Development of IVD sector – Pathways for sustainability

IVDs are expected to have a considerable impact on the health system and economy of the country. However, the technological expectations depend upon the creation of a robust ecosystem for technological development and diffusion.

Building of an effective ecosystem for the IVDs sector involves the consideration of need-based technological developments. In India, these need-based technological developments on one hand demand for potential diagnostic technologies to deal the challenge of increasing incidence of chronic diseases and highly prevalent infectious diseases. And, on the other hand, the needs are characterized by challenges of indigenization that are linked to the issues of affordability, innovation making for resource constraint settings, limited economic resources in terms of supply of finance, capital, infrastructure, skilled labor, and the problem of structural rigidities in technological regulations. These specific problems of the country must be dealt through the adoption of pathways that can direct the process of innovation to be understood as a system where system-building activities are socially shaped to deliver need-based technological interventions. Therefore, the first and foremost focus of system-building activities should be on sustainability and societal development rather than on innovation and economic growth based on market calculations.

The directionality of the performance of system-building activities is crucial for addressing the need-based challenges, and in setting or shaping the priorities for socio-technical developments. This can be achieved by ensuring:

• Strengthening and driving the domestic healthcare financing system toward target-based research and innovation to encourage indigenization;
• Providing equal opportunities to all stakeholders to participate in knowledge creation and diffusion, and to materialise the innovation process for the benefit of local needs and requirements;
• Incentivising the stakeholders to undertake collaborative research and engage interactively in performing the system building activities, as the dynamic interactive relationship between innovating actors and the institutional environment play an important role in shaping the sustainable technological progress and directions;
• System-building process should undertake the in-depth analysis of identifying the challenges of developing an environment that is conducive for innovations, which are specific and suited to meet the health system requirements of the country;
• Encouraging partnerships between academia–industry collaboration to boost translational research;
• Implantation and utilization of the health technology assessment to aid in the facilitation of determining benefits, barriers, and risks;
• Creation of repository on country’s specific diagnostic challenges associated with highly prevalent diseases, so that these challenges can be associated with the innovation making;
• Development of institutional mechanism for stringent governance and regulatory system to cease marketing of substandard diagnostics;
• Conducive market formation for the domestic firms through the creation of robust financing mechanisms by various government funding and promotional schemes, and through encouraging the PPPs; and
• Proper coordination between various ministries and departments to initiate policies for encouraging indigenous manufacturing through availability of funds, land demarked for setting up manufacturing units, tax relaxation, encouraging research and development, etc.

To conclude, for ensuring the sustainable directionality of system-building activities, there is a need to adopt challenge-led innovation policies to address the country’s specific needs. This can only be achieved by the deflection of the pathways from routine comfort zone of innovation making to the new paradigm of transformative or mission-oriented innovation policy, which addresses the need-based challenges and set the directions of sustainable socio-technical transitions. Hence, participating stakeholders would have to strengthen their capabilities and capacities to understand the prerequisites for transition of the involved regimes, sectors, and innovation systems related to technological development.