Strategic Model for Strengthening National Medical Device Industry Self-Sufficiency: A Mixed Methods Approach Based on Performance Indicators and Pentahelix Collaboration

The self-sufficiency of the medical device industry is a fundamental pillar in strengthening national health resilience, particularly in the post-COVID-19 context. However, structural challenges—such as fragmented cross-sector policies, import dependency, and weak inter-actor collaboration—remain key obstacles. This study proposes a strategic roadmap model to accelerate industrial self-reliance through a sequential exploratory mixed methods approach, beginning with qualitative exploration followed by quantitative analysis. Qualitative data were collected through 24 Focus Group Discussions (FGDs) involving pentahelix actors (academia, industry, government, community, and media) between 2021 and 2023, reinforced by the 2021 National Medical Device Industry Survey covering 148 firms from a population of 487. Structural validation was performed using a purposive sample of 32 key stakeholders, including representatives from ministries, industry associations, academia, and policymakers. Thematic analysis and grounded theory were used to extract qualitative insights. Meanwhile, quantitative data from the stakeholder survey were analyzed using Partial Least Squares - Structural Equation Modeling (PLS-SEM) with SmartPLS 3.2.6. The study identified six strategic dimensions that significantly influence industrial self-sufficiency: (1) regulatory and policy strengthening, (2) ecosystem visibility and transparency, (3) customer-oriented focus, (4) pentahelix collaboration, (5) supply chain agility, and (6) sustainability. The SEM model confirmed the statistical significance of these dimensions, with sustainability emerging as the most dominant predictor. Qualitative findings further emphasize the importance of cross-sector policy alignment, integration of research into production processes, and the provision of innovation-based local incentives.