In Low and Middle-Income Countries (LMICs), a significant challenge lies in the misalignment between available medical equipment and the specific needs of these regions. For example the needs of being adapted to low resource settings. A lot of medical equipment is not adapted to be operated in low-resource settings. This situation has prompted a growing interest in seeking comprehensive solutions that ensure clinical safety, adaptability to local needs, and affordability with the available resources. Previous strategies have had limited success, as they primarily focused on isolated aspects such as providing extra training or ensuring spare parts and leaving medical equipment unused or non-functional. Presently, a global team of experts is actively exploring the potential of an innovative solution – the "Appropriate Medical Equipment" (AME) label. The idea of this team of experts is to develop such a label so that those who are purchasing equipment know that the equipment is appropriate for the LMICs settings. Because, often, equipment is donated or funded by external organizations with procurement processes that prove inappropriate and ineffective. The unused and non-functional medical equipment contributes to critical issues, adversely impacting the functionality, usability, and lifespan of medical equipment, thus impeding its vital role within the healthcare system. Therefore, this research will delve into the requirements and characteristics necessary for developing this new product label, considering the perspectives of experts related to LMICs.\\
The research addressed four sub-research questions that collectively provided answers to the main research question: \textbf{\textit{"What characteristics of an Appropriate Medical Equipment label would facilitate the intended use of medical equipment in low- and middle-income countries?"}} To answer the main research question, a design approach was employed, proving to be a valuable problem-solving method for this multifaceted problem. The design approach encompassed four phases: exploration, ideation, prototyping, and prototype review. In the exploration phase, four key steps were undertaken. Firstly, a literature review was conducted to investigate the current usage and experiences related to labels and certificates for medical equipment as well as labels in general, with a focus on experiences pertaining to medical equipment labels and certificates. Secondly, scientific literature was used to identify system factors influencing the life cycle of medical equipment. Insights from this literature were translated into IDEF frameworks, which formed the foundation for subsequent interviews. These IDEF frameworks served as structured way of showing information and were used as boundary objects throughout the research and interviews. Thirdly, interviews were conducted with experts, validating the information obtained from the literature and enhancing the IDEF framework. The fourth step was consolidating the insights to formulate a problem statement. This problem statement encapsulated key stakeholders' needs, requirements, desires, and dilemmas. Following the accumulation of knowledge from the exploration phase, the ideation phase began. During the ideation phase the design space matrices were developed for each of the categories. This design space matrix showed the decision making process between categories and means. The third phase, prototyping, involved synthesizing the knowledge gathered from the previous phases to create a prototype. Lastly, in the review prototype phase, the prototype was discussed with experts who provided feedback and opinions. Following the prototype review, consideration was given to future steps, determining the best approach for addressing this complex problem.
The study concludes that to facilitate the intended use of medical equipment in LMICs, a product label should incorporate essential characteristics, identified through a comprehensive review of literature and expert interviews. These characteristics encompass safety, design orientation, training, finance, maintenance, spare parts, service, usability, transparency, and end-of-life considerations. By prioritizing and integrating these features, the label has the potential to indirectly improve the overall life cycle of medical equipment in LMICs. The requirements for such a product label are identified through expert interviews, encompassing training, technical aspects, and safety considerations.
Beyond individual characteristics of the label itself, this study also explored the success of label implementation for medical equipment in LMICs. Several concerns require attention for a successful label implementation. The concern covered in this research is the potential misalignment of values and agendas among stakeholders can hinder commitment to a new product label and its prototype. To address this, incentives should be tailored to meet the specific needs of each stakeholder. Research indicates a preference for the bottom-up approach in label development due to its effectiveness in managing complexity and enhancing project success rates. Starting with end-user testing and progressing upward to demonstrate the label's value and encourage adherence to its standards can motivate manufacturers. By integrating the label's unique characteristics with advocacy efforts and a bottom-up approach, it has the potential to facilitate the intended use of medical equipment in low- and middle-income countries, enhancing the crucial role of medical equipment in healthcare systems in these regions.
The findings in this thesis hold significant importance for individuals seeking solutions to reduce the high rates of unused or non-functional medical equipment in LMICs. This thesis explores the distinctive characteristics of a label and how these characteristics can address the challenges present in the medical equipment life cycle. By gaining a clear understanding of these issues, organizations and experts can leverage these insights when developing solutions to reduce high percentages of unused and non-functional medical equipment, such as the product label. Lastly, the thesis introduces an initial prototype for a product label for medical equipment in LMICs. This prototype is a start for future study and can be used as a starting point for the actual development of the product label.