Conference Agenda

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Session Overview
Session
SAT 3-1: Health and Finance
Time:
Saturday, 06/Dec/2025:
8:30am - 9:25am


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Presentations

Diffused Errors along Technology Spillovers: Evidence from the 510(k) Medical Device Market

Po-Hsuan Hsu1, Kyungran Lee2, S. Katie Moon3, Seungjoon Oh4

1National Tsing Hua University; 2Neoma Business School; 3University of Colorado; 4Peking University

We examine the diffusion and consequences of technical errors through spillovers using the predicate list in the 510(k) program in which a new device is proved substantially equivalent to existing ones (i.e., predicates). We match a recalled device with its unrecalled “sibling” and find that the follow-on devices being equivalent to a recalled device are more likely to be recalled (and have more adverse events), especially when the former’s manufacturers are more likely to copy technical errors from the recalled device. Such diffused errors negatively influence recalled device manufacturers’ growth while providing competitors with opportunities for market shares and inventions.