Intellectual property
Public sector:
There is a general lack of awareness about different forms of IP protection, filings and enforcement systems.
Investing in the hiring and training of sufficient administrative staff and examiners is critical to building a robust IP ecosystem.
It is crucial for countries to build trust in their enforcement and efficient management of IP processes so that the private sector will increase their utilization of the system.
Private sector:
A country’s IP system can become more efficient and effective only if it is utilized. The more companies engage with the IP ecosystem, the stronger it becomes, incentivizing innovation and entrepreneurship and reducing the likelihood of infringement and counterfeiting.
Local manufacturers should explore the possibility of in-licensing MedTech from other local and overseas providers.
It is important to support the development of TTOs and policies in universities to bridge the gap between the private sector and academia.
Regulatory systems
Public sector:
Countries that adhere to international standards and best practices benefit from faster access to MedTech. This is because global MedTech companies can leverage existing regulatory dossiers.
Lack of differentiation between pharmaceutical and MedTech regulation can slow down innovation by applying overly rigid or inappropriate requirements to MedTech. MedTech products often have shorter development cycles, different risk profiles and distinct testing needs compared to pharmaceuticals.
Without a tailored, regulatory pathway, MedTech innovators face delays and barriers that hinder the development, adaptation and timely market entry of new health solutions.
Regulatory harmonization and reliance are not only effective ways to streamline approvals but also represent opportunities to build and enhance local authorities’ regulatory skills and capacity. This is particularly beneficial in environments where the regulatory ecosystem is still maturing, as it allows for the adoption of best practices and standards without the need for extensive local resources.
Imposing unique, country-specific requirements to enter a given market (e.g., requiring country-specific inspections instead of utilizing recognized Quality Management System evidence such as Medical Device Single Audit Program audit reports or ISO 13485 certification to ensure medical devices manufacturers adhere to the relevant international standards) can make it more challenging to attract global MedTech companies. This regulatory burden is especially difficult for domestic innovators, who often lack the resources to navigate complex approval pathways.
Private sector:
Stakeholders in the private sector should determine which LDCs practice regulatory harmonization and reliance, because it will be easier to provide services to these countries by streamlining or decreasing the time it takes to prepare regulatory dossiers.
Stakeholders should engage in ongoing dialogues with governments of LDCs to highlight the challenges posed by non-harmonized regulatory environments and to illustrate how unique regulatory requirements affect MedTech access and reduce the attractiveness of different markets to companies.
Stakeholders should actively participate in government-led policy dialogues to ensure that, prior to policy formulation, the private sector is heard and considered.
Financing
Public sector:
The gap in mid-sized, unrestricted funding opportunities for local entrepreneurs is making it more challenging for innovators to succeed.
Tax incentives like the ones established in Rwanda and Bangladesh can help promote MedTech access by facilitating device imports.
Government funding through industrial policy grants, innovation centers and interest-free loans can support young innovators to access capital in the MedTech sector.
Private sector:
When officials who manage funds and banks consider intangible assets like IP in company valuations and loan collateral agreements, innovators are more easily able to access necessary funding to achieve their project goals.
Venture capital plays a crucial role in supporting MedTech innovation in LDCs by providing the funding and resources they need to grow and scale their solutions. Global MedTech companies may benefit from utilizing creative business models to help widen access to their products.
Public-private partnerships can pool financial, human and technical resources to support the growth of the local MedTech sector.
Capacity
Public sector:
It is important to invest in training programs for all stakeholders (e.g., surgeons, doctors, nurses, regulators and policy makers) in MedTech development, regulation, utilization and deployment.
Identifying and addressing causes of brain drain and employee turnover can support the development of the local innovation ecosystem; encourage local innovation led by doctors and engineers; and make countries more attractive to global MedTech companies seeking to set up operations.
Technology transfer projects can be tools to develop local manufacturing capacity
Private sector:
Companies can exert a dramatic impact on MedTech access by building partnerships with local organizations to provide training and education opportunities for healthcare providers.
Engaging in technology transfer projects with local partners can be useful in providing value for patients in situations where the company would not otherwise have been able to meet patient needs on its own.
Products and product support systems (e.g., maintenance technician training) that are designed with the country’s ecosystem in mind are more likely to succeed.