Main challenges and enablers in the MedTech sector in LDCs

The MedTech sector in LDCs is affected by several challenges and enablers. The challenges make it more difficult for the MedTech sector to flourish and the enablers increase the likelihood of the sector succeeding. These challenges and enablers come from both the public and private sectors. Governments can pursue policies that have beneficial or detrimental effects on MedTech developments. They can encourage research and development (R&D) by providing sources of funding for entrepreneurs or by pursuing the triple helix model of innovation to promote development in specific fields that are best suited to their local contexts.

Similarly, academic institutions and private companies can encourage development by engaging with public sector institutions to foster improved capacity and more efficient performance. The study has divided the main challenges and enablers into four categories: IP, regulatory systems, financial incentives and capacity.

Intellectual property’s role

IP plays an important role in stimulating innovation to develop new medical products to address global health challenges. IP contributes not only to fostering innovation but also to the manufacture of MedTech products by providing incentives to attract investment; offset the risks of failures; and support the transfer of technologies and know-how. Appropriate IP protection fosters innovation, including domestic innovation, and technological development by incentivizing entrepreneurs and businesses, whereas its absence can hinder progress. ⁽¹⁾Commonwealth Secretariat and the UN Trade and Development. (2024). Harnessing Intellectual Property Rights for Innovation, Development and Economic Transformation in Least Developed Countries; available at: https://unctad.org/system/files/official-document/comsec2024d1_en.pdf.

MedTech products can be protected by various categories of IP, including patents, utility models, trademarks, trade secrets, copyright and industrial designs. ⁽²⁾T. Aplin and J. Liddicoat. Discussion Paper on The Interplay Between Patents and Trade Secrets in Medical Technologies. SSRN Electronic Journal’ available at: https://doi.org/10.2139/ssrn.4606923.

Patents for innovation

A patent is an exclusive right granted for an invention that introduces a new way of doing something or offers a new technical solution to a problem. ⁽³⁾World Intellectual Property Organization. (n.d.). Patents: What is a Patent?; available at: https://www.wipo.int/en/web/patents. To obtain a patent, an inventor, among other conditions, must clearly disclose the technical details of the invention in the patent application, enabling a person skilled in the relevant technical field to replicate it. ⁽⁴⁾Ibid. The details of the invention are then published and made available to the public at large, thereby contributing to knowledge dissemination through technology disclosure and accelerating progress by encouraging innovative and novel product development. The patent owner has the right to stop others from using the patented invention for commercial purposes without the patent owner’s authorization. ⁽⁵⁾Ibid. By providing such exclusive rights for a limited time (in most cases 20 years), patents enable inventors to recoup their investments while contributing to the broader scientific community’s knowledge. ⁽⁶⁾World Intellectual Property Organization (n.d.). Frequently Asked Questions: Patents. available at: https://www.wipo.int/web/patents/faq_patents. Information contained in patent documents can be very useful to researchers, entrepreneurs and many others.

For example, it allows freedom to operate analyses (i.e., ensuring that the commercial production, marketing and use of a new product or process does not infringe the patent rights of others). These analyses enhance the innovation ecosystem by guiding innovators in identifying opportunities and eschewing infringement, thereby better directing research and development efforts. ⁽⁷⁾Commonwealth and UNCTAD; op. cit.

Further, innovators use patent information to build on existing patents, evaluate the patentability of their own innovations, identify licensing and partnership opportunities, and stay informed about industry developments. ⁽⁸⁾World Intellectual Property Organization (n.d.). Patent and Technology Information; available at: https://webcms.wipo.int/en/web/patents/patent-information.

Patents vs. trade secrets

In contrast, trade secrets protect confidential information. Trade secrets can have significant value and may be licensed, while not being subject to public disclosure. ⁽⁹⁾World Intellectual Property Organization (n.d.). Trade Secrets: What is a Trade Secret?; available at: https://www.wipo.int/tradesecrets/en/. Trade secrets are safeguarded through various measures, such as non-disclosure agreements with employees, business partners, consultants and agents, as well as security infrastructures, offering a cost-effective way to prevent misuse of proprietary information. ⁽¹⁰⁾Ibid; United Kingdom Intellectual Property Office (2021). The economic and innovation impacts of trade secrets; available at: https://www.gov.uk/government/publications/economic-and-innovation-impacts-of-trade-secrets/the-economic-and-innovation-impacts-of-trade-secrets. Trade secrets can be transferred through licenses. ⁽¹¹⁾Ibid. Trade secrets can either supplement patents or serve as an alternative, providing flexibility in the way MedTech innovations are protected. ⁽¹²⁾Ibid.

Trade secrets, however, do not stop other innovators from re-inventing or reverse engineering a technology, making such protection relatively limited. ⁽¹³⁾See Aplin and Liddicoat, op. cit. When an invention is likely to qualify for patent protection, the decision about whether to use a patent or to keep information as a trade secret should be made on a case-by-case basis. Patents are typically preferred for protecting product innovations, while trade secrets are often better suited for safeguarding process innovations. ⁽¹⁴⁾See United Kingdom Intellectual Property Office, op. cit. Moreover, trade secret protection should be considered in cases where the subject matter is not patentable, or where secrecy can be maintained for a considerable period of time (longer than the maximum term of patents). ⁽¹⁵⁾See WIPO, op. cit.

Trade secrets protection is generally useful to protect an innovation until the innovator has decided on a clear patent strategy. ⁽¹⁶⁾See WIPO, op. cit.

Utility models

Similar to patents, utility models protect minor improvements to existing products that may not meet the requirements for patentability but can still play a significant role in local innovation. ⁽¹⁷⁾World Intellectual Property Organization (n.d.). Utility models; available at: https://www.wipo.int/web/patents/topics/utility_models. Utility models protect the exclusive right to commercial use of the protected invention. ⁽¹⁸⁾Ibid. Utility models are recognized and protected in the IP laws of relatively few countries. ⁽¹⁹⁾See Commonwealth and UNCTAD, op. cit. LDCs such as the Lao People’s Democratic Republic, Mozambique, Rwanda, Uganda and the United Republic of Tanzania provide protection for utility models. ⁽²⁰⁾See Commonwealth and UNCTAD, op. cit. Utility models can enable LDCs to convert minor inventions to wealth and social benefits. ⁽²¹⁾See Commonwealth and UNCTAD, op. cit.

Trademarks, copyright and industrial designs

Trademarks and copyright can be used to help distinguish MedTech products, inform consumers and fight piracy, counterfeiting and unfair competition in the MedTech industry. ⁽²²⁾WHO-WIPO-WTO (2012). Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade; available at: https://www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf. A trademark is a sign that distinguishes the goods or services of one enterprise from those of other enterprises. ⁽²³⁾ World Intellectual Property Organization (n.d.).Trademarks: What is a trademark?; available at: https://www.wipo.int/trademarks/en/ A trademark can be a word or a combination of words, letters, numerals, drawings, symbols and three-dimensional features, such as the shape and packaging of goods. ⁽²⁴⁾Ibid. Copyright covers rights of creators over their literary and artistic works and, in the case of MedTech products, it protects the contents on their packaging, such as the brand name, logo, color scheme, product information and other elements comprising the overall look and feel. ⁽²⁵⁾World Intellectual Property Organization (n.d.).Copyright: What is copyright?; available at: https://www.wipo.int/copyright/en/. In some cases, they may protect the unique aesthetic features of the product inside the packaging that signify its origin, such as its shape and patterns.

Industrial designs may consist of three-dimensional features, such as the shape of an article, or two-dimensional features, such as patterns, lines or color and the ornamental aspects of a MedTech product that enhance patient experience. These could serve to build brand value and consumer recall, thereby contributing to the commercial success of a MedTech product. ⁽²⁶⁾World Intellectual Property Organization (n.d.). Industrial Designs: What is an Industrial Design?; available at: https://www.wipo.int/designs/en/.

International IP law and special treatment for LDCs

WIPO administers 28 treaties that cover different areas of IP, setting basic standards, global protection systems and classification rules for various products, services and other subject matters. ⁽²⁷⁾World Intellectual Property Organization (n.d.). WIPO-Administered Treaties; available at: https://www.wipo.int/treaties/en/. For example, the Paris Convention ⁽²⁸⁾Paris Convention for the Protection of Industrial Property (1883). applies in the widest sense to industrial property, including patents, trademarks and industrial designs, and lays down substantive provisions governing their registration. In contrast, the Berne Convention ⁽²⁹⁾Berne Convention for the Protection of Literary and Artistic Works (1886). sets out minimum standards for copyright protection for literary and artistic works. Another key treaty is the Patent Cooperation Treaty, which allows inventors to seek patent protection in almost 160 countries with a single international application. ⁽³⁰⁾Patent Cooperation Treaty (PCT) (1970).

In addition to the treaties administered by WIPO, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement of the World Trade Organization (WTO) is a comprehensive multilateral treaty covering all key areas of IP, including patent, undisclosed information, trademark, geographical indication, industrial design and copyright. It sets out minimum international standards for the protection of various forms of IP rights; establishes general principles on domestic enforcement mechanisms; and addresses disputes between members.

Both the TRIPS Agreement and the Paris Convention also provide certain mechanisms that countries use to meet their public health objectives.

LDCs receive special treatment under the TRIPS Agreement due to their unique needs, financial constraints and the necessity for flexibility to establish a strong technological foundation. ⁽³¹⁾United Nations. (2022). A Guide to Least Developed Country Graduation; available at: https://www.un.org/ohrlls/sites/www.un.org.ohrlls/files/graduation_booklet_2022_en.pdf In this respect, LDCs are exempt from applying the provisions of the agreement until 1 July, 2034, or before the date of their graduation from LDC status, whichever is earlier, according to the decision of the WTO. ⁽³²⁾World Trade Organization. (2021). WTO members agree to extend TRIPS transition period for LDCs until 1 July 2034; available at: https://www.wto.org/english/news_e/news21_e/trip_30jun21_e.htm; World Trade Organization. (1994). Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299; available at: https://www.wto.org/english/docs_e/legal_e/27-trips.pdf; LDCs are however not exempt from applying Articles 3, 4 and 5 of TRIPS. However, the majority of LDCs have enacted laws and put in place mechanisms to provide protection for these IP rights through national or regional offices.

In Africa, several LDCs are leveraging regional cooperation to create capacity for processing IP filings and administering the rights registered or granted through two regional IP offices: the African Intellectual Property Organization (OAPI) and ARIPO.

OAPI serves as the IP office for industrial property for 17 member states in Africa and provides unitary protection for the territory of its entire membership. ⁽³³⁾OAPI, African Intellectual Property Organization; available at: https://www.oapi.int/wp-content/uploads/2023/11/anglais.pdf; Bangui Agreement Relating to the Creation of an African Intellectual Property Organization. (1977). OAPI was established under the Bangui Agreement adopted in 1977, which aims to enhance development in member states by promoting technological innovation, technology transfer and creativity and by providing uniform and effective protection and education in IP rights. ⁽³⁴⁾Ibid. LDCs that are member states of OAPI are Benin, Burkina Faso, Central African Republic, Chad, Comoros, Guinea, Guinea-Bissau, Mali, Mauritania, Niger, Senegal and Togo. ⁽³⁵⁾Ibid. See also World Intellectual Property Organization. African Intellectual Property Organization (OAPI): Member States; available at: https://www.wipo.int/wipolex/en/members/profile/OAPI

ARIPO was established under the Lusaka Agreement adopted in 1976 as a designation system to pool the resources of its member states in IP matters and to thereby prevent duplication of financial and human resources. The Lusaka Agreement’s preamble highlights the benefits of effective and continuous information exchange, as well as the harmonization and coordination of laws and activities in IP matters among member states. LDCs that have signed on to the ARIPO system are Gambia, Lesotho, Liberia, Malawi, Mozambique, Rwanda, Sierra Leone, Somalia, Sudan, United Republic of Tanzania, Uganda and Zambia. ⁽³⁶⁾World Intellectual Property Organization. IP Treaties Collection: Lusaka Agreement (ARIPO) (Total Members: 22); available at: https://www.wipo.int/wipolex/en/treaties/parties/202.

While there is no regional IP office in Asia, the Association of Southeast Asian Nations (ASEAN) is working to harmonize standards to guide the practices of IP offices in member states. Additionally, ASEAN provides several services and programs for businesses, such as IP training platforms for small and medium-sized enterprises (SMEs), databases of case laws and case studies, IP action plans and IP statistics. It also provides a patent work-sharing program among IP offices of nine member states, including two LDCs, Cambodia and Lao People’s Democratic Republic. The goal is to share search and examination results among the participating offices, enabling applicants to obtain corresponding patents more quickly and efficiently. ⁽³⁷⁾ASEAN Intellectual Property Portal. What is ASPEC?; available at: https://www.aseanip.org/services/asean-patent-examination-co-operation-(aspec)/what-is-aspec.

LDCs often overlooked

During the interviews conducted for this study with IP experts from MedTech companies, national IP offices and law firms, it became evident that global MedTech companies often overlook LDCs and do not prefer them as IP filing destinations. The stakeholder interviews in the study suggested that they perceive LDCs as having weak IP administration and enforcement capacities, which deters companies from filing there. They acknowledged the importance of having a strong IP protection and enforcement system in place to encourage foreign investment. Some experts highlighted a lack of trust in IP systems in LDCs, mentioning that both local innovators and global MedTech companies often prefer to file for their IP in more developed markets. This preference is driven by the higher sense of certainty that their applications will be reviewed promptly and that their IP rights can be effectively enforced by customs or judicial authorities in those countries. In LDCs, applications filed for industrial property account for only a fraction of those filed globally. ⁽³⁸⁾Commonwealth and UNCTAD, op. cit. Specifically, applications for patents, utility models and industrial designs in LDCs represent just 0.04 percent, 0.01 percent and 0.25 percent of the global total, respectively. Even trademarks, which are the most-used form of IP in LDCs and globally, filings in LDCs account for only 1.52 percent of global filings. ⁽³⁹⁾Commonwealth and UNCTAD, op. cit. Reasons behind lower IP filings in LDCs include poor awareness, limited use of information and communication technology, high filing fees, inadequate legal frameworks, lack of specialized skills and insufficient enforcement mechanisms. ⁽⁴⁰⁾Commonwealth and UNCTAD, op. cit.

However, the number of applications has generally increased in recent years. ⁽⁴¹⁾Commonwealth and UNCTAD, op. cit. Particularly for patents, several LDCs show higher filings in the MedTech sector as compared to other sectors, indicating a growing presence of MedTech innovations. WIPO’s country-specific IP statistics for 2023 show that MedTech was one of the top technical fields for patent filings through the Patent Cooperation Treaty system in the Democratic Republic of the Congo, Ethiopia, Nepal, Niger and United Republic of Tanzania. ⁽⁴²⁾World Intellectual Property Organization. (2023). WIPO Intellectual Property Statistical Country Profile: Democratic Republic of Congo; available at: https://www.wipo.int/edocs/statistics-country-profile/en/cd.pdf; World Intellectual Property Organization. (2023). WIPO Intellectual Property Statistical Country Profile: Ethiopia; available at: https://www.wipo.int/edocs/statistics-country-profile/en/et.pdf; World Intellectual Property Organization. (2023). WIPO Intellectual Property Statistical Country Profile: Nepal; available at: https://www.wipo.int/edocs/statistics-country-profile/en/np.pdf; World Intellectual Property Organization. (2023). WIPO Intellectual Property Statistical Country Profile: Niger; available at:https://www.wipo.int/edocs/statistics-country-profile/en/ne.pdf; World Intellectual Property Organization. (2023). WIPO Intellectual Property Statistical Country Profile: United Republic of Tanzania; available at: https://www.wipo.int/edocs/statistics-country-profile/en/tz.pdf.

Effectively navigating the path to graduation from LDC status would be facilitated by concerted efforts from countries to strengthen their innovation capacities and IP ecosystems. This would require a context-specific approach aligned with their development goals. ⁽⁴³⁾T. Pengelly. (2024). International Trade Working Paper: Graduating with Momentum: Intellectual Property Issues, Challenges and Opportunities for Least Developed Countries. The Commonwealth Secretariat; available at: https://www.thecommonwealth-ilibrary.org/index.php/comsec/catalog/download/1128/1226/9803?inline=1. The following sections of the report on the case studies of Bangladesh and Rwanda will demonstrate this.

Technology transfer

WHO’s Local Production and Technology Transfer to Increase Access to Medical Devices Report defines technology transfer as “the transfer of technical information, tacit know-how, performance skills, technical material or equipment, jointly or as individual elements, with the intent of enabling the technological or manufacturing capacity of the recipients.” Particularly for medical devices, technology transfer entails sharing resources and know-how to manufacture the medical devices needed to address public health needs. ⁽⁴⁴⁾World Health Organization. (2012). Local Production and Technology Transfer to Increase Access to Medical Devices – Addressing the barriers and challenges in LMIC; available at: https://www.who.int/publications/i/item/9789241504546.

Technology transfer in LDCs, particularly in the MedTech sector, is essential but faces numerous challenges, as many of these countries may not have the optimal technical expertise, absorptive capacity, infrastructure and resources available to fully benefit from technology transfer processes. While technology transfer occurs through various channels, such as foreign direct investment, joint ventures, licensing agreements, public-private partnerships and research collaborations, its presence in LDCs’ MedTech sector is limited.

In LDCs, examples of successful technology transfer are more prevalent in other industries. For example, the garment sector benefits from joint ventures with foreign firms; the pharmaceutical sector frequently engages in licensing agreements to produce generic drugs; and academic exchanges facilitate agricultural research advancements through collaborations between universities and international institutions.

The challenges hindering technology transfer in the MedTech sector include regulatory and policy barriers, such as inconsistent enforcement of IP rights. This inconsistency can deter foreign companies from transferring technology, as they may perceive risks associated with inadequate IP protection. Additionally, lack of infrastructure, insufficient local expertise and limited financial resources can further impede the development and implementation of effective technology transfer mechanisms. Despite these challenges, technology transfer in LDCs has recently started to gain more traction in the life sciences sector. ⁽⁴⁵⁾U. Murad and M. Ahsan. (2019). Critical success factors of technology transfer: an investigation into the health sector of Bangladesh. University of Technology; available at: https://www.researchgate.net/publication/345701215_Critical_success_factors_of_technology_transfer_an_investigation_into_the_health_sector_of_Bangladesh. A WHO literature review study identified health information technology, medical products and health service delivery as key areas in which LDCs could greatly benefit from technology transfer. ⁽⁴⁶⁾S.B. Syed, et al.. (2012). Developed-developing country partnerships: Benefits to developed countries?. Globalization and Health; available at: https://globalizationandhealth.biomedcentral.com/articles/10.1186/1744-8603-8-17#citeas. As an enabler, technology transfer can facilitate the increase of local manufacturing and supply capacity by reducing dependency on international supply chains and mitigating the risk of supply chain disruptions. This can delay the availability of critical MedTech products, especially during emergencies like pandemics or natural disasters. This issue was exposed during the COVID-19 pandemic, when the absence of local manufacturing capability and capacity hindered the ability of some countries to rapidly deploy necessary medical countermeasures.

Technology transfer for MedTech during COVID-19

During the pandemic, some innovator companies entered into voluntary licensing agreements with local generic manufacturers to produce certain MedTech products. Others waived their IP rights for the duration of the pandemic to facilitate early access to their products. For example, a leading global MedTech company has worked to improve local capacity via technology transfer and, in doing so, gained firsthand experience of technology transfer enablers and barriers in LDCs as a result (see Box 1).

The handover of know-how and skills that inherently comes with technology transfer can aid in bridging the manufacturing capacity gap that hinders local production of medical technologies in many LDCs.

Factors contributing to successful technology transfer

Broadly speaking, evidence-based studies on successful technology transfer in the MedTech sector are limited; this is even more evident when looking at examples in LDCs. ⁽⁴⁸⁾A. Vexler and J. Yu. (2018). Empirical Likelihood Methods in Biomedicine and Health. Chapman and Hall/CRC. However, a recent study on the transfer of technology related to the health sector in developing countries and LDCs found that factors like top management support, political support for adopting standardized project management practices, financial support and availability of technology infrastructure are critical to the success of a technology transfer process. ⁽⁴⁹⁾U. Murad, et al. (2021). Critical Success Factors of Technology Transfer: An Investigation into the Health Sector of Bangladesh Using ISM-DEMATEL Approach. Technology Management and Leadership in Digital Transformation” PICMET ‘21 Conference; DOI: 10.23919/PICMET59654.2023.10216839.

These findings are supported by the ventilator case study on technology transfer during COVID-19, which illustrates how openly sharing technical knowledge, when combined with strong organizational and infrastructure support, can effectively facilitate such a transfer.

For Bangladesh, the study highlighted 15 critical success factors for technology transfer (see Box 2). The data highlight that risk management, communication and IT infrastructure are most frequently cited. Capacity-related factors – such as employee training, skilled human resources and the receiver’s absorptive capacity – also emerge as critical enablers of successful technology transfer in the health sector.

The complexity of implementing a successful technology transfer in the MedTech sector can be inferred from the factors mentioned above. Moreover, during the interviews conducted with stakeholders, many indicated having encountered challenges in addition to those mentioned above. They included lack of infrastructure for advanced manufacturing, supply chain complexities, shortage of skilled workers, lack of regulatory frameworks, inadequate IP protection, and ensuring the technology was maintained.

To tackle the complex challenges of technology transfer, coordinated efforts and strategic alliances are key. Collaborative partnerships in the life science sector harness the collective strengths of multiple stakeholders and have proven useful to efficiently utilize resources and mitigate risks.

Patent pooling for technology transfer

Another way to facilitate technology transfer in LDCs is patent pooling – an agreement among two or more patent owners to license one or more of their patents to one another or to third parties. This mechanism can substantially facilitate technology transfer in LDCs by leveraging shared resources, reducing costs and enhancing access to technologies.

The Medicines Patent Pool (MPP) was the first patent pool organization with a specific mandate to negotiate licenses driven by public health with innovator pharmaceutical companies and then sublicense to generic producers, with the aim of increasing access to life-saving therapies in developing countries and LDCs. Since its establishment in 2010 ⁽⁵⁰⁾Medicines Patent Pool. Who We Are. Available at: Who We Are - About MPP., most of the licenses negotiated by MPP have targeted medicines. Nonetheless, in early 2024, MPP signed a license agreement with an in-vitro diagnostics company. In that instance, the license agreement was signed with SD Biosensor, Inc., to provide the know-how to manufacture rapid diagnostic testing technology (see Box 3).

Regulatory systems for MedTech

MedTech products are fundamental in the prevention, diagnosis and treatment of various medical conditions and it is essential that these devices are safe and quality assured. To ensure these devices are effective, safe and used as instructed, governments entrust regulatory authorities to provide oversight on access to these medical products. ⁽⁵³⁾ World Health Organization (n.d.).Regulation and Prequalification, available at: https://www.who.int/teams/regulation-prequalification/regulation-and-safety/rss/programme.

Some of the main functions for which regulatory authorities are responsible include licensing of the manufacture, import, export and distribution of medical products; issuance of market authorization; assessment of the safety and efficacy of medical devices; inspection of manufacturers and distributors; and control and monitoring of the quality of medical devices. ⁽⁵⁴⁾L. Rägo and B. Santoso. (2008). Drug Regulation: History, Present and Future. Drug Benefits and Risks: International Textbook Of Clinical Pharmacology. IOS Press.

LDCs often lag behind developed countries when it comes to robust regulatory systems for medical devices. In more developed settings, like North America and the European Union, countries have strict and specific regulations that govern medical devices, providing patients with assurance of safe and effective devices. ⁽⁵⁵⁾B. Chettri and R. Ravi. (2024). A comparative study of medical device regulation between countries based on their economies, Expert Review of Medical Devices; available at: https://pubmed.ncbi.nlm.nih.gov/38832832/. In LDCs, this level of assurance is still evolving. Weak regulatory systems may go hand-in-hand with fragmented regulatory functions in a country as well as lack of medical device-specific regulations and explicit regulatory guidance for new and emerging medical technologies, like healthcare solutions driven by artificial intelligence (AI).

To be able to implement the above-mentioned functions, regulatory authorities must have a legal mandate to function. In practice, this mandate would be rooted in a legal or regulatory framework that allows them to control the efficacy and safety of medical devices being imported into or manufactured in their country. In Africa, the regulation of medical devices differs from country to country. In some countries, a separate regulatory body regulates medical devices; in others, it is the ministry of health or ministry of trade.

Simplify by streamlining regulatory process

A streamlined regulatory process across African countries could simplify the process of introducing medical technologies into the market. However, while the African Union has created a regulatory framework model for medical devices, it has not been widely implemented. ⁽⁵⁶⁾Chettri and Ravi. (2024); op. cit.

Only a handful of countries in Africa have established regulatory systems. ⁽⁵⁷⁾S. Hubner, et.al. (2021). The evolving landscape of medical device regulation in East, Central and Southern Africa. Global Health: Science and Practice; available from: The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa - PubMed. A 2017 report by WHO indicated that 40 percent of countries in the African region had no regulations for medical devices, 32 percent had some regulations and, for the remaining 28 percent, there were no available data. ⁽⁵⁸⁾World Health Organization. (2017). WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices. WHO Medical Device Technical Series; available at: https://www.who.int/publications/i/item/9789241512350. Many countries lack the financial resources and technical expertise (which includes trained reviewers with the right technical backgrounds) to strengthen their regulatory systems.

To better understand the state of medical device regulations in Africa, experts in 14 countries from East, Central and Southern Africa surveyed the medical device regulation landscape and found that half had no formal regulatory process for evaluating medical devices. ⁽⁵⁹⁾See Hubner, et al.; op. cit. The experts also found that two factors were closely linked to the level of medical device regulation: the country’s GDP and how long the country had been independent from any colonial power.

A comparative study of medical device regulation among countries based on their economies found that developed countries have strict regulatory frameworks for medical devices. ⁽⁶⁰⁾Chhetri and Ravi; op. cit. On the other hand, in Africa, regulations around medical devices are complex and lack clarity among regulatory organizations in the region. However, despite this, the demand for medical devices is on the rise on the continent, highlighting the need for efficient and harmonized medical device regulation. ⁽⁶¹⁾C. De Maria, et al.. (2018). Safe innovation: On medical device legislation in Europe and Africa. Health Policy and Technology; available at: https://www.sciencedirect.com/science/article/pii/S2211883718300303. Cognizant of the importance of regulatory control, leaders of several African countries are developing regulations by adopting or harmonizing provisions.

MedTech regulatory guidance needed

Another challenge many LDCs encounter in their regulations is the lack of specific regulatory guidance for new and emerging medical technologies, including those that incorporate the use of AI in medical devices. This gap in the regulatory framework can create significant uncertainty for companies trying to bring innovative products to market, as they may struggle to understand the requirements and navigate the approval process effectively. To address this, both the United States and the European Union have released action plans on the use of AI in medical devices and are continuously working on aligning their regulations to ensure safe use of AI in medical devices.

Effective regulatory systems are essential to strengthening health systems and improving public health outcomes. An inefficient regulatory systems can serve as a barrier to MedTech access ⁽⁶²⁾World Health Organization. (2014). Resolutions and Decisions. Sixty-Seventh World Health Assembly. Geneva; available at: apps.who.int/gb/ebwha/pdf_files/WHA67-REC1/A67_2014_REC1-en.pdf. by limiting a country’s ability to regulate products and disincentivizing local innovation and manufacturing and foreign investment. Globally, more than 70 percent of countries have weak national regulatory systems. ⁽⁶³⁾S. Azatyan. (2023).Technical Briefing Seminar (TBS) on Medicines and Health Products, World Health Organization; presentation available at: cdn.who.int/media/docs/default-source/health-products-policy-and-standards/7_who-guidelines-on-good-reliance-practices–applicability-and-prospects-for-implementation_samuel-azatyan.pdf?sfvrsn=2e31f8ca_1.

Many of these systems are designed primarily with a pharmaceutical lens, with regulators trying to fit MedTech into pharmaceutical-compliant regulatory systems. The inability to fully differentiate between MedTech and pharma can negatively affect public health insofar as access to health technologies is concerned. Without regulatory frameworks that are appropriate for the MedTech space, it can take much longer to move innovative devices from concept to market.

Policymakers and regulators may not understand the fundamental differences among different types of health technologies (vaccines, drugs, medical devices and diagnostics). In some LDCs, medical devices and drugs fall under the same regulations, which can lead to operational challenges and delays in approvals. That is because each type of health technology is unique and may require a different regulatory pathway.

Regulatory reliance

One way to continue to encourage MedTech innovation and access while the national regulatory system is developing is to pursue regulatory reliance. Regulatory reliance occurs when one country’s national regulatory authority (NRA) considers the assessment performed by another country’s NRA in reaching its own decision. ⁽⁶⁴⁾World Health Organization. (2021). WHO Publishes new guidance to promote Strong, Efficient and Sustainable Regulatory Systems; available at: https://www.who.int/news/item/29-04-2021-who-publishes-new-guidance-to-promote-strong-efficient-and-sustainable-regulatory-systems. This approach helps health authorities expedite the approval process by leveraging assessments of trusted regulatory bodies, thereby avoiding the need to duplicate resource-intensive evaluation. Through this practice, MedTech products can reach the market faster, enhancing timely access to critical innovations.

There are several ways to practice regulatory reliance, including work-sharing, abridged pathways and unilateral or mutual recognition. Work-sharing happens when NRAs of two or more jurisdictions share the workload to accomplish regulatory approvals. In contrast, abridged pathways take place through procedures where regulatory decisions are based on the application of reliance, and lastly, reliance through recognition often entails the acceptance of a regulatory decision that has been issued by another NRA or institution.

To strengthen countries’ regulatory cooperation and convergence and to speed access to medical technologies, WHO has issued the good regulatory practices (GRP) and the good reliance practices (GRelP) documents. Published in 2021, these documents aim to support countries in their efforts to improve regulation and oversight of medical products. ⁽⁶⁵⁾World Health Organization. (2021). TRS 1033 - Annex 11: Good regulatory practices in the regulation of medical products; Annex 11, WHO Technical Report Series; available at: https://www.who.int/publications/m/item/annex-11-trs-1033; World Health Organization. (2021). TRS 1033 - Annex 10: Good reliance practices in the regulation of medical products: high level principles and considerations; available at: https://www.who.int/publications/m/item/annex-10-trs-1033. Additionally, WHO’s Global Model Regulatory Framework provides comprehensive guidelines for countries to develop and enhance their regulatory systems, promoting convergence toward international best practices. The framework offers a stepwise approach to regulating medical devices, acknowledging countries’ varying levels of development and prioritizing regulatory responsibilities accordingly. ⁽⁶⁶⁾See WHO GMRF; op. cit.

Harmonization creates uniform standards

Another way to encourage MedTech innovation and access is through regulatory harmonization, defined as “a process whereby the technical guidelines of participating authorities in several countries are made uniform.” Harmonization can simplify the regulatory process for companies seeking approval across multiple countries by standardizing requirements, thereby reducing the complexity and duration of the approval process. Discrepancies in dossier requirements across countries can complicate and prolong the submission process, creating significant challenges for companies trying to meet diverse regulatory demands.

It is important to note that, while harmonization facilitates regulatory reliance by creating uniform standards across jurisdictions, the absence of harmonization does not preclude the practice of reliance. Regulatory authorities can still rely on the assessments of trusted partners, even if complete harmonization is not achieved. In March 2024, the 25th Management Committee Meeting of the International Medical Device Regulators Forum highlighted reliance as a cornerstone of collaboration and harmonization in regulatory frameworks for medical devices. ⁽⁶⁷⁾Pharmacy and Poisons Board, Republic of Kenya. (2024). Kenya’s PPB and US FDA Form Strategic Alliance to Advance Regulatory Standards; available at: https://web.pharmacyboardkenya.org/Pharmacy-and-Poiso-6/. Immediately after this session, Kenya’s Pharmacy and Poisons Board formalized a strategic partnership with the FDA and committed to pursue reliance and harmonization. ⁽⁶⁸⁾Ibid.

Regional and international initiatives have facilitated the use of regulatory reliance and good regulatory practices for LDCs. WHO’s Prequalification of Medical Products, for example, assesses the quality, efficacy and safety of medical products and provides many LDCs with a trusted reference. ⁽⁶⁹⁾World Health Organization. (2013). Prequalification of medicines by WHO; available at: https://www.who.int/news-room/fact-sheets/detail/prequalification-of-medicines-by-who. In 2010, WHO launched the prequalification of IVD, which provides regulatory support for NRAs in LDCs where medical device regulation is still evolving.

Some interviewees reported potential areas for improvement to the prequalification process, particularly regarding its duration, which can extend to several years. Suggested improvements included adopting internationally recognized standards, as recommended in the framework. This alignment could eliminate the need for extensive performance evaluations by enabling WHO to rely more effectively on assessments already conducted by trusted regulators. Such changes would significantly shorten the prequalification process, making the approval pathway for medical devices and IVDs more similar to the streamlined, efficient processes applied to vaccines and medicines, which do not require separate performance evaluations.

The Medical Device Single Audit Program allows an auditing organization recognized by the program to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of participating regulatory authorities. ⁽⁷⁰⁾US Food and Drug Administration. Medical Device Single Audit Program (MDSAP); available at: www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap. Participating members, including Australia, Brazil, Canada, Japan and the United States, share a standardized dossier that companies can use to meet the regulatory requirements in multiple countries simultaneously.

Despite these efforts, LDCs still face several challenges in fully implementing regulatory reliance and good regulatory practices.

Resources for LDCs are limited, as evidenced by the input gathered during interviews with stakeholders. LDCs often lack adequate infrastructure to support regulatory activities and to ensure regulatory authorities can effectively rely on and use international regulatory decisions.

A regulatory expert at a global medical device company who is also a former regulator explained that, on average, it takes about 18 months for a medical device company to obtain market authorization in primary markets. The length of time varies, depending on the primary market involved, the device’s risk classification, readiness of the regulatory dossier, maturity of the technology, robustness of the technology’s testing and strength of the clinical evidence. It takes companies another two to five years to obtain market authorization for use of their products in additional countries that are not aligned with international standards and do not practice regulatory reliance.

Some countries impose jurisdiction-specific requirements, such as unique registration requirements, in-country clinical trials, in-country lot testing, country-specific labeling requirements and prior approval in the country of origin or manufacture. These requirements can significantly delay approval.

While it may be appropriate to have jurisdiction-specific requirements, such requirements should be supported by objective scientific evidence that this practice improves safety and performance.

The added cost and time required to gather additional regulatory evidence, assemble dossiers and, in some cases, redesign the device for non-harmonized markets, sometimes disincentivizes companies from entering these markets.

The regulatory expert said that use of reliance practices can shorten the timeline needed to obtain market authorization to around 30 to 60 days, compared with two to five years for non-harmonized and non-reliance markets. Countries that pursue regulatory harmonization and/or reliance are more likely to gain access to new medical technologies.

In many instances, countries that practice regulatory reliance and harmonization have found that the average approval time has been shortened considerably. ⁽⁷¹⁾Xu M, et al. (2022). Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific. BMJ Global Health; available at: https://pubmed.ncbi.nlm.nih.gov/35985696/. Equally, the same measures could encourage local innovators in the target country to develop new medical devices for their own market and regional/global markets.

LDCs often face challenges related to harmonization of their regulatory frameworks, particularly in the medical and pharmaceutical sectors. ⁽⁷²⁾T. Sithole, et al. (2021). Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Frontiers in Medicine; available at: https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.742200/full. Ineffective product registration systems, poor inspection practices and inadequate access to quality control laboratories are some of the challenges faced by regulatory systems in LDCs. In addition, regulatory agencies in LDCs responsible for medical technology may struggle to identify and retain specific engineering and technical expertise to appropriately evaluate medical technology safety and efficacy.

To address these challenges and to increase the capacity of these countries to regulate medical products and to encourage harmonization, many regional harmonization strategies have been created. Some of these initiatives include the following:

• Asia Pacific Economic Cooperation Life Sciences Innovation Forum Regulatory Harmonization Steering Committee: Established by Asia-Pacific economic cooperation leaders, under this forum, the Regulatory Harmonization Steering Committee promotes regulatory harmonization by engaging with regulatory authorities. One of the priority work areas of this committee is the medical devices sector. Under this work area, the committee is looking into conducting training on regulatory revision and convergence. ⁽⁷³⁾Asia-Pacific Economic Cooperation. (n.d.). About Us; available at: https://www.apec.org/rhsc/about-us.

• Pan American Health Organization (PAHO): To support the process of pharmaceutical regulatory harmonization in the region, PAHO and local regulatory authorities in the Americas created the Pan American Network for Drug Regulatory Harmonization. ⁽⁷⁴⁾Pan American Health Organization. (n.d.). The Pan American Network for Drug Regulatory Harmonization (PANDRH); available at: https://www.paho.org/en/pan-american-network-drug-regulatory-harmonization-pandrh.

• African Medicines Regulatory Harmonization (AMRH): Aims to strengthen regulatory capacity and encourage harmonization of regulatory requirements in the African Union. Moreover, its Medical Devices Technical Committee aims to establish a harmonized medical devices framework for regulation in Africa. ⁽⁷⁵⁾African Medicines Regulatory Harmonization. Who We Are; available at: https://amrh.nepad.org/amrh-microsite/who-we-are.

These initiatives have yielded positive results in several LDCs and developing countries. For instance, as part of the AMRH initiative, the East African Community went from an average registration process length of a few years to less than 10 months – a substantial improvement. ⁽⁷⁶⁾J.M. Mwangi. (2016). Towards African Medicines Regulatory Harmonization: The case of the East African Community. Pharmaceuticals Policy and Law; available at: https://ifpma.org/wp-content/uploads/2023/01/i2023_9.-African-Medicines-Regulatory-Harmonization-AMRH-EAC.pdf.  ⁽⁷⁷⁾M. Ndomondo-Sigonda and A. Ambali. (2011). The African medicines regulatory harmonization initiative: rationale and benefits. Clinical Pharmacology & Therapeutics; available at: https://pubmed.ncbi.nlm.nih.gov/21252936/. Covering 85 percent of countries in Sub-Saharan Africa, the initiative has been implemented in the Economic Community of Central African States and the Economic Community of West African States. ⁽⁷⁸⁾M. Ndomondo-Sigonda, et al. (2021). Harmonization of Medical Products Regulation: A Key Factor for Improving Regulatory Capacity in The East African Community. BMC Public Health; available eat: https://doi.org/10.1186/s12889-021-10169-1.

Financial incentives

Financing is one of the most critical factors in driving MedTech innovation worldwide. As high-end MedTech is capital intensive and investors may view LDCs as risky, financing presents a major challenge for development and innovation in LDCs.

While the development of MedTech holds immense potential to address healthcare needs, the process is often financially demanding and involves long timelines, high R&D costs, lengthy and complicated regulatory processes and a substantial risk of failure. Innovators can face several barriers, such as securing initial capital, navigating regulatory approvals and obtaining market access. These challenges are significant across the globe but are particularly pronounced in LDCs, where financing options tend to be limited, and the innovation ecosystem lacks the support and incentives typically available in more developed markets.

In LDCs, the lack of financing has been identified as a major challenge and is even identified as a bottleneck that precludes some medical innovators, usually physicians, from becoming entrepreneurs. ⁽⁷⁹⁾H. Thorsteinsdottir, et al. (2021). Cultivating Small and Medium-Sized Firms: Entrepreneurship Development, Gender, and Technology in Bangladesh, Cambodia, Ethiopia and Senegal. United Nations Technology Bank for the Least Developed Countries, International Development Research Centre; available at: https://www.un.org/technologybank/sites/www.un.org.technologybank/files/cultivating_smes_report_2021.pdf. This financial gap also hinders progress toward achieving Sustainable Development Goal 3, which focuses on ensuring healthy lives and promoting well-being for all. By improving access to financial incentives for MedTech startups, LDCs can empower local innovators to develop local solutions that address urgent healthcare needs, ultimately contributing to achieving the broader agenda of universal health coverage, improved healthcare systems and equitable access to MedTech.

Long timelines may dissuade investors

Many investors may perceive innovations from LDCs as too risky and may be dissuaded from bringing new ideas to market by long timelines (which can extend up to 20 years) and a high chance of failure. ⁽⁸⁰⁾East Africa Biodesign. (2024). Health Tech in East Africa: An Ecosystem Overview. While established firms typically have access to large funds and startups typically have access to various types of early-stage funding, including seed capital, angel investors and small grants that are tied to specific activities, smaller firms may find it significantly more difficult to secure the financing that is needed for scaling up and commercialization.

The venture capital market’s potential in LDCs also remains relatively unexplored. ⁽⁸¹⁾United Nations. (2022). LDC Insight #5: Four current trends in the African least developed countries’ startup world; available at: https://www.un.org/technologybank/fr/node/1192. This missing middle in funding – where entrepreneurs are beyond the seed stage but not large enough to attract major investments – poses a substantial barrier. ⁽⁸²⁾See Thorsteinsdottir, et al..; op. cit. As a result, many promising innovations struggle to reach the market, further exacerbating the challenges faced by innovators in LDCs. Without access to sufficient medium-term financing, innovators find that it is increasingly difficult to develop and commercialize impactful MedTech on a broad scale.

There are three main types of project funding that are most often leveraged in the MedTech innovation process:

• Grants, prizes and any other sources of funding that are given to projects without an expectation of ownership being given to the funder in return, for example national innovation funds.

• Debt financing; and

• Equity-dilutive funding, including venture-capital investments and similar funding methods that provide financial support in exchange for partial ownership of the project.

Several of the stakeholders interviewed for this study highlighted the financial challenges faced by local entrepreneurs. They noted that the practice of offering grants to innovators is not as culturally embedded in LDCs as it is in other regions, and systematic efforts to provide funding remain limited.

While the long development timelines for MedTech are a contributing factor, stakeholders interviewed pointed out other, broader issues within the innovation ecosystem. The demand from hospitals for new technologies, limited commercialization efforts by innovators and insufficient incentives for early-stage public funding all contribute to the scarcity of grants.

In developed countries with robust innovation ecosystems, it can take three to eight years to bring a new medical device to market, potentially longer for more complex devices. ⁽⁸³⁾A. Lasso, (n.d.). 3 Ways to Speed Up the Medical Device Development Timeline. Jabil Healthcare; available at: https://www.jabil.com/blog/healthcare-product-development-cycle.html#:~:text=Historically%2C%20the%20medical%20device%20development,shaking%20up%20the%20status%20quo. The stakeholders interviewed proposed that this timeline would be even further extended in LDC environments where innovation ecosystems may be less developed and infrastructure/capacity-based delays in certain activities may occur (e.g., IP/regulatory submission review). In addition to the lack of public funding and limited capacity to undertake R&D projects, these extended timelines may discourage private funders who want to see the impact of their grants quickly.

Regardless of the reason for the dearth of grant funding, the outcome is that most sources of project funding in LDCs are loans or dilutive investments (funds provided in exchange for equity).

The stakeholders interviewed mentioned that dilutive investments are typically more challenging for entrepreneurs in LDCs compared to entrepreneurs in developing and developed countries. In LDCs, it is less common for prospective investors to take IP into account when determining a company’s value. This risk-focused and conservative valuation of intangible aspects of the business model can lead to a lower valuation of assets. That, in turn, can lead to companies in LDCs being less valued by investors. The result can be that investments in LDCs can command more equity than they would be able to command in developing or developed countries, where IP assets are more often taken into account.

Loss of operational control is a risk

This results in innovators in intangible asset-intensive industries needing to dilute their ownership of the company to raise funds to the point that they may lose operational control. This diluted ownership may discourage entrepreneurs from pursuing innovation, as it reduces the potential rewards for the risks they take.

The commercialization experts we interviewed mentioned that, in certain geographies, IP can be used as collateral for bank loans, allowing entrepreneurs to obtain funds without diluting their equity. However, they also said that this is not a common practice in LDCs. A key reason may be that few innovators secure IP in these geographies and, as a result, the stakeholders typically have limited experience in their enforcement. Another reason may be that infrastructure needed to develop IP commercialization strategies is limited. We interviewed some experts who provide loans and grants in LDCs. These experts said that, while they do not accept IP as collateral for loans, they do evaluate the status of the company’s IP portfolio and the country’s IP ecosystem when deciding whether to invest in a project.

Financing is also an issue for MedTech innovation and access to business models in LDCs, where the high cost of imported MedTech products can act as a market barrier. ⁽⁸⁴⁾M. Razworthy, et al. (2022). Biomedical Engineering as a Driver for Healthcare Improvements in East Africa. University of Leeds; available at: https://eprints.whiterose.ac.uk/id/eprint/196342/7/BME-Driver_Report_Final_Digital.pdf. A number of experts interviewed for this study said that, for a project to be financially sustainable and attractive for global companies, the market must be large enough to justify the costs of entering it. This is sometimes challenging in LDCs, where the population may be relatively small, and infrastructure may be sub-optimal when it comes to access to medical services as well as to services and public utilities more broadly.

In addition, poor reimbursement systems may not support the financing of medical technology in the public and/or private sectors. This can be exacerbated for countries that do not practice regulatory reliance and harmonization, or for those that add unique requirements to enter the market. One way to address this is to evaluate a group of countries as a “regional market” to generate sustainable demand.

Donors have begun to support pooled procurement initiatives in Africa to make a strong business case and generate economies of scale. This method presupposes a degree of trade and regulatory harmonization among the countries. Some entities that pursue pooled procurement initiatives include the United Nations Children’s Fund (UNICEF); ⁽⁸⁵⁾Immunization Economics. Pooled Procurement. (n.d.); available at: https://immunizationeconomics.org/wp-content/uploads/2017/12/BRIEF12.pdf. Gavi, the Vaccine Alliance; ⁽⁸⁶⁾Gavi. (2024). Gavi’s approach to engaging with middle-income countries; available at: www.gavi.org. https://www.gavi.org/types-support/sustainability/gavi-mics-approach. and the Global Fund ⁽⁸⁷⁾The Global Fund. (2023). Operational Policy Note: Pooled Procurement Mechanism Process Objective; available at: https://www.theglobalfund.org/media/13720/gmd_pooled-procurement-mechanism_opn_en.pdf..

Experts from multinational MedTech companies stressed the importance of considering specialized market-access strategies to be able to expand access. For example, laboratory equipment has historically been more accessible than medical devices because MedTech companies utilize innovative market entry strategies to make solutions more accessible and affordable.

Placement contracts and phased market entry in LDCs

One example is the placement contracts model, which provides equipment to a medical facility at no cost in exchange for the company being the exclusive supplier of other consumables to that same facility. Placement contracts usually have a three- to five-year duration, which is typically long enough for the medical facility to pay for the equipment in multiple tranches over time, rather than paying the full amount up-front. ⁽⁸⁸⁾M. Zander. (2021). Medical and Laboratory Equipment Landscape in East Africa. Africon; available at: https://www.spectaris.de/fileadmin/Infothek/Verband/Au%C3%9Fenwirtschaft/Internationale-Zusammenarbeit/2021-10-31_Medical_and_laboratory_equipment_landscape_in_East_Africa_-PPT.pdf. This system could work well for larger or more specialized capital equipment that might not otherwise be affordable to hospitals in LDCs.

One stakeholder said that affordability and lack of reimbursement represent the main access challenges in emerging markets. The funding level of national healthcare systems also presents a constraint, with a majority of the population in LDCs paying out of pocket for a high percentage of their medical services and use of technologies.

On average, out-of-pocket expenses account for about 48 percent of the current health expenditure in LDCs, and only around 13 percent of current health expenditure in high-income countries. ⁽⁸⁹⁾World Bank Group. (2024). Out-of-pocket expenditure (% of current health expenditure) – Least developed countries: UN classification, High income; available at: https://data.worldbank.org/indicator/SH.XPD.OOPC.CH.ZS?locations=XL-XD. In certain instances, this reliance on out-of-pocket payments can negatively affect access to medical care. ⁽⁹⁰⁾M. Jakovljevic, et al. (2021). Editorial: Health Financing and Spending in Low- and Middle-Income Countries. Frontiers in Public Health; available at: https://doi.org/10.3389/fpubh.2021.800333.

Another stakeholder mentioned entering a new market in multiple stages. In the first stage, the company focused on addressing the needs of the most accessible patients (patients in urban settings with private insurance). During this stage, the goal was to become established within the country’s reimbursement system; to increase awareness of the specific MedTech product; and to provide trainings to healthcare providers on how to use the new technology. Once these baseline requirements were met, adoption and demand gained traction/reached critical mass as more patients learned about the product and healthcare providers became more comfortable with using it to provide improved healthcare.

At this stage, the company could more easily work with the local government to make its solution accessible to as many patients as possible and was able to reach far more patients than it would have had it tried initially to reach every hospital and health clinic.

Product-market fit of MedTech in LDCs

Product-market fit in MedTech means developing a solution that effectively addresses the needs of patients while also aligning with the expectations of healthcare providers, payers and regulatory bodies. There are ten main types of issues that affect the product-market fit of MedTech in LDCs: availability, appropriateness, functionality, affordability, spare parts, personnel, infrastructure, medical training, management/public policy and culture. ⁽⁹¹⁾A. Gauthier, et al.. (2013). Design factors for medical device functionality in developing countries. IISE Annual Conference Proceedings. pp. 2227-2236.

Availability

Availability relates to how obtainable a device or its components may be and affects both the product-market fit of the device in a healthcare setting and the capacity to manufacture MedTech within certain regions. For example, single-use, plastic speculums are more cost-effective and carry a lower risk of contamination than reusable metal ones. ⁽⁹²⁾GD Medical. (n.d.). Vaginal Specula: Single-Use vs. Reusable; available at: https://gdmedical-live-c3e9de9e28d24f19bbce309-e76bdbf.aldryn-media.com/filer_public/14/32/143216cc-673c-446b-9368-edc47a8d059e/obp_vaginal_specula_single_use_vs_reusable_10818.pdf. However, in clinics located in areas with poor transportation infrastructure, it can be difficult to restock these single-use items, making their use impractical in such settings. Single-use devices, devices with consumable components and products that require cooling during transportation are all less suitable for these environments than are products that are reusable and temperature stable.

As another example, if country officials want to improve their local manufacturing capacity but do not have reliable access to subcomponents, they will not be able to consistently produce high-quality MedTech products.

Appropriateness

Appropriateness has to do with the suitability of the device in the physical or cultural environment where it would be used. For instance, in areas with frequent power outages, battery-operated devices are more practical than are those that require a constant external power supply.

Similarly, cultural norms of modesty in some communities can make women uncomfortable interacting with male providers or undergoing invasive procedures like mammograms or Pap smears. In such cases, it is imperative to adjust the care provided to meet their needs. ⁽⁹³⁾C. Andrews. (2006). Modesty and healthcare for women: understanding cultural sensitivities. Community Oncology, 3(7), 443–446.  ⁽⁹⁴⁾Cardiovascular Medicine. (n.d.). The ECG leads: electrodes, limb leads, chest (precordial) leads, 12-Lead ECG (EKG); available at: https://ecgwaves.com/topic/ekg-ecg-leads-electrodes-systems-limb-chest-precordial/.  ⁽⁹⁵⁾J. Madias. (2003). A comparison of 2-lead, 6-lead and 12-lead ECGs in patients with changing edematous states: implications for the employment of quantitative electrocardiography in research and clinical applications. Chest; available at: https://pubmed.ncbi.nlm.nih.gov/14665478/.

Functionality and affordability

Functionality relates to whether a device works properly. For example, LDC patients with above-the-knee leg amputations often find state-of-the-art prosthetics cost prohibitive but may experience poor quality and unreliable performance with low-cost devices. The makers of these prosthetics cut costs by reducing functionality. They often use a single-axis knee joint design, which is less stable and provides less toe clearance when walking compared to a normal knee. The low-cost ReMotion JaipurKnee is a polycentric prosthetic knee – it works like a human knee and performs like devices in high-income countries. The JaipurKnee has seen success in low-income areas, with 79 percent of patients continuing to use the prosthetic six months after fitting and 95 percent of patients reporting good performance with no failures. ⁽⁹⁶⁾S. Hamner, et al.. (2015). ReMotion Knee: Scaling of an Affordable Prosthetic Knee for Developing Countries. Technologies for Development. pp. 137–151; available at: https://doi.org/10.1007/978-3-319-16247-8_14. Therefore, multiple technologies often support the same function, but differ in cost, durability and user experience. Choosing the right technology involves balancing these factors while ensuring the core functionality meets patient needs.

Spare parts

Spare parts refer to the cost and effort needed to maintain and repair equipment. Factors that exacerbate the use and maintenance of a device in an LDC setting include using custom parts instead of off-the-shelf components and requiring a high level of skill to maintain and repair the equipment.

Personnel, infrastructure and medical training

References to personnel denote both the level of training needed to operate or implant the MedTech product as well as the number of personnel required to facilitate its usability in an LDC setting. If a MedTech product requires multiple trained personnel but the hospital is routinely understaffed, the product is less likely to be used even if it is available. This underscores the impact of human resources on the product-market fit of MedTech.

Management/public policy

Management/public policy reflects the triple helix model of innovation in discussing the extent to which the local government regulates the use of a device. This can be a barrier if there is either not enough or too much regulation on MedTech. Under regulation reduces reliability in the quality of products on the market. Overregulation can stifle innovation, making it difficult for new products to enter the market. Government officials who know how to properly regulate the technology greatly enable the MedTech sector to thrive.

Culture

Finally, culture refers to the differences in mindsets/approaches to treatment between the setting in which the technology was developed and the setting in which it will be used. Populations that tend to go to traditional healers for specific treatments may not pursue care in a hospital or clinic even if the needed devices and staff trained to operate these devices are available there. For example, in Ethiopia, cervical cancer patients tend to prefer traditional remedies and to perceive modern treatments as having few benefits, often causing delays in access to modern care. ⁽⁹⁷⁾Z. Birhanu, et al. (2012). Health seeking behavior for cervical cancer in Ethiopia: a qualitative study. International Journal for Equity in Health; available at: https://doi.org/10.1186/1475-9276-11-83.

The ten factors discussed above affect the product-market fit of MedTech in LDCs by contributing to barriers in workforce training, local uptake and use of products and local manufacturing capacity. Anticipating and addressing these factors is an important part of increasing capacity for MedTech innovation and access in LDCs.

Workforce training

Unlike most pharmaceutical-based solutions, MedTech solutions often evolve rapidly and require up-to-date skills and training. Frontline healthcare providers, including doctors, nurses and technicians, play a pivotal role in MedTech innovation, not only as inventors themselves, but also as essential stakeholders throughout the entire development process. Their frontline experience allows them to identify unmet clinical needs, ideate practical solutions and assess the appropriateness and feasibility of new technologies. Importantly, they work closely with biodesign engineers, combining clinical insight with technical expertise to co-develop effective, user-friendly MedTech. They are also instrumental in deploying and administering MedTech and providing ongoing feedback, ensuring that innovations are both safe and impactful in real-world healthcare settings. Lack of trained doctors, surgeons, technicians and nurses is one of the biggest barriers to the adoption and use of MedTech in LDCs.

Furthermore, limited awareness, lack of screening opportunities, and limited diagnosis and treatment options remain key barriers to the detection and management of NCDs. LDCs may lack trained cardiologists and endocrinologists to diagnose and treat heart disease and diabetes, for example. In settings like this, the capacity to both innovate and appropriately use MedTech solutions will be correspondingly low.

In addition, healthcare providers who do not have sufficient training on how to use equipment properly will not adopt technologies that could dramatically increase the quality of care for their patients. Even in Ghana, a developing country, lack of medical training resulted in 18 percent of hospitals not stocking pediatric chest tubes in their facilities. ⁽⁹⁸⁾J. Ankimah, (2015). Strategic Assessment of the Availability of Pediatric Trauma Care Equipment, Technology and Supplies in Ghana. Journal of Pediatric Surgery; available at: https://pubmed.ncbi.nlm.nih.gov/25841284/. When training opportunities are provided, the MedTech access gap is addressed and the adoption of medical technologies increases. In Ethiopia, an LDC, training healthcare providers in the use of surgical devices led to a 50 percent increase in surgical services provided and reduced surgical mortality by 33 percent over a seven-year span. ⁽⁹⁹⁾Safe Surgery 2020. (n.d.). Overview; available at: https://www.pgssc.org/safe-surgery-2020.

There are unique considerations for the local manufacturing of advanced MedTech, such as the need for specialized talent, scalability, market demand and high-capital investments. WHO estimates that in some developing countries about 80 percent of all medical devices are donated or funded by donations. ⁽¹⁰⁰⁾World Health Organization. (2024). Medical device donations: Consideration for Solicitation and Provision. WHO Medical Device Technical Series; available at: https://www.who.int/publications/i/item/9789240093621. However, only 10 to 30 percent of donated equipment becomes operational in the recipient country, ⁽¹⁰¹⁾World Health Organization. (‎2010)‎. Barriers to Innovation in the Field of Medical Devices: Background Paper 6. World Health Organization. https://iris.who.int/handle/10665/70457. and less than 50 percent of all laboratory and medical technology (regardless of origin of procurement) is usable. ⁽¹⁰²⁾World Health Organization (2024); op. cit. Often, this is due to lack of user training and lack of knowledge on how to repair and maintain devices. ⁽¹⁰³⁾World Health Organization (2024); op. cit.

In some instances, MedTech is not usable due to a lack of local technicians with adequate skills to repair broken equipment. ⁽¹⁰⁴⁾R. Malkin. (2007). Barriers for Medical Devices for the Developing World. Expert Review of Medical Devices; available at: https://pubmed.ncbi.nlm.nih.gov/18035940/. One study found that 72 percent of the capital equipment classified as “failed” in resource-poor settings could have been repaired and placed back into service without needing to import any parts. ⁽¹⁰⁵⁾R. Malkin and A. Keane. (2010). Evidence-based approach to the maintenance of laboratory and medical technology in resource-poor settings. Medical & Biological Engineering & Computing; available at: https://doi.org/10.1007/s11517-010-0630-1. Often, the main issue obstructing use of the device was lack of proper installation or user training. ⁽¹⁰⁶⁾Ibid. In 66 percent of cases, the equipment could have been repaired with “far less knowledge than that required of a biomedical engineer or biomedical engineering technician,” suggesting that providing training equivalent to the skillset of a biomedical technician’s assistant could return into service two-thirds of out-of-service MedTech products, ⁽¹⁰⁷⁾Ibid. and increase the total amount of MedTech in service from less than 50 percent to around 80 percent. This underscores the vital role played by frontline healthcare providers, not just as users of technology, but as key contributors to the innovation ecosystem who can identify recurring challenges, inform design improvements and help ensure technologies are context-appropriate and sustainable.

MedTech companies know more about their own products than anyone else and therefore have an ideal opportunity to address access issues and increase the adoption of MedTech through training and education programs. Most large MedTech companies already provide training and education services to healthcare providers, empowering them to harness MedTech innovations and improve health access. For example, in the years 2020 and 2023, Medtronic trained 993,000 healthcare providers. ⁽¹⁰⁸⁾G. Martha. (2023, September 25). Strengthening Healthcare Resilience Through Education and Training [Post]. LinkedIn. https://www.linkedin.com/pulse/strengthening-healthcare-resilience-through-education-geoff-martha/. These training courses can drive significant improvements in care around the world (see Box 4).

Government and company investment in the education and training of physicians, engineers and technicians can help healthcare systems to become more resilient; improve quality of care; and increase MedTech innovation and access.

Local manufacturing challenges and use

The majority of MedTech products are imported into LDCs from innovator companies in the United States and Europe. Currently, there is limited capacity in LDCs to manufacture advanced medical technologies. While low-cost MedTech products are produced locally, over 70 percent of stents and MRI machines are imported by LDCs. Unlike drugs, these products cannot be produced locally through reverse engineering. While some governments are keen to encourage local production in the MedTech sector, several obstacles remain. In LDCs, these obstacles often include security, climate, communications, power supply and transport issues; they make it more challenging both for international entities to set up local operations and for local startups to deliver their products to patients. ⁽¹⁰⁹⁾Zander (2021), op. cit.

During interviews, several stakeholders cited challenges associated with setting up local manufacturing. A few stakeholders said that global MedTech companies have well-established manufacturing sites with high-quality control standards and that it would take exceptional circumstances to set up new facilities in a country that doesn’t already have existing facilities. They said that it takes 18 to 24 months to evaluate new locations for manufacturing and another 24 months to build the site. Additionally, they are subject to high regulatory scrutiny to qualify as suppliers, which takes an additional nine to 18 months to complete. Interviewees said that this investment of time and resources does not necessarily improve access. While some vaccine manufacturing supply chains are simple and short, MedTech products often comprise hundreds of subcomponents made of thousands of materials. Setting up a completely new MedTech supply chain in a new country can be challenging because it requires access to a reliable supply of hundreds of high-quality subcomponents. One company said that each of its ventilators contains 1,500 parts from 100 manufacturers in 14 countries.

Regionalizing manufacturing is inefficient

Stakeholders across different companies also mentioned that, while vaccines are manufactured in high volumes because they need to reach entire populations, MedTech products need to reach a very specific group of patients. One interviewee presented the example that imaging products (CT scanners, MRIs, X-ray machines, etc.) are manufactured in quantities of a few thousand units per year and are made to order for specific clients. Due to the low production volumes, regionalizing manufacturing to meet local demand is inefficient; instead, these products are sold globally, making “the whole world our market,” the interviewee said.

Some of the stakeholders interviewed said that their organizations had reduced their presence in LDCs due to issues with payments, agreements and manufacturing capabilities that did not allow for sufficient scaling. They also cited concerns over high staff turnover in LDCs that made it difficult to retain institutional knowledge about complex devices and therefore challenging to manufacture these devices successfully.

Additionally, interviewees said it was sometimes hard to confirm that local companies can meet the necessary quality and safety standards, such as sterilization capacity, because local facilities may not have certification from the International Organization for Standardization. Experts recommended that if a country would like to increase its regional manufacturing capacity, it should focus first on building expertise and a reputation as a reliable manufacturer of subcomponents. This would allow the country to increase its technical capacity and business capacity, which would allow local manufacturers to evolve into developers of more complex technologies.