Bangladesh
Intellectual property
Public sector
To support a smooth transition toward graduation from LDC status, ensure that national IP laws are aligned with international standards and strengthen IP protection and enforcement mechanisms.
Continue providing financial and infrastructure support (including incentives and subsidies) for companies investing in research and development.
Develop robust national IP policies and enforcement mechanisms to garner national and international trust and investor confidence in the national IP system.
Establish, support and promote research centers in universities, TTOs and other institutions working in MedTech innovation.
Provide education and training to healthcare stakeholders on the different aspects of IP, including conducting patent searches, filing patent applications, IP valuation, and IP commercialization support. This will help local inventors access funding and scale up their innovations in the MedTech sector.
Private sector
Officials at private universities, innovation hubs and incubators should consider offering guidance on patent filing to support first-time innovators engaging with the system.
Companies should prioritize partnerships with academic institutions, research organizations and startups to leverage combined expertise and resources to develop patentable MedTech products.
Incubators should consider providing funding or grants specifically aimed at covering IP-related costs.
Regulatory systems
Public sector
Consider the merits of introducing a dedicated regulatory body for medical devices, within the Directorate General of Drug Administration, to provide necessary oversight to address the gap in technical expertise. There would be benefits to this body operating based on internationally recognized standards and best practices to ensure global convergence and regulatory reliance. This would enable Bangladesh to serve as a model for other LDCs.
Encourage regulatory enforcement and seek technical assistance from international organizations to ensure regulatory bodies have the necessary resources and expertise. This could include adopting reliance practices that allow leveraging assessment from mature regulatory authorities.
Develop mechanisms that allow regulatory bodies to support responsible innovation while maintaining high standards for safety and effectiveness.
Private sector
Invest in appropriate capacity-building initiatives in partnership with government and relevant international organizations for regulatory officers to improve their knowledge of MedTech regulation. Training should focus on international best practices, convergence and reliance principles to ensure alignment with global regulatory standards.
Support regulatory science and research that can serve as a scientific basis for developing regulations and standards. Encourage collaboration between industry and regulatory bodies to foster innovation and create a robust regulatory framework grounded in evidence-based practices.
Financing
Public sector
Further support government initiatives like the Hi-Tech Park that provide incentives and attract foreign investment into the technology industry.
Further promote and replicate the success of initiatives like Startup Bangladesh Limited and the Innovation Design and Entrepreneurship Academy, which provide funding to technology-based innovations.
Private sector
Allocate grants to incubators and technology parks working on health technologies.
Local innovators should take advantage of government-backed initiatives like StartUp Bangladesh Limited to obtain funding for their projects.
Capacity
Public sector
Continue developing initiatives such as the High-Tech Park to support entrepreneurs and help develop a MedTech ecosystem in collaboration with the Ministry of Health and Family Welfare.
Private sector
Nurture the innovation ecosystem by developing networking platforms where local entrepreneurs, investors and experts in the MedTech field can connect and collaborate.
Rwanda
Intellectual property
Public sector
Consider creating training programs tailored to increasing awareness of IP for non-IP professionals in different government agencies affecting the MedTech sector, including health, commerce, science and information and communications technology ministries.
Continue providing assistance/education on IP to personnel in law enforcement agencies, IP and regulatory offices, students in STEM, innovators and entrepreneurs.
To address the issue of fewer patent filings and limited capacity:
Investigate the underlying causes by identifying gaps in existing training programs; assessing the availability of resources and expertise; and understanding challenges faced by innovators and IP professionals in this area.
Develop effective solutions to train innovators and lawyers in patent drafting through specialized workshops, mentorship programs, online courses, or partnerships with experienced patent professionals.
Private sector
Local innovators and entrepreneurs should explore the benefits of patents, utility models and industrial designs in addition to trademarks in order to fully leverage the potential of IP.
By diversifying their IP portfolio, innovators can better protect their innovations, secure a competitive advantage, potentially generate additional revenue streams and contribute to the fight against infringement and counterfeiting.
Local innovators and entrepreneurs should consider how they can benefit from IP training and assistance provided by NIRDA and WIPO to enhance their understanding of IP and become more confident in engaging with IP-related matters.
Regulatory systems
Public sector
Continue creating distinct regulatory procedures for devices and diagnostics to ensure that the unique requirements and challenges of devices and diagnostics are adequately addressed.
Continue practicing harmonization with international standards and best practices and enhance regulatory reliance, including increased use of reliance for multinational companies entering the country, particularly for devices that have undergone stringent regulatory assessment (e.g., by Management Committee members of the International Medical Device Regulators Forum).
Private sector
Take advantage of the Rwanda FDA’s regulatory reliance framework to facilitate dossier submissions and expedite access to essential MedTech for the local population.
Financing
Public sector
Recognize IP as an important asset:
to create avenues for financing;
to introduce fee concessions for individual applicants and SMEs;
to create institutional frameworks enabling IP owners to leverage their IP as assets
Continue to engage with global partners, including international organizations, government agencies and philanthropic organizations to further advance Rwanda’s health policy objectives by leveraging financing instruments.
Private sector
Funders, donors and investors should consider maintaining continuous support for projects in the MedTech sector as they play a vital role in driving innovation and long-term progress.
Innovators and entrepreneurs should make active efforts to meaningfully collaborate with the public sector and funders to communicate their needs and suggestions.
Capacity
Public sector
Initiatives by NIRDA (such as investing in STEM laboratories
(1)NIRDA. (n.d.). NIRDA to Invest $82M in STEM Lab; available at: https://www.nirda.gov.rw/home/news-detail?tx_news_pi1%5Baction%5D=detail&tx_news_pi1%5Bcontroller%5D=News&tx_news_pi1%5Bnews%5D=42657&cHash=37580c201e470dbfe0eba59f9d15487b. ) are vital to increasing innovation capacity and capacity for domestic prototyping capabilities rather than relying on prototyping facilities outside of the country.Consider adopting a more practical and hands-on approach to training, so that entrepreneurs are equipped with the mental framework for how to approach innovation.
Promote research into the most important health areas following the triple helix model of innovation.
Private sector
Focus investment and reform efforts to address infrastructure challenges that can inflate production costs (such as high cost of water) and build facilities to enable prototyping and local manufacturing.
Invest in and prioritize innovations for alternative infrastructure support projects, such as Zipline and Flutterwave. Note that telemedicine programs can also help to overcome some of the traditional infrastructure challenges and increase geographical access to health innovations.