The World Health Organization (WHO) defines health technologies as including medicines, medical devices, assistive technologies, techniques and procedures developed to solve health problems and improve the quality of life.
Within this expansive field of health technologies, medical devices represent a key subset. The term “medical devices” serves as an umbrella term, encompassing a wide range of instruments, apparatuses, machines and articles used for the prevention, diagnosis and treatment of diseases or conditions.
Advanced medical devices often contain highly engineered components with intricate specifications. The development and manufacture of these devices pose unique challenges. These include the need for specialized manufacturing capabilities; alignment with rapid technological advancements; and the continuous demand for improvement, optimization and innovation. They are also vulnerable to global supply chain disruptions.
Focus on advanced medical devices
This study focuses specifically on advanced medical devices, henceforth referred to as “MedTech.” It explores the intellectual property (IP) and innovation ecosystem required to support the growth of, and access to, the MedTech sector in least developed countries (LDCs).
Systematic analyses show that there is a higher prevalence of certain noncommunicable diseases (NCDs) (e.g., hypertension, diabetes, cardiovascular diseases, cancer and chronic respiratory diseases) in LDCs than in developing and developed countries, and simultaneously less awareness and management of these diseases due to limited detection and treatment options. NCDs are often managed with MedTech, including complex devices (e.g., insulin pumps for diabetes or pacemakers for cardiovascular diseases) or devices that require complex infrastructure (e.g., computed tomography [CT] scanners and MRI scanners for stroke diagnosis, or interventional cardiology labs for minimally invasive stent placement).
MedTech solutions scarce in LDCs
Unlike their counterparts in higher-resource settings,
The so-called triple helix model of innovation posits that both the public and private sectors drive innovation. The public sector defines and incentivizes the direction of innovation and the private sector benefits from public sector programs to make quick progress in new fields. This report analyzes both the public and private sectors and identifies enablers and barriers to MedTech innovation in LDCs. It studies multiple aspects of the MedTech ecosystem, including the MedTech innovation culture and capacity, IP system, regulatory systems, financing opportunities and policies that can promote innovation and access.
Lessons learned
This report further examines the current state of MedTech innovation and access to technologies in this sector in LDCs. It uses Bangladesh and Rwanda as case study countries to provide specific examples of ground-level realities and to extract lessons learned from their challenges and successes. It identifies opportunities to support the development of and access to MedTech products in LDCs.
This study identifies several enablers and barriers to MedTech innovation and access in LDCs in multiple areas of MedTech development:
Intellectual property
As part of their overall growth strategy, many LDCs are developing their IP systems by enacting industrial property and copyright laws, establishing IP offices and signing IP treaties. Generally, LDCs are perceived as lacking the resources necessary to manage, review, and process IP filings and to facilitate the enforcement of IP rights. As a result, they are often overlooked as IP filing destinations by global MedTech companies. Furthermore, there is often a lack of IP awareness amongst local innovators, who are often not aware of how to utilize the IP ecosystem. To address this, WIPO and government agencies in LDCs can collaborate to strengthen their efforts in training innovators, examiners from local IP offices, judges, and law enforcement officers on leveraging national IP protection to boost innovation and enhance enforcement mechanisms.
Regulatory systems
Regulatory systems in LDCs may be less mature than those in developing and developed countries, complicating the process of registering a MedTech product for in-country approval. This risks disincentivizing both local and international medical device developers from registering for in-country regulatory approval. Even if the innovators apply for approval, there is often a delay in processing applications, constituting a barrier to MedTech innovation and access in the country. Regulatory harmonization, which coordinates regulatory approval application requirements among countries, could help address this challenge. Regulatory reliance (expediting regulatory approvals in one jurisdiction based on previous approval in other countries) can also help to decrease the burden on innovators and regulatory application reviewers while local regulatory frameworks are still under development, continuing to ensure the quality and safety of devices. It is also important to recognize the differences between drugs and medical devices, which may require pursuing different regulatory pathways.
Financing
Local innovators often struggle to access sufficient funds to support early-stage development of high-end medical devices. Investors may be hesitant to engage with an underdeveloped MedTech ecosystem, seeing it as high risk, or may perceive the amount of equity requested in exchange for investment as too high. International innovators may be reluctant to enter LDC markets due to the cost of entering the market surpassing expected profits. To address these challenges, countries can design strategies to support the development of the MedTech ecosystem as a whole, including programs to attract investors and examining ways that the local government can provide incentives to encourage and support local early-stage technology development. In addition, international companies can utilize creative market strategies to facilitate more sustainable market entry.
Training and skills development
The delivery and proper use of MedTech relies on the availability not just of skilled engineers and technicians, but also of medical practitioners. Medical practitioners not only diagnose the need for the technology, but also innovate and improve existing technologies, correctly deploying them and providing appropriate follow-up, monitoring and maintenance. This is often challenging in LDC settings where the necessary human resources, including healthcare providers as well as engineers and technicians, may not be in place. This hinders both local innovation and technology adoption. To address this, governments can invest in the development of both medical and technical/engineering schools to support their countries’ changing needs. Multinational companies for their part can provide trainings for healthcare providers to increase their awareness and comfort in adopting new technologies. Additionally, infrastructure challenges can make the local manufacture of medical devices challenging. To resolve these issues, countries must improve their infrastructure and companies should consider LDC-specific needs when developing products for these markets.