Incentives for Manufacturers in Certifying Medical Equipment for Low- and Middle-Income Countries

Abstract

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.