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Regulatory authorities in developing economies not only face challenges regarding their own capabilities, but also have to grapple with heterogeneous levels of technological and innovation capabilities in firms. This paper draws from a firm-level analysis of internally created knowledge, externally sourced knowledge and firm heterogeneity among medical device manufacturers in South Africa to consider the corresponding evolution, development and deployment of regulatory capabilities in firms in their efforts to comply with the country’s health and allied products regulatory authority requirements. From this consideration, the paper explores possible broader adjustments in the country’s medical device sectoral system of innovation which would promote, nurture and embed the desired regulatory capabilities in firms to enable medical device firms to be locally and globally competitive and to contribute optimally to the country’s health sector objectives.

Some emerging countries have made significant progress in developing local pharmaceutical and biotechnology but had less success in building medical device industries. This paper explores the weak development of local medical device industries by analysing the contrasting evolutionary trajectories of Indian healthcare technology sectors. The Indian pharmaceutical and biotechnological industries have emerged as leading global suppliers of generic drugs and vaccines, in marked contrast to the medical devices industry. This paper reveals that weak collaborative linkage between medical device manufacturers and the Indian health system, largely absent systemic and cross-sectoral linkages, and weak communication between industry and government policy makers have become a huge barrier to the development of the Indian medical device industry in the contemporary neo-liberal environment. The weak connection between technology and industrial policy and healthcare policy objectives has severely hampered both development of national technological capabilities and the creation of affordable healthcare.

We use the concept of ‘imagined communities’, and related work on socio-technical imaginaries and expectations, to reflect on how Scotland is represented simultaneously as ‘sick and unhealthy’ and a ‘living lab’ due to its innovative medical research. Together, we suggest these narratives have driven a broader health and wealth agenda in post-devolution Scotland, which became salient during the 2014 independence referendum. We draw on research conducted during the independence referendum to consider how key stakeholders enacted imagined communities/identities (sick but also innovative) as they considered the historical impact of devolution on health and research systems and envisioned future independence. The referendum provided an opportunity to consider how Scottish health and research systems have been imagined over time. Our findings further the understanding of the impact of devolution on healthcare and medical research, revealing the role played by policy narratives rooted in imagined identities.

In this paper we investigate the implementation challenge of Smart Specialisation Strategies (S3) in catch-up regional environments, through the lens of capacity building. We analyse capacity building at two levels: micro-level (individual organisations) and meso-level (regional inter-organisational networks). We use empirical evidence from 50 interviews conducted in the period 2015-17 from two Greek regions dramatically hit by the economic crisis (Crete and Central Macedonia). We argue that in the Cretan and Central Macedonian context, the difficulty of implementing S3 is directly linked with firms’ lack of adsorptive capability to exploit university-generated knowledge, university knowledge that is too abstract for firm’s to easily acquire, as well as to the capability of regional actors to build inter-organisational networking that fits their strategic needs.

This article analyses important changes in technological innovation in the upstream petroleum industry. It provides evidence that shifts in sectoral patterns of innovation over the petroleum industry’s lifecycle from the 1970s up to 2005 were dependent on the dynamics of knowledge base complexity, a key dimension of an industry’s technological regime. Accordingly, observed shifts in innovation patterns are understood to be the aggregated strategic response of industry innovators to changes in the technological regime. The article proposes a quantitative method for exploring knowledge base complexity and Schumpeterian patterns of innovation, and interactions between the two at the industry level. As the industry evolved, its knowledge base moved to higher orders of complexity creating a shift in the Schumpeterian pattern of innovation. Increased knowledge base complexity was found to alter Schumpeterian patterns from Mark I towards a ‘modified’ Mark II. Instead of coming predominantly from ‘traditional’ established oil operators, technological innovation was increasingly triggered by a new class of emergent integrated service companies – ‘second tier’ systems integrators of the upstream sector able to cope with increased knowledge base complexity.

This article analyses important changes in technological innovation in the upstream petroleum industry. It provides evidence that shifts in sectoral patterns of innovation over the petroleum industry’s lifecycle from the 1970s up to 2005 were dependent on the dynamics of knowledge base complexity, a key dimension of an industry’s technological regime. Accordingly, observed shifts in innovation patterns are understood to be the aggregated strategic response of industry innovators to changes in the technological regime. The article proposes a quantitative method for exploring knowledge base complexity and Schumpeterian patterns of innovation, and interactions between the two at the industry level. As the industry evolved, its knowledge base moved to higher orders of complexity creating a shift in the Schumpeterian pattern of innovation. Increased knowledge base complexity was found to alter Schumpeterian patterns from Mark I towards a ‘modified’ Mark II. Instead of coming predominantly from ‘traditional’ established oil operators, technological innovation was increasingly triggered by a new class of emergent integrated service companies – ‘second tier’ systems integrators of the upstream sector able to cope with increased knowledge base complexity.

For the first time, the UK research evaluation system, known as the Research Excellence Framework, considered ‘measures’ of impact in the 2014 review. Here, we focus on impact case studies that had an engineering and international development orientation. We found that writers of impact case studies commonly chose to employ an ecological modernization (economic, environmental, and social value) discourse to shape value claims. We also found that the type of engineering and international development research that appears in impact case studies tends to be high tech, best-with-best, and exclusive, rather than low tech, humanitarian, and inclusive.

The decades since the 1950s have witnessed major growth in the bioeconomy. Emergence of the bioeconomy as a broad, creative and rapidly expanding part of the global economy coincides with the maturation of the established drug discovery system. This paper presents research evidence focused on the relationships between changes in the bioeconomy and changes in the global economy. It argues that new forms of governance and regulation are key to strengthen industrial policies needed for emerging and developing countries to take account of the complex interactions in life science innovation between technology, markets, regulation and civil society, which could significantly impact on global distribution of the industry.

This paper is intended to understand the evolution of the Scottish science and innovations systems before the Scottish independence referendum of September 2014, and the prospects for the next years. Scotland traditionally has a strong science base, with world-leading universities driving the development of science, together with a diverse range of associated research institutes, which mostly survived the Thatcher government rationalisation and privatisation of public research institutes. The science system has been strengthened during the 2000s as devolution brought a set of new and expanded funding streams into the existing UK-based institutions.There are questions, however, about the relationship between the science base and Scotland’s innovation system. Although it is neither possible or healthy to attempt to rigidly glue science priorities directly to local innovation dynamics, it is important to analyse the frameworks, policies and relationships between actors and activities to understand how Scottish scientific excellence can be exploited to improve capacities for social, cultural and economic development.This paper first traces key elements of the historical development of the Scottish science system, and the relationship between science and innovation. Then, it details the present situation regarding Scotland’s science base, mapping the Scottish institutions that exist to integrate Scottish science policy. It shows that the science system already operates with some, though rather limited, autonomy from the rest of the UK. This is followed by an analysis of the rather tenuous level of connection between science and innovation. Finally, it presents some thoughts on the future prospects for science and innovation post-referendum.

This paper is driven by two key questions. First, what does a fully devolved healthcare system and partially devolved medical and clinical research system mean in practice, and what have been the social, economic and clinical challenges and opportunities engendered by devolution? Here, we want to identify and better understand the key institutional assets and unique selling points in Scotland that have been used to drive a particular health and wealth policy agenda. Second, what do different professionals and key stakeholders (academic researchers, NHS directors, research funders and commercial organisations) see as the potential benefits of full independence or further devolution, and what do they feel may be lost for clinical and medical research, society, economy and public health?A key message from our work in this area is that the Scottish healthcare system and the clinical and medical research systems are very much interdependent, and the complex institutional ecology that has evolved since devolution will have a significant impact on how the benefits and limitations of independence will be realised and distributed. So far the debate about independence has focused very much on health and social care, but the Scottish system and its quality depends hugely on its medical and clinical research base. This paper addresses this important part of the independence debate.This Working Paper is one in a series as part of Innogen’s work with the ESRC Future of the UK and Scotland programme.

The road to the independence referendum may have begun with devolution in the late 1990s, but a key question is: what have been the impacts on health and clinical research since the process of devolution was initiated? The impact of devolution on key areas of life, such as health and medical research is undoubtedly important. Building high quality medical research infrastructure in Scotland and retaining healthcare and research expertise is a priority in terms of improving understanding of the aetiology of disease and diagnosing and developing therapeutic treatments to benefit the Scottish population. In some cases, the research drive might include pharmaceutical companies investing and/or collaborating with Scottish facilities to bring both health and wealth benefits to Scotland.This paper identifies and interrogates the change of narratives, relevant to the health debate under devolution, which frames discussions around potential Scottish independence. Pre-devolution there is a strong sense of Scotland as having unique health problems and hence, the ‘sick man of Europe’ label, which required policy responses from the devolved government and the new powers it acquired. Under devolution, this engendered a second narrative built around the ‘living lab’ concept. So here, we see a significant change in narrative emphasis from the pejorative Scotland as the ‘sick man of Europe’ to a more positive rhetoric about the many opportunities for clinical research that emerge from a sick population and could attract inward investment to a devolved Scotland.This Working Paper is one in a series as part of Innogen’s work with the ESRC Future of the UK and Scotland programme.

Agricultural biotechnology is typically analyzed critically by means of a political ecological focus on the science and its ecological implications - agbio science as a radical, and 'non-natural', break with 'normal' trajectories for 'new plant science'. Surprisingly, less attention has been paid to a range of key political economic issues, many of which were important in the last big food production technology 'revolution', the Green Revolution. This paper will focus on three areas of political economy. First, we discuss the corporate drivers of agricultural biotechnology, and examine whether these drivers have already set the technology so that it cannot be changed. Second, we investigate the present economics and technology of genetic modification in plants, and its possible future. Third, we examine empirical evidence for alternative visions of the technology.

Science, technology and innovation (STI) are crucial to economic and social development. The use, adaptation and creation of health technologies and innovation are fundamental to Africa’s ability to deliver better health care to its people. However, simply importing new technologies is not a solution for building the expertise and capacity needed to put science and technology to productive use and make them work in the interests of developing country populations. Using examples of how India, Cuba, China, Brazil and South Africa have endeavoured to harness health innovations, this paper argues that improving immediate access to health care and health technologies is essential but not sufficient for sustainable health improvement and poverty alleviation, unless it is done in a holistic and sustainable manner linking existing challenges, priorities and capacities. A health innovation systems perspective can help in attaining this balance.

This thesis examines public policy implementation in catch-up regions through the analytical lens of Smart Specialisation Strategies (S3). Smart specialisation is a regional innovation strategy, introduced in 2010 as the main European cohesion policy to promote economic convergence. Empirical research shows that catch-up regions encounter major difficulties in putting S3 theory into practice. The need to understand why S3 development cannot be taken for granted, brings into focus the implementation challenge of smart specialisation, which is currently associated with weaknesses in building responsive governance models, thick institutions and strong research capabilities for innovation-driven growth. This study investigates S3 challenges in two European catch-up regions: Crete and Central Macedonia. It builds upon a conceptual framework that brings together elements from regional innovation studies with institutional and capacity building theories, aiming to investigate public policy implementation barriers in two Greek regions which have been in fiscal crisis for over a decade. It suggests that S3 barriers derive from a much wider knowledge gap in regional studies, already existing before the introduction of smart specialisation as a development strategy. This gap rests on the lack of empirical understanding of what governance and institutional change is required in lagging regions to tackle the regional innovation paradox: how change impacts on economic growth, when change must be initiated to be feasible and realistic, and what capabilities are needed to support change for regional renewal and development. To operate the conceptual framework, a qualitative case study approach has been designed, using evidence from academic, public and private local actors with a key role in developing S3. Primary data were collected by means of fifty semstructured interviews; participant observation was also used as a complementary method. Secondary data were gathered from a detailed documentary analysis of official textual sources. The thesis demonstrates the implementation challenge of smart specialisation, extending previous studies which examine S3 development in lagging regions. In contrast to much literature, it shows that S3 barriers are not simply due to weakness of catch-up regions to build research capacities, but also to non-smart specialisation-related barriers, yet highly influential on policy implementation. Such barriers include critical mass accumulation problems, public-sector administrative burden and lack of public-private trust. They are institutional and capacity building-related, and they should not been seen, in conceptual terms, as a precondition to effective S3 implementation. Rather, they are the result of a concurrent existence of weak policy governance models, limited institutional autonomy for regional self-governance and lack of transformative capacities for structural shifts. Two contributions to knowledge are made. Firstly, the research contributes to bottom-up theoretical understanding of regional policy development by showing that S3 debate should no longer be just about improving research capacities, but about how to best understand and address opportunities and challenges emerging from bringing together institutional integration, policy governance advances and capacity building improvements. Particularly, it evidences that S3 challenge needs to be examined and understood through a concurrent analysis of the ways in which governance, institutions and capabilities embedded in the wider environment of a region are related and evolved. Secondly, it contributes to the further advancement of regional studies, by providing a practical understanding of how to best develop S3 in practice. A three-stage policy implementation model is developed to support innovation strategists to search for an S3 implementation mix that best corresponds to their own needs.

This thesis presents findings from a qualitative enquiry into the rapid uptake of the mobile phone by pastoral communities in Tanzania and its use as a tool to tackle marketing constraints. The research design involves an interregional comparative analysis of two key production regions: Arusha and the Lake Zone, and two groups of livestock producers (the Maasai pastoralists and Wasukuma agro-pastoralists respectively). Applying the Social Shaping of Technology (SST) perspective from Science and Technology Studies (STS), and in particular the concept of ‘appropriation’, the study examines the embrace of mobile phones by those producers – who keep livestock under the extensive (pastoralist) and semi-intensive (agro-pastoralist) systems respectively. The thesis examines the extent to which the mobile phone is changing how livestock keepers interact in the livestock market and how this is affecting their livelihoods. The thesis shows that the significance of the mobile phone varies with user groups; for instance, for the Maasai who still lead a nomadic life, the mobile phone is used ‘conservatively’ to communicate about herd management and to coordinate household affairs in ways that do not substantially disrupt traditional social practices and roles. In contrast, the Wasukuma agro-pastoralists use mobile phones to introduce new processes to support production and marketing, one good example being the strategy used to coordinate transportation of cattle to market. The study findings suggest the extension of the “appropriation” (Williams, Stewart, & Slack, 2005) conceptualisation by adding the possibility of a spectrum from shallow to extended according to users’ role and the context of use. Nevertheless, and in more generic terms, it is possible to say that the mobile phone use did not disrupt some of the traditional practices and trade customs amongst the Maasai, and it has reinforced the innovative behaviour of the Wasukuma. The thesis also examines a parallel initiative whereby aid agencies and public bodies in Tanzania supported the development of the Livestock Information Network and Knowledge System (LINKS), as an ICT platform designed to improve the livestock market by sharing market information. However, studies show that LINKS has not had the intended effect, is not trusted and has not been adopted by many pastoralists. The study shows how the concept of trust, which is key in market dynamics and trade relations, has been reshaped, because the mobile phone has supported informal communications that reinforce traditional methods of policing trust in the market. The thesis contributes to ongoing debates surrounding the conceptualisation of Information and Communication Technologies for Development (ICT4D). The failure of early ICT4D initiatives was attributed to a failure to address users’ specific requirements, due to gaps in the translation process, as well as to socio-political and technical fragilities such as the lack of adequate infrastructure, and a deficient social learning process. The initial reworking of ICT4D highlighted the need to design technology as a specific solution appropriate to particular contexts/user groups. These were seen as finished solutions (corresponding to the idea of a ‘technical fix’). Focusing upon ‘appropriation’, in line with the Social Shaping of Technology – Mark 2 approach – allows scope for a further rethinking of ICT4D which addresses not just design but the active role of users in shaping technological innovation to the context and purposes of communities in developing countries.

This thesis is an in-depth case study of an interdisciplinary, paradigm breaking, research team who are seeking to develop cultured red blood cells (RBCs) for transfusion using stem cells (known as the BloodPharma project). It answers the research question: What can an in-depth case study of the BloodPharma project reveal about everyday scientific practice and the project management of a large research programme? The BloodPharma project occupies a unique position within the stem cell arena due to the size and multi-disciplinary nature of the project team, and the unique risk profile of cultured RBCs. The historical significance of blood donation is combined with the modern innovation of stem cell usage, to create a product which is both novel but also highly emotive. The case study comprises interviews with a range of stakeholders, laboratory observation, and participant observation of public outreach activities. In addition presence at team meetings and teleconferences has allowed an in-depth analysis of the project progression. The thesis has also drawn heavily on science and technology studies and scientific literature, as well as on information gathered from a wide variety of conferences and workshops. Key findings indicate that early stage laboratory work in this interdisciplinary project is achieved through the standardisation of work across different research spaces, with training and visual aids used to overcome the hurdle of tacit knowledge associated with the development of stem cell technologies. In designing early stage laboratory work the team looked to the human body as a benchmark of in vivo RBC production, using in vivo cells as a dual standard for which the team must aim, but cannot fall short of. Scale-up and standardisation were identified as the key challenges to the translation of this early stage laboratory work into a clinically useable product. These challenges require new expertise and innovation, and are an example of the translational obstacles of tacit knowledge and visual techniques which are found in the wider stem cell field. The use of target markets was identified by the team as a stepping stone to larger scale production, although in common with other stem cell therapies the clinical trials route to first-in-human use is still unclear. The uncertainty of regulation for stem cell products, and specifically how this relates to the BloodPharma project, is also a key finding of this thesis. Interactions with the regulatory system are seen as a necessity but also represent an area of confusion for laboratory researchers, requiring much specialist knowledge to understand and navigate regulatory documents. Regulatory expertise is brought to the BloodPharma project through reliance on particular members of staff. Public outreach has formed an important part of the BloodPharma project and shows the scientists stepping outside their primary area of expertise, a reflection of the broader trend amongst academic research to demonstrate ‘broader impact criteria’. Public outreach for the BloodPharma team was found to occupy a unique niche, given that the team must balance the promotion of a future product with the preservation of the current donation system. This research is of a case study which goes beyond the boundaries of the laboratory, to look not only at early stage laboratory work, but also at the way in which the team envisions future translation and regulatory hurdles, and the public outreach which must combine to develop a novel stem cell therapy. The thesis is the first in-depth case study to follow a large, interdisciplinary, stem cell team through the work they carry out both within the laboratory space, and outside it; challenging the idea of what it means to carry out scientific work in this novel area of stem cell therapies.

According to conventional wisdom, the petroleum industry is classified as a ‘resource based’ and ‘mature’ industry. It is subject to the ‘resource curse’ thesis, exhausted of ‘technological opportunities’ with limited capacity for knowledge based economic growth. This study questions the adequacy of this line of reasoning. Exploring the technological complexity of the sector, a complementary argument is presented. We show that the sector has recently experienced a surge in ‘technological opportunities’. However the ‘systemic complexity of the knowledge base’ has constrained many oil producing countries’ enjoyment of these opportunities. This view highlights the role of dynamics of knowledge base complexity as an important ‘cognitive’ barrier for building innovation capabilities in endowed countries. This study is based on the extension of a ‘Sectoral Innovation Systems’ approach, highlighting the role of technological regimes in catch-up possibilities and strategies. Knowledge base complexity is explored as an under-researched element of technological regimes. The research contributes in three ways. First, it introduces a dynamic and three-dimensional view of knowledge base complexity at the conceptual level, and hypothesizes its implication for patterns of innovation and catch-up processes. Second, a quantitative methodology is developed to examine the proposed hypotheses. Third, the conceptual and methodological suggestions are empirically examined in the context of upstream petroleum industry. The findings propose that the sector has gone through phases of transformation and reconfiguration. The sector’s technological regime over the most recent period experienced high opportunities combined with rising systemic complexity of the knowledge base. We show that this trend in technological regimes is associated with shift of the sector from Schumpeter Mark I to II and with the emergence of major Integrated Service Companies as new system integrators coping with rising systemic complexity. We also observe that rising systemic complexity is associated with slow down and halt of geographical dispersion of innovation. The sector-wide cumulativeness stemming from systemic complexity creates high cognitive barriers to entry for latecomers. The very scarce examples of catch-up in a few advanced oil producing countries suggest that high innovation opportunities in complex industries are open mostly to countries with both advanced national innovation systems and accumulated production experience. For latecomer countries to benefit, their industrial policy needs to cope with increasing systemic complexity, mitigating its coordination costs and facilitating the integration of distributed catch-up processes. This highlights the key role of ‘late comer systems integrators’ for successful catch-up.