Regulatory review of new product innovation: Routine-practice perspective

This thesis was submitted for the award of Doctor of Philosophy and was awarded by Brunel University LondonRegulatory 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.Ghana Scholarships Secretaria

On the consequences of AI bias: when moral values supersede algorithm bias

Purpose – This study responded to calls to investigate the behavioural and social antecedents that produce a highly positive response to AI bias in a constrained region, which is characterised by a high share of people with minimal buying power, growing but untapped market opportunities and a high number of related businesses operating in an unregulated market. Design/methodology/approach – Drawing on empirical data from 225 human resource managers from Ghana, data were sourced from senior human resource managers across industries such as banking, insurance, media, telecommunication, oil and gas and manufacturing. Data were analysed using a fussy set qualitative comparative analysis (fsQCA). Findings – The results indicated that managers who regarded their response to AI bias as a personal moral duty felt a strong sense of guilt towards the unintended consequences of AI logic and reasoning. Therefore, managers who perceived the processes that guide AI algorithms’ reasoning as discriminating showed a high propensity to address this prejudicial outcome. Practical implications – As awareness of consequences has to go hand in hand with an ascription of responsibility; organisational heads have to build the capacity of their HR managers to recognise the importance of taking personal responsibility for artificial intelligence algorithm bias because, by failing to nurture the appropriate attitude to reinforce personal norm among managers, no immediate action will be taken. Originality/value – By integrating the social identity theory, norm activation theory and justice theory, the study improves our understanding of how a collective organisational identity, perception of justice and personal values reinforce a positive reactive response towards AI bias outcomes

(Re)envisioning the role of technology transfer intermediaries in socio-technical transition

Recent year has seen a rise scholarly interest in examining the functions and value of technology transfer intermediaries (TTIs) in spurring and commercializing sustainable innovations. In this paper, we embark on a conceptual endeavor that explores existing research on TTIs to identify their various roles, structure, networks and practices that define their organizing patterns and schemas. We adopt an envisioning approach to reconceptualize the role of TTIs in sustainable transition and go on to reconceive the core insights from the extant literature to inform ways to facilitating a global socio-technical transition agenda. This attempt thus set forth a system that captures a global TTI market for the exchange of technological capabilities across regions. Our study contributes to discourses at the intersection of international technology transfer intermediaries and sustainability transition

The Airbus bribery scandal: A collective myopia perspective

Drawing on collective myopia as a lens, we explore the infamous Airbus bribery scandal to show how the executives of the global aircraft manufacturer, through their actions and behaviours, institutionalised the payment of bribes to secure contracts. Data for the inquiry consist of publicly available court-approved documents, company website and internal emails, and newspaper articles on the scandal. Unpacking the bribery scheme operated by Airbus, we found that bribing of foreign government officials and airline executives to secure contracts was part and parcel of the firm's organising strategy. In this regard, the organising practices of Airbus actively encouraged employees to break its own bribery compliance policies which they employed as smokescreens to cover their illegal activities. Building on our findings, we developed a collective myopic-bribery framework outlining how the collective myopia in organising drove the bribery activities at Airbus. The implications of the findings for theory and practice are outlined

In Defence of the Indefensible: Exploring Justification Narratives of Corporate Elites Accused of Corruption

Drawing on the pragmatic turn in contemporary social theory, we explore how corporate elites accused of corruption in the context of weak institutions engage in their justifcation works. Empirically, we focus on three high-profle corruption scandals that shook Ghana between 2010 and 2020 and inspired widespread public condemnation. Publicly accessible archival documents, such as court reporting, newspaper stories, press conferences, and the digital footprints of corporate elites implicated in the scandals provide data for our inquiry. Focussing on the juxtaposition of ‘sayings’ and ‘doings’, the fndings show justifcation as performative, and rooted in contextual pragmatism that acknowledges the plurality of logics situated between self-interest and folk-logic. Within this framework, the domestic and civic orders of worth emerge as most prominent, with the justifcation processes manifesting through victimising, scapegoating, and crusading. Building on these insights, we develop a framework that highlights how the use of justifcations serves as a critique of the inadequacies within climates of weak institutional frameworks consequently fostering an atmosphere conducive to framing unethical conducts as morally acceptable

The three pointers of research and development (R&D) for growth-boosting sustainable innovation system

Research and development (R&D) is frequently touted and labelled as the fundamental engine for creating sustainable innovations and achieving climate transitions. Yet, recent R&D efforts have struggled to live up to the widespread life-altering results they delivered in the 1960s when the term R&D was coined. In our attempt to address this concern, we propose a sustainability pathway model to achieving an economically viable innovation system that is anchored in three important pointers of R&D which have long been viewed as mutually distinct components in R&D budgets—investment, talent, and learning institutions. Directing attention to the pervasive need to align R&D investments with talents and learning institutions, we delineate how these pointers of R&D coming together to constitute a trivalent force may drive a growth-boosting sustainable innovation system. While there is no simple recipe which suggests an optimal combination of new scientific understanding, technologies, and process that could help produce the much-needed innovations and technological change, we present a set of propositions that highlights opportunities for reflection on existing R&D investment strategies and serves as a bridge to connect the emergent scholarship on sustainability with the intellectual traditions of R&D in innovation management

A meaning-making perspective on digital ridesharing platforms in underdeveloped markets

Purpose: The digital platform-based sharing economy has become ubiquitous all over the world. In this paper, we explore how market actors’ conflicting interpretations of digital platforms’ business models give form and shape value co-creation and capture practices in contexts marked by weak institutions and underdeveloped markets. Design/methodology/approach: Integrating insights from the broader literature on digital platforms and the contemporary turn to “meaning-making” in social theory, we adopt a problematization method to unpack the collective contest over the interpretation of value co-creation and capture from ridesharing platforms in contexts marked by weak institutions and underdeveloped markets. Findings: Collective contest over the interpretation of digital business models may give rise to competing meanings that may enable (or impede) digital platform providers’ ability to co-create and capture value. We present an integrative framework that delineates how firms caught up in such collective contests in contexts marked by weak institutions and underdeveloped markets may utilise such conditions as marketing resources to reset their organising logic in ways that reconcile the conflicting perspectives. Practical implications: The paper presents propositions constituting a contribution to a meaning-making perspective on ridesharing digital platforms by offering insights into how digital business models could potentially be localised and adapted to address and align with the peculiarities of contexts. It goes further to present a theoretical model to extend our understanding of the different sources of contestation of meaning of digital platforms. Originality/value: The meaning-making perspective on digital platforms extends our understanding of how the collective contest over interpretations of value co-creation and capture may offer a set of contradictory frames that yield possibilities for ridesharing platform providers, and their users, to assimilate the organising logic of digital business models into new categories of understanding

How managers ‘make meaning’ of business tournament rituals

In this paper, we examine how managers ‘make meaning’ of business tournament rituals (BTRs)— recognition-based contests in which participating firms get social endorsements and winners receive prestigious awards. In exploring two UK BTRs, we found that managerial orienting systems, made up of beliefs about the identity of their firm, competitors, and customers, and what it takes to compete in their environments, drive managers to compete in BTRs. Their interpretive view of BTRs as sources of strategic capabilities and hard market power, we argue, is constructed, and projected to the viewing public through a set of four distinct but ‘durationally indivisible’temporal frames: validating identity and values, competence signalling, product/service differentiation,and market and industry visibility; these may operate in combination or serially account for the observed managerial preoccupation with BTRs. We discuss the implications of our findings for theory, practice, and future research

How managers ‘make meaning’ of business tournament rituals

In this paper, we examine how managers ‘make meaning’ of business tournament rituals (BTRs)— recognition-based contests in which participating firms get social endorsements and winners receive prestigious awards. In exploring two UK BTRs, we found that managerial orienting systems, made up of beliefs about the identity of their firm, competitors, and customers, and what it takes to compete in their environments, drive managers to compete in BTRs. Their interpretive view of BTRs as sources of strategic capabilities and hard market power, we argue, is constructed, and projected to the viewing public through a set of four distinct but ‘durationally indivisible’temporal frames: validating identity and values, competence signalling, product/service differentiation,and market and industry visibility; these may operate in combination or serially account for the observed managerial preoccupation with BTRs. We discuss the implications of our findings for theory, practice, and future research

Global burden and strength of evidence for 88 risk factors in 204 countries and 811 subnational locations, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021

Background: Understanding the health consequences associated with exposure to risk factors is necessary to inform public health policy and practice. To systematically quantify the contributions of risk factor exposures to specific health outcomes, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021 aims to provide comprehensive estimates of exposure levels, relative health risks, and attributable burden of disease for 88 risk factors in 204 countries and territories and 811 subnational locations, from 1990 to 2021. Methods: The GBD 2021 risk factor analysis used data from 54 561 total distinct sources to produce epidemiological estimates for 88 risk factors and their associated health outcomes for a total of 631 risk–outcome pairs. Pairs were included on the basis of data-driven determination of a risk–outcome association. Age-sex-location-year-specific estimates were generated at global, regional, and national levels. Our approach followed the comparative risk assessment framework predicated on a causal web of hierarchically organised, potentially combinative, modifiable risks. Relative risks (RRs) of a given outcome occurring as a function of risk factor exposure were estimated separately for each risk–outcome pair, and summary exposure values (SEVs), representing risk-weighted exposure prevalence, and theoretical minimum risk exposure levels (TMRELs) were estimated for each risk factor. These estimates were used to calculate the population attributable fraction (PAF; ie, the proportional change in health risk that would occur if exposure to a risk factor were reduced to the TMREL). The product of PAFs and disease burden associated with a given outcome, measured in disability-adjusted life-years (DALYs), yielded measures of attributable burden (ie, the proportion of total disease burden attributable to a particular risk factor or combination of risk factors). Adjustments for mediation were applied to account for relationships involving risk factors that act indirectly on outcomes via intermediate risks. Attributable burden estimates were stratified by Socio-demographic Index (SDI) quintile and presented as counts, age-standardised rates, and rankings. To complement estimates of RR and attributable burden, newly developed burden of proof risk function (BPRF) methods were applied to yield supplementary, conservative interpretations of risk–outcome associations based on the consistency of underlying evidence, accounting for unexplained heterogeneity between input data from different studies. Estimates reported represent the mean value across 500 draws from the estimate's distribution, with 95% uncertainty intervals (UIs) calculated as the 2·5th and 97·5th percentile values across the draws. Findings: Among the specific risk factors analysed for this study, particulate matter air pollution was the leading contributor to the global disease burden in 2021, contributing 8·0% (95% UI 6·7–9·4) of total DALYs, followed by high systolic blood pressure (SBP; 7·8% [6·4–9·2]), smoking (5·7% [4·7–6·8]), low birthweight and short gestation (5·6% [4·8–6·3]), and high fasting plasma glucose (FPG; 5·4% [4·8–6·0]). For younger demographics (ie, those aged 0–4 years and 5–14 years), risks such as low birthweight and short gestation and unsafe water, sanitation, and handwashing (WaSH) were among the leading risk factors, while for older age groups, metabolic risks such as high SBP, high body-mass index (BMI), high FPG, and high LDL cholesterol had a greater impact. From 2000 to 2021, there was an observable shift in global health challenges, marked by a decline in the number of all-age DALYs broadly attributable to behavioural risks (decrease of 20·7% [13·9–27·7]) and environmental and occupational risks (decrease of 22·0% [15·5–28·8]), coupled with a 49·4% (42·3–56·9) increase in DALYs attributable to metabolic risks, all reflecting ageing populations and changing lifestyles on a global scale. Age-standardised global DALY rates attributable to high BMI and high FPG rose considerably (15·7% [9·9–21·7] for high BMI and 7·9% [3·3–12·9] for high FPG) over this period, with exposure to these risks increasing annually at rates of 1·8% (1·6–1·9) for high BMI and 1·3% (1·1–1·5) for high FPG. By contrast, the global risk-attributable burden and exposure to many other risk factors declined, notably for risks such as child growth failure and unsafe water source, with age-standardised attributable DALYs decreasing by 71·5% (64·4–78·8) for child growth failure and 66·3% (60·2–72·0) for unsafe water source. We separated risk factors into three groups according to trajectory over time: those with a decreasing attributable burden, due largely to declining risk exposure (eg, diet high in trans-fat and household air pollution) but also to proportionally smaller child and youth populations (eg, child and maternal malnutrition); those for which the burden increased moderately in spite of declining risk exposure, due largely to population ageing (eg, smoking); and those for which the burden increased considerably due to both increasing risk exposure and population ageing (eg, ambient particulate matter air pollution, high BMI, high FPG, and high SBP). Interpretation: Substantial progress has been made in reducing the global disease burden attributable to a range of risk factors, particularly those related to maternal and child health, WaSH, and household air pollution. Maintaining efforts to minimise the impact of these risk factors, especially in low SDI locations, is necessary to sustain progress. Successes in moderating the smoking-related burden by reducing risk exposure highlight the need to advance policies that reduce exposure to other leading risk factors such as ambient particulate matter air pollution and high SBP. Troubling increases in high FPG, high BMI, and other risk factors related to obesity and metabolic syndrome indicate an urgent need to identify and implement interventions