Introduction

Objectives

This study is a collaboration among the World Intellectual Property Organization (WIPO), the United Nations Technology Bank for the Least Developed Countries (UN Technology Bank) and Medtronic, a multinational company that is the largest global manufacturer of MedTech. These organizations came together to leverage their respective areas of expertise in an exploration of the challenges and opportunities for the growth of MedTech innovation and access in LDCs.

The United Nations (UN) determines LDC status using three criteria: per capita income, human assets (under-five mortality, maternal mortality, adult literacy rates and gender parity for secondary school enrollment) and economic and environmental vulnerability. LDCs have an average per capita income below $1,018, a low score on the Human Assets Index and a high score on the Economic and Environmental Vulnerability Index. LDCs make up 1.1 billion of the approximately eight billion people on the planet, or about 14 percent of the total population. While the population in more developed countries is decreasing at an annual rate of -0.2 percent, the population in LDCs is growing at 2.4 percent per year. ⁽¹⁾ Population Reference Bureau (2023). World Population Data Sheet; available at: 2024 World Population Data Sheet. By 2031, more people will be living in LDCs than in more developed countries, yet they have access to significantly fewer medical treatment options. Some of the reasons for this include the lack of availability of medical products; lack of training in how to operate, maintain and repair equipment; and lack of support to innovators seeking to bring new products to market. These issues are caused by multiple factors which will be discussed throughout the report.

Understanding the MedTech sector

To understand why MedTech innovation and access to that innovation is important in LDCs, it is imperative to first understand the MedTech sector itself and the major causes of mortality and morbidity among populations in LDCs. The top causes of death in LDCs are maternal conditions (such as preeclampsia, eclampsia and postpartum hemorrhage) and neonatal conditions (such as neonatal jaundice and respiratory distress syndrome), communicable diseases and malnutrition. ⁽²⁾World Health Organization (‎2017)‎. Least developed countries: health and WHO: country presence profile; available at: https://iris.who.int/handle/10665/255802. All these conditions require MedTech to properly diagnose, treat and monitor patients.

This report defines MedTech as medical devices and diagnostics that require advanced training and infrastructure to utilize (e.g., insulin pumps, pacemakers, X-ray machines, stents). This study explores the current enablers of, and barriers to, MedTech innovation ecosystems in LDCs and identifies lessons learned and opportunities for continuing to develop MedTech innovation and access across the developing world, with a focus on LDCs.

To provide insights into the current situation of LDCs in Asia and Africa, the study uses Bangladesh and Rwanda as case studies. Both countries have developed significantly in the past few decades, with Bangladesh making so much progress that it is scheduled to graduate from LDC status in 2026. ⁽³⁾United Nations (n.d.). Bangladesh Graduation Status | LDC Portal - International Support Measures for Least Developed Countries. available at: https://www.un.org/ldcportal/content/bangladesh-graduation-status.

Definitions

This report includes imported MedTech products manufactured by multinational companies as well as local MedTech innovation. Throughout this report, the term “innovation” refers to the local development of MedTech within LDCs for domestic use. The term “access” refers to making MedTech that was developed in other countries available and affordable in the target countries.

When discussing life science innovation and access, it is important to consider the differences among the various sectors within the industry. The pharmaceutical, biotechnology and MedTech sectors contribute to improving quality of healthcare but are distinguished by the types of products developed and the infrastructure and skill set required to develop those products. This study focuses exclusively on the MedTech sector.

Demographic and epidemiological context of MedTech in LDCs

More than 75 percent of the people in LDCs live in poverty. ⁽⁴⁾Ibid. The median age in LDCs is 19.2 years, ⁽⁵⁾United Nations, Department of Economic and Social Affairs, Population Division (2022). World Population Prospects: The 2022 Revision; available at: https://population.un.org/wpp/. and the life expectancy at birth is around 65 years. ⁽⁶⁾World Bank Group (2024). Life expectancy at birth, total (years) - Least developed countries: UN classification | Data. available at: https://data.worldbank.org/indicator/SP.DYN.LE00.IN?locations=XL. In LDCs, there are 0.3 physicians per 1,000 people. In comparison, Brazil, a developing country, has 2.1 physicians per 1,000 people and the United States of America, a developed country, has 3.6 physicians per 1,000 people. ⁽⁷⁾World Bank Group (2022). Physicians (per 1,000 people); available at: https://data.worldbank.org/indicator/SH.MED.PHYS.ZS.

On average, LDCs spend about 4 percent of their GDP on healthcare, while more developed countries spend about 13 percent of their GDP on healthcare. ⁽⁸⁾World Bank Group (2025). Current Health Expenditure (% of GDP). available at: https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS. Furthermore, most of the people in LDCs live in rural areas, ⁽⁹⁾United Nations Trade and Development (2015). Least Developed Countries Report. available at: https://unctad.org/news/least-developed-countries-report-2015#:~:text=More%20than%20two%20thirds%20of,on%20the%20fight%20against%20poverty. where health systems tend to be weaker. ⁽¹⁰⁾World Health Organization (2021).Addressing Health Inequities Among People Living in Rural and Remote Areas. available at: https://iris.who.int/bitstream/handle/10665/341139/9789240024229-eng.pdf.

Currently, the top causes of death in LDCs are a mix of communicable diseases and NCDs. ⁽¹¹⁾World Health Organization (2020). The top 10 causes of death. available at: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death. However, the disease pattern in LDCs is increasingly shifting toward NCDs. NCDs were responsible for 26 percent of fatalities in LDCs in 2000; 31 percent of fatalities by 2010; and 41 percent of fatalities by 2019. ⁽¹²⁾Institute for Health Metrics and Evaluation (IHME). (2021). Global Burden of Diseases (GBD) Results. available at https://vizhub.healthdata.org/gbd-results/.

Methodology

Triple helix model of innovation

This report considers the so-called triple helix model, which describes the interplay of university-industry-government relations as a major enabler of innovation. This model argues that governments, universities and businesses interact dynamically to promote innovation. ⁽¹³⁾L. Leydesdorff and H. Etzkowitz (1996). Emergence of a triple helix of University—Industry—government relations. Science and Public Policy, available at: https://doi.org/10.1093/spp/23.5.279. For example, government defines the IP framework, which helps businesses create new products by licensing the use of technologies developed in universities.

Some important points from this model of innovation include:

• The evolving role of government throughout the innovation cycle: at some stages in the innovation cycle, the government’s role is central (e.g., while developing the initial IP and regulatory ecosystem, or providing adequate incentives to de-risk innovation), while in other stages, involvement that promotes direct interaction among academic/medical institutions and industry (e.g., when determining which inventions and discoveries should be transferred out of theoretical research in medicine/academia and commercialized) will be beneficial.

• Different countries have different strengths. Each country has a different mix of human capital with unique skills, knowledge and medical needs. This contributes to the variation seen across different national economies. By leaning into their countries’ natural strengths and encouraging specialization in these fields, governments can increase the likelihood of successful economic and industrial development. Therefore, strategies for innovation and economic growth need to be tailored to the unique needs and strengths of each LDC. For innovation to flourish, academics and businesses need to recognize what drives the other and what information is important to share with each other to encourage a successful relationship and build trust. Further, and perhaps most importantly, they need to recognize areas of common ground and the end goal. The establishment of intermediary institutions can help them bridge the divide and translate scientific advances into viable products. A functional and well-coordinated institutional setup is essential for translating the theoretical framework of the triple helix, government, academia and industry collaboration, into tangible innovation outcomes. In LDCs, where innovation ecosystems are typically nascent, the absence of strong intermediary institutions often hinders the alignment of actors.

To understand the roles of governments, businesses and academic institutions in promoting MedTech innovation and access, it is imperative to keep these points in mind throughout the rest of this publication.

This study began with a literature review that looked into enablers of, and barriers to, MedTech innovation and access. The literature was collected from a variety of sources including but not limited to academic journals, patent landscape reports and government reports. It encompassed topics that included innovation ecosystem frameworks, the role of IP in MedTech development, and information on the status of IP, regulatory systems, infrastructure, workforce and manufacturing capacity in LDCs in general. It also examined national health, industrial, IP, innovation and regulatory policies.

Translating lessons learned from case studies

To provide a more comprehensive and practical understanding of the enablers of and barriers to MedTech innovation and access, it was essential to select specific countries as case studies. The case study countries were chosen based on several criteria, including their location in regions with a high concentration of LDCs so that lessons learned could be more easily transferrable and applicable to neighboring LDCs. Most LDCs are in Africa (32 of 44) and Asia (8 of 44). ⁽¹⁴⁾UN Trade and Development. (2024). UN List of Least Developed Countries. Available at: https://unctad.org/topic/least-developed-countries/list. Selected countries also needed to commit to developing their healthcare innovation and access ecosystems and to already have some existing MedTech industry present. Based on these criteria, we selected Bangladesh and Rwanda.

Rwanda has emerged as one of Africa’s most innovative economies. It has prioritized its population’s healthcare needs over the last few decades and has been a leading country in Sub-Saharan Africa in tracking NCDs and developing programs to tackle the challenges they pose. Rwanda hosts the headquarters of the African Medicines Agency, a specialized agency of the African Union, ⁽¹⁵⁾African Medicines Agency (AMA). (n.d.). available at: https://amrh.nepad.org/african-medicines-agency-ama; AUDA-NEPAD African Union Development Agency. (2022). List of Countries that have ratified AMA treaty; available at: https://www.nepad.org/content/list-of-countries-have-ratified-ama-treaty. which acts as the leading medical regulatory body for the African continent. Home to a growing MedTech innovation ecosystem, which contains initiatives like the East Africa Biodesign program, ⁽¹⁶⁾Stanford Mussallem Center for Biodesign. (n.d.). East Africa Biodesign; available at: https://biodesign.stanford.edu/programs/global-initiatives/east-africa-biodesign.html. it is paving the way for new medical technologies to be developed and made available.

Bangladesh was selected due to its status as a graduating LDC in 2026 ⁽¹⁷⁾United Nations: LDC Portal - International Support Measures for Least Developed Countries. Bangladesh Graduation Status; available at: https://www.un.org/ldcportal/content/bangladesh-graduation-status?&&&&node_field_publication_date_value%5Bmax%5D&node_field_publication_date_value%5Bmin%5D&node_field_publication_date_value%5Bvalue%5D&node_field_uw_document_is_archived=All&&search_api_views_fulltext=Bangladesh&page=1. and the progress it has made over the past few decades in advancing healthcare innovation and improving healthcare access for its population. For example, the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) has the largest diabetic outpatient turnover (i.e., the rate at which diabetic patients are seen and discharged from a facility) in the world in a single physical space and is a leading research center worldwide. ⁽¹⁸⁾Sunman- Birdem Pharma (2024). About Us; available at: https://www.sunmanbirdem.com/about-us/#:~:text=BIRDEM%20(Bangladesh%20Institute%20of%20Research.

WIPO, the UN Technology Bank and Medtronic contributed to the study in the following ways:

• WIPO: Program managers – coordinated activities across the three organizations and led research and report writing activities.

• UN Technology Bank for the Least Developed Countries: Public sector specialists – supported local research activities in Rwanda and Bangladesh and provided resources to assess the technology needs of LDCs.

• Medtronic: Private sector specialists (largest MedTech company in the world ⁽¹⁹⁾H. Burke. Who are the top 10 medical device companies in the world in 2024? Proclinical; available at: https://www.proclinical.com/blogs/2024-10/top-10-medical-device-companies-in-the-world-in-2024.) – connected investigators to subject matter experts who support or come from the private sector and share insights.

PatentSight, the African Regional Intellectual Property Organization (ARIPO) patent database, and the Bangladesh and Rwanda national IP databases were consulted. The WIPO country profiles for Bangladesh and Rwanda were also referenced, as were the UN Technology Bank’s Technology Needs Assessments for Bangladesh and Rwanda.

Once the literature review and background research relevant to the national IP systems were completed, semi-structured, open-ended interviews were conducted with subject-matter experts to complement the secondary data. The interviews were conducted to collect direct feedback on the current state and aspirations of MedTech stakeholders in each country and internationally. The UN Technology Bank supervised local MedTech consultants in Bangladesh and Rwanda to conduct in-country interviews. These interviews captured the constraints and aspirations of relevant, local MedTech stakeholders in each country, including health ministries, science and technology ministries, IP offices, local industry, innovators, investors, donors, NGOs and academic institutions.

The study partners collaborated to generate a questionnaire to drive uniformity across all open-ended interviews in Bangladesh, Rwanda and internationally. The interviewers used this questionnaire to structure their conversations with the interviewees, giving them the opportunity to dive deeply into specific topics where relevant. This questionnaire, which can be found in Annex 1, gathered holistic information about the innovation ecosystem and explored topics related to MedTech IP, regulatory, financing and infrastructure/capacity. The questionnaire was used to interview a broad range of stakeholders including but not limited to executives of international corporations, government ministry representatives, multilateral development banks, regulatory experts, IP experts, local innovators, professional societies, etc. A total of 68 interviews were conducted for this project over six months. More information on the types of stakeholders interviewed can be found in Annex 2.