Medical equipment supplied to low- and middle-income countries (LMICs) are often substandard and inappropriate to the contextual needs. The majority of equipment entering these countries are donated or financed by external agencies. Procurement of equipment also happens through public tendering. However, the assessment and management of the equipment entering these countries are found to be inappropriate and ineffective. This has resulted in equipment that remains unused, malfunctions, or fails to meet its expected lifespan. This ultimately causes harmful consequences to the patient groups in LMIC. It is high time that this situation needs to be addressed and implement measures to provide quality, safe, affordable, accessible, and appropriate health technologies to people in these low-resource settings. One approach to create transparency around the notion of appropriate health technologies for LMICs is by creating a set of measurable criteria, tested in the form of a label. A global team of BioMedical engineers undertook an initiative to implement such a label, namely, ‘Appropriate Medical Equipment’ or ‘AME Label’. This research aims to examine the feasibility and constraints associated with implementing such an initiative from the perspective of medical equipment manufacturers.

The study investigated four main topics to answer the research question: ‘How can a new product label support medical equipment manufacturers to sustainably enter the healthcare market of low- and middle-income countries?’. These are the value of product labels in the market, regulatory challenges faced by manufacturers in the MedTech industry, challenges for manufacturers in entering LMICs, and perception of manufacturers on the concept of AME label. A combination of desk research and qualitative interview was used to deduce the conclusion. Initially, a case study was conducted involving a medical equipment manufacturer based in the Netherlands, whose operations primarily targeted LMICs. The data was collected through one-to-one online semi-structured interviews with managers within this organization. The preliminary findings formed were later validated through survey and interviews conducted with a globally diverse sample size including industry and academic experts.

The results of the study indicated that the adoption of AME label has the potential to benefit manufacturers with enhanced brand value, increased visibility, improved credibility, and greater product transparency in their target markets. These factors can in turn build confidence and trust among LMIC stakeholders on AME-labeled products, opening doors for sustained business opportunities for manufacturers in these countries. By optimizing the product design towards the contextual requirements and including competitive product features, manufacturers could use the AME label as a differentiating factor in their sales. Subsequently, manufacturers could attain higher commercial value for their products and improved operating efficiency in the healthcare market of LMICs. At the same time, it is found that the introduction of the AME label could increase the complexity of the regulatory system. Manufacturers of all sizes face challenges while undergoing any regulatory process, adhering to regulatory norms, or undertaking any product label. This is unavoidable for manufacturers while supplying medical equipment across boundaries. Therefore, the inclination of manufacturers to adopt AME label depends on how effectively it streamlines the supply process, cuts administrative costs, reduces documentation work, and expedites the distribution of equipment to target countries.

Considering the novelty of the label, there are some concerns that could hinder the full-fledged adoption of the AME label by manufacturers. These concerns primarily revolve around the reliability and trustworthiness of the label. To overcome these concerns, the AME team should take into account the following aspects when implementing the label. They should carefully plan and execute steps to ensure that the label is recognized and accepted by authorized bodies like the UN, WHO, etc. It is equally important that measures need to be taken in the direction where the label is validated by all relevant stakeholders in LMICs. It is also essential to establish a clear positioning of the AME label within the regulatory system by highlighting the unique testing methods and distinctive tangible advantages it offers to the manufacturers compared to existing labels. By addressing these concerns, the widespread adoption of the AME label by medical equipment manufacturers could be achieved, leading to the availability of appropriate equipment in LMIC hospitals, and ultimately benefiting the patient groups within.

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.