Regulatory review of new product innovation: Routine-practice perspective

Abstract

Regulatory agencies have come to represent non-market actors whose safety evaluations of products determine the market access and commercial success of new products. Yet, the extant discourse on regulatory agencies and their review of new product innovations (NPIs) has only offered an understanding of the phase-gate product review process, strategies used by innovating firms to navigate regulatory constraints, and a (re)conceptualization of the role of regulatory agencies as innovation intermediaries — all within stable and well-defined contexts. This has led to limited insights into the internal dynamics of regulatory activities and processes: specifically, their ongoing coping and adaptive responses to innovation landscapes, market conditions, and the organizing contingencies at the interface of socio-cultural and material contexts that establish their local rationale for conducting product reviews. Drawing on the contemporary turn to practice and routines in social theory as a lens, this thesis explores regulatory review of NPIs by examining how the local coping practices of product evaluators at the coalface of NPI evaluation coalesce to define the adaptive character of regulatory agencies and their responses to context-specific conditions that combine to form and shape regulatory review of NPI process. Developing the study’s contribution based on the organizing routines of a regulatory agency operating in a context marked by underdeveloped markets and institutions, the Ghana Food and Drug Agency (FDA) served as the empirical research site. Elucidating how practices and routines underpinning the review of NPIs cohere in the form of exaptive strategies to parry the disruptive and evolving innovation landscape, emphasis was placed on the product evaluators’ situated practices, dispositions, and organizing relations to theorise the product review process and adaptive tendencies of the agency. Adopting interpretive research approach and attuning to an exploratory research design, data for the empirical inquiry was chiefly collected through ethnographic semi-structured interviews with thirty-one (31) regulatory officers, supervisors and laboratory analysts working across four loosely coupled departments within the FDA. This was supplemented with three hundred and fifty (350) hours of non-participant observation, and twenty-five (25) publicly available data sources in the form of archival documents on the work of the regulatory agency. The main findings from the study are captured in threefold. First, in delineating how the regulatory review of NPIs may play out in practice in contexts marked by underdeveloped markets and institutions, the study identified salient interactive patterns of routines that are coded in artefactual materials to inform situated practices and skilled adaptive actions of product evaluators, which cumulatively constitute cognitive and noncognitive routines that give life to the regulatory review process. Second, a continuous (re)creation of established patterns of product evaluation yields a set of tacit knowledge and innovative practices that underline the adaptive qualities needed to both sustain the intention of the product evaluation framework and respond to the fluxing innovation landscape and contextual dynamics. Third, ongoing adjustments and navigation of sediment patterns of action that provide stable orders in the regulatory review process come to define the regulators’ sensitivity to local circumstances as a way-finder to achieve a responsive regulatory review framework. Four primary contributions emerge from the thesis. First, by examining the connections between structures and agency underpinning regulatory processes and decisions from a routines-practice perspective, the thesis offers theoretical specifications of how the mutually enabling bundles of codified stable patterns in the form of organizing structures, and the actual situated accomplishment of product evaluators, interact to co-constitutively define the shared organizing practices that portray what, and how, regulatory reviews are conducted. Second, explicating beyond the contents and sequence of aggregated patterns that define regulatory review processes, the thesis extends our understanding of regulatory reviews by unveiling how the situated enactment of regulatory evaluations possesses a great deal of socio-cultural contingency, such that the navigation of organizing boundaries to define new evaluation paths is construed in interactions within webs of competing and complementary logics, socio-cultural repertoires and persuasions, and a duality of stability and agility-seeking. Third, the thesis offers deeper insights into the dynamics of micro situated practices of the atomistic individual who engages in the day-to-day evaluation of new products, the interactive web of mutually enabling relationship between organizing structures, clusters of evaluation routines and their co-evolving patterns to define both stability and change in regulatory review processes. Fourth, contributing to the burgeoning discourse on the relational ties between innovating firms and regulatory agencies as a form of non-market strategy that yields competitive advantage, the thesis underlines the collaborative efforts between innovating firms and regulatory agencies as a pragmatic approach to developing expertise and narrowing the knowledge gaps that have long underpinned the enduring concerns about regulatory uncertainty.