Critical elements in the design, development and use of medical devices. A systemic perspective of orthopedic devices landscape in low- and middle-income countries

Abstract

Objectives

The paper reviews the critical elements in the design and development of medical devices in general and orthopedic devices in particular as well as illustrates by means of examples the initiatives that have been put in place to incorporate contextual factors in low resource settings. Methods

Data was collected by means of a targeted literature review from different databases using key terms. The search was done using combinations of key terms namely ‘medical devices’, ‘low- and middle-income countries’, ‘high income countries, drivers of innovation’, ‘technology transfer’ and ‘local production’. Results

The study yielded five critical elements which are indispensable in the development of medical devices. It emerged that the context of use, by virtue of encompassing the stakeholders, geographical space and medical devices provides a vantage point for addressing the complexities in the development of medical devices in low resource countries. The paper argues that approaching the critical elements from a contextual standpoint provides a systematic perspective for developing medical devices that are customised to the prevailing environments in low- to middle- income countries. Conclusion

With the growing markets for medical devices, the review highlights the importance of forging strategic alliances between high income and low- to middle- income countries in developing appropriate medical devices for the users. The paper contributes to the policy discourse targeting both local and foreign manufacturers of medical devices as well as stakeholders from the public sector, industry and not for profit organisations on the importance of contextual awareness in the development of technologies.