Understanding Ecosystems through Insights from Standardisation Research: A Discussion Contribution Based on Preliminary Insights from the Case of In-Vitro Diagnostics

Ecosystems consist of a number of self-interested parties that jointly create value. In order to create this value, ecosystem members need to create alignment. This alignment structure does not only determine how the ecosystem creates value, but also who can capture this value and who can wield influence over the ecosystem. Despite alignment being core for ecosystems, literature provides few insights into how it comes about. This paper takes the standardisation literature as a starting point to study this process. It provides preliminary insights from a case study of the European In-Vitro Diagnostics Ecosystem, which currently faces new regulation that challenges the ecosystem’s existing alignment structure. These preliminary insights point towards standardisation being a key to achieving alignment, and open up perspectives for further research.