Abstract
This short critique aims to share the evolving regulatory environment and compliance challenges that innovators, nanotechnologists, and public health enthusiasts in India ought to keep in mind before hopping on the bandwagon of innovative point-of-care diagnostic devices in the primary healthcare space. More significantly, the priority-setting approach suggested by the authors needs to be adapted through iterative practice and refinement in order to identify innovative point-of-care diagnostic devices that can eventually raise the quality and cost-effectiveness of healthcare provisions at the last-mile.
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