Critical elements in the design, development and use of medical devices / العناصر الحاسمة في تصميم وتطوير واستخدام الأجهزة الطبية

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

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.

Public interest abstract: The paper reviews the factors that influence the development of medical devices in general and orthopedic devices in particular. Focusing on low- and middle- income countries which tend to rely on medical devices and donations, the study advocates for the need to address context-oriented challenges that interfere with usability and compatibility, such as lack of electricity to operate the technologies and spare parts for maintenance.

To minimize these problems, it is imperative to consider the prevailing conditions of developing countries in their broad context in order to customize the medical devices and enhance their usability.

This study illustrates by means of examples the initiatives that can be adopted to facilitate collaboration between developing and developed countries for their mutual benefit.

The study is useful to policy makers, local and international producers of medical devices and other stakeholders as it illuminates the importance of context in the production of medical devices.