Decentralized manufacturing and institutional readiness: adoption as a distributed process
Cell & Gene Therapy Insights 2019; 5(10), 1061-1067.
The model of decentralized manufacture is said to offer a new approach for more effective translation of cell and gene therapies to the clinic (and indeed in other sectors). Much of this depends on ensuring that key processes such as scalability and traceability are well-understood and properly managed as products move through to the clinic. The adoption of these therapies will require the creation of a novel trans-organizational innovation space. The latter can be better understood through deploying the social science model of institutional readiness to focus attention on the specific capacities that are needed to create not merely working but workable therapies, those that make sense in the clinical environment. This article outlines the model of institutional readiness, comparing it with the linear and primarily technically-based model of ‘technology readiness levels’, showing how it can help anticipate the specific capacities needed to build a new (decentralized) innovation space.