Innovators of medical devices often face overlapping phases marked by insufficient funding, regulatory complexities, and underdeveloped infrastructures. These overlapping phases are commonly referred to as “Valleys of Death.” To navigate these hurdles, this article presents a matrix-based decision-support tool, integrating known innovation bottlenecks, stakeholder roles, and infrastructure needs across the nine technology readiness levels. By mapping key undesired effects and their corresponding alleviations onto a structured matrix, innovators can identify strategic interventions well before severe project failures occur. Using the event history analysis method and South Africa’s National Ventilator Project as a case study, the article demonstrates how this tool provides insight into potential resource misalignment, regulatory delays, and stakeholder disengagement. The framework’s flexibility makes it a valuable guide for managing medical device projects across different healthcare settings.
Entrepreneurship and Innovation
Bridging Multiple Valleys of Death in Medical Device Innovation: A Matrix-Based Decision-Support Framework
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