the identified devices addressed prevention of noncommunicable diseases (NCDs). Only 8% of devices were designed for use in primary health facilities by non-physician health providers.ConclusionThere is a significant mismatch between the projected global burden of disease due to NCDs and the relevant number of commercialized medical devices designed specifically for use in LICs. A limited number of commercialized devices were designed for use by non-physician health providers. These findings suggest the need for medical devices targeting NCDs in LICs and design processes that consider the broader context of design and engage stakeholders throughout all phases of design.
Highlights
This study characterized the landscape of commercially available medical devices designed for use in low-income countries (LICs)
Medical devices are acquired through technology transfer: local production of devices that resemble technology designed for use in high-income countries (HICs) or the low-cost sale of older models of devices originally designed for use in HICs [5, 6]
The role of medical devices and health technology in the fight against noncommunicable diseases (NCDs) was emphasized in the Global Action Plan for the Prevention and Control of NCDs proposed by the World Health Organization (WHO) and endorsed by the World Health Assembly in 2013 [23]
Summary
This study characterized the landscape of commercially available medical devices designed for use in low-income countries (LICs). The availability, accessibility, and effectiveness of medical devices are vital in achieving the highest quality of care within health systems [1]. The overwhelming majority (~ 90%) of health technology sales have occurred within high- and middle-income countries [3, 4]. Almost 80% of medical devices in LICs are acquired by donation [5]. Medical devices are acquired through technology transfer: local production of devices that resemble technology designed for use in high-income countries (HICs) or the low-cost sale of older models of devices originally designed for use in HICs [5, 6]. Use of medical devices in LICs that were originally designed for use in HIC are
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