India's medical devices policy: exploring determinants in business ecosystem for export excellence.

Purpose: This paper attempts to elucidate the fundamental determinants-both enablers and impediments-that shape a resilient business ecosystem for the medical devices sector in India, with a particular emphasis on sustainable export endeavours under the ambit of the Medical Devices Policy 2023.

Design/methodology/approach: This study dives into India's medical device export firms, analysing factors influencing their performance. By reviewing relevant literature, it identifies regulatory, manufacturing, marketing, distribution and import-related factors. A Likert scale questionnaire was designed and shared with industry stakeholders to gather primary data, and it was analysed via SPSS/AMOS. This quantitative approach unveiled the direct impacts of enablers and barriers, shaping a structural model to elucidate interrelationships, thus informing strategies for enhancing India's medical device export sector.

Findings: The results lucidly identify the barriers that affect the export performance of India's medical devices, such as complicated product registration formalities, complexity in the registration and approval process for sale, export restrictions and price control measures, local competition and policies, finance and investment challenges and low knowledge and expertise in the trade of medical devices. Considering the relevance of these barriers in affecting India's export achievement, a model is derived for understanding their interrelationship, exploring causal links and comprehending managerial and policy-level implications for suitable corrective actions.

Research Limitations/implications: The study's limitations must be recognized, notably the focus on India and the Medical Devices Policy 2023 context. Accordingly, the results hinge on India's "Make-in-India" policy and incentives for the medical devices sector, possibly not translating directly to countries with distinct policies or industrial priorities. With a sample size of 224 firms, sector diversity representation may be inadequate, potentially restricting the findings' generalizability. While offering insights into Indian challenges and opportunities, broader validation across diverse contexts and larger samples is essential to ensure the results' robustness and broader applicability beyond outlined circumstances.

Practical Implications: The model's insights hold crucial implications for policymakers in India's medical devices sector. Firstly, urgent attention is required to tackle identified challenges for sustainable export growth. Prioritizing initiatives to enhance sector knowledge and expertise through training programs and collaborations with experts is paramount. Moreover, streamlining regulatory barriers, including product registration and approval processes, are imperative for simplifying market entry. Additionally, addressing financial challenges by facilitating access to finance through tax incentives or funding schemes is essentially vital. Furthermore, learning from successful models in other countries like Costa Rica, South Korea, Germany and China can guide effective policy implementation in an Indian context. Correspondingly, the business firms should nurture a competitive domestic market through innovation support and stakeholder engagement for long-term growth.

Social Implications: For managers in India's medical devices sector, these implications are equally significant. Investing in knowledge and regulatory expertise is paramount to navigate complex landscapes effectively. Accordingly, there is a need to develop robust financial planning strategies, exploring diverse funding sources and tailoring products to meet local demands while aligning with global standards. Moreover, active engagement with policymakers is required for supportive policy reforms and similarly, collaboration with industry stakeholders can create a favourable operating environment. By addressing these implications collaboratively, policymakers and managers can overcome barriers, drive innovation and foster sustainable growth, positioning India as a global leader in medical device exports.

Originality/value: Narrating the results, this paper identifies the barriers that need to be factored into the Medical Devices Policy 2023. The paper sequentially explains how to nurture an enabling business ecosystem for export excellence in India's medical devices industry.