The inertia of a use regime. Why a celiac disease pill is conceived but not embraced?

The failure to involve users in research and development (R&D) processes continues to be a major reason for unsuccessful R&D. This failure can be understood by focusing on regimes (comprising heuristics, rules and routines) that orient and coordinate the activities of actors with regard to innovations. We describe the case of a pill for celiac disease patients and show that the conception and development of the pill was shaped by a technological regime that provides R&D actors with rules to routinely acquire relevant information about users and the market. Reserved patient organisations did not play a role. To understand the reserved reception of the pill, we elaborate the concept of a use regime. The reservations are understood as an expression of an existing diet-based use regime that guides the way the target group of the pill is currently dealing with celiac disease. The lack of interaction between the R&D actors in the consortium and the patient organisation appears to be a manifestation of the lack of alignment between the technological and use regimes. Based the regime literature, finally, three scenarios for the future development of the pill are discussed.