Health Product Manufacturers and Innovators COVID-19 Impact Assessment: Lessons Learned and Compelling Needs

United States health care spending consumes nearly a fifth of the GDP [1]. While, in many respects, the U.S. health care system is enviable and highly innovative, it is also characterized by elements of ineffectiveness, inefficiency, and inequity. These aspects, resulting from pre-existing vulnerabilities within the system and interactions between the various stakeholders, were acutely highlighted by the COVID-19 pandemic. As health product manufacturers and innovators (HPMI) took steps to mitigate the immediate crisis and simultaneously begin to develop a longer-term sustainable solution, six common themes arose as areas for transformational change: support for science, data sharing, supply chain resiliency, stockpiling, and surge capacity, regulatory and reimbursement clarity and flexibility, public- and private-sector coordination and communication, and minimizing substandard care offerings. Within these categories, the authors of this paper suggest policy priorities to increase the effectiveness, efficiency, and equity of the HPMI sector and writ large across the U.S. health care system. These priorities call for increased scientific funding to diversify the pipeline for research and development, strengthening the nation’s public health infrastructure, building and maintaining “ever warm” manufacturing capacity and related stockpiles, instituting efficient and effective regulatory and reimbursement frameworks that promote innovation and creativity, devising structures and processes that enable more efficient collaboration and more effective communication to the public, and implementing rewards that incentivize desired behaviors among stakeholders. This assessment draws from the collective experience of the authors to provide a perspective for the diagnostics, hospital supplies and equipment, medical devices, therapeutics, and vaccines segments. While the authors of this paper agree on a common set of key policies, sub-sector-specific nuances are important to consider when putting any action priority into effect. With thoughtful implementation, these policies will enable a quicker, more robust response to future pandemics and enhance the overall performance of the U.S. health care system.

Transformational Change in maternity services in England: a longitudinal qualitative study of a national transformation programme ‘Early Adopter’

Background Large system transformation in health systems is designed to improve quality, outcomes and efficiency. Using empirical data from a longitudinal study of national policy-driven transformation of maternity services in England, we explore the utility of theory-based rules regarding ‘what works’ in large system transformation. Methods A longitudinal, qualitative case study was undertaken in a large diverse urban setting involving multiple hospital trusts, local authorities and other key stakeholders. Data was gathered using interviews, focus groups, non-participant observation, and a review of key documents in three phases between 2017 and 2019. The transcripts of the individual and focus group interviews were analysed thematically, using a combined inductive and deductive approach drawing on simple rules for large system transformation derived from evidence synthesis and the findings are reported in this paper. Results Alignment of transformation work with Best et al’s rules for ‘what works’ in large system transformation varied. Interactions between the rules were identified, indicating that the drivers of large system transformation are interdependent. Key challenges included the pace and scale of change that national policy required, complexity of the existing context, a lack of statutory status for the new ‘system’ limiting system leaders’ power and authority, and concurrent implementation of a new overarching system alongside multifaceted service change. Conclusions Objectives and timescales of transformation policy and plans should be realistic, flexible, responsive to feedback, and account for context. Drivers of large system transformation appear to be interdependent and synergistic. Transformation is likely to be more challenging in recently established systems where the basis of authority is not yet clearly established.

Transformational Change for Achieving Scale: Lessons for a Greener Recovery

Achieving transformational changes that can be then effectively scaled up requires ambition in design, a supportive policy environment, sound project design and implementation, partnerships, and multistakeholder participation. This chapter presents a framework that can be applied at the design stage to plan for change and scaling up and provides relevant lessons based on GEF interventions. Achieving change and scale can be an iterative and a continuous process until impacts are generated at the magnitude and scope of the targeted scale. Successful transformations typically adopt a systems approach and address multiple constraints to attain environmental and other socioeconomic impacts.

Evaluating Transformational Adaptation in Smallholder Farming: Insights from an Evidence Review

The literature on smallholder farming and climate change adaptation (CCA) has predominantly investigated the barriers to and determinants of farmer uptake of adaptation interventions. Although useful, this evidence fails to highlight the changes or persistence of adaptation responses over time. Studies usually adopt a narrow focus on incremental actions that provide limited insights into transformative adaptation pathways and how fundamental shifts in policy can address the root causes of vulnerability across different sectors and dimensions. Drawing on an evidence synthesis commissioned by the International Fund for Agricultural Development’s Independent Office of Evaluation, this chapter outlines how lessons from CCA interventions can be transferred via three learning domains that are essential for transformational change: scaling-up (in its multiple forms), knowledge management, and the human-environment nexus. We discuss the implications of our findings on monitoring, evaluation, and learning, highlighting the challenges that evaluators may face in capturing (a) the persistence or durability of transformational pathways, (b) the complexity of “super-wicked” problems, and (c) the relevance of context-dependent dynamics, within a landscape setting. We also address the contribution of evidence reviews to contemporary debates around development policy linked to climate change and agriculture, and the implications and value of such reviews to provide independent scientific rigor and robustness to conventional programmatic evaluations.

Evaluation for Transformational Change: Learning from Practice

The COVID-19 crisis has challenged the evaluation profession by altering the framework within which it operates. Evaluators must embrace new realities and respond to changes while not altering their principles, norms, and standards.A review of how evaluation networks and offices have responded to changing demands showed lack of recognition for the long-term implications to the profession. Commissioners and users of evaluation now have new priorities, and nontraditional actors have entered the traditional evaluation space, offering similar expertise and meeting the demands of evaluation commissioners and users. The extensive development challenges posed by COVID-19 require a comprehensive response capacity from evaluation if it is to be transformative as a profession.This chapter draws on national and international case studies, examining the concept of transformation from a contextual perspective and noting the relativism in the concept. It draws links between aspects, suggesting that this period is an opportunity for evaluators to learn from practice around transformation, and suggests that flexibility provides an opportunity to remain relevant and advance transformational goals.

Transformational Change for People and the Planet: Evaluating Environment and Development – Introduction

The world is facing multiple crises as manifested in runaway climate change, a global pandemic, loss of ecosystems and biological species, and rapidly growing inequality. These are all closely interlinked as recognized in the 2030 Agenda for Sustainable Development. Addressing them will require broad transformational change that encompasses the economy, institutions, and how we interact with the natural environment. This chapter introduces the book that is intended to highlight how evaluation can contribute to such transformations. The chapter first reviews the state of development evaluation. It then briefly introduces the state of the global environment before discussing the implications of this context for evaluation, and how evaluation as a profession and practice must change in order to respond to the challenges of sustainability. The chapter ends by explaining the flow of the book in its four parts that focus on: transformational change, drivers of sustainability, climate change mitigation and adaptation, and evaluation approaches.

Forging University Social Responsibility Through Community Engagement at Higher Education

This chapter interrogates the notion of community engagement or service learning. The chapter argues that universities pay lip service to community engagement to the detriment of teaching and research functionaries. Most prestige universities operate on the belief that it is only research that matters; hence, research is prioritized. Universities and their staff have adopted an ‘ivory tower' attitude. This modus operandi negates the reality that reliable knowledge could be produced through responsible community engagement and can become the source of empirical data that can be used for teaching and shared through publications. For universities to impact transformational change within and in their surroundings, community engagement should be elevated to equal teaching and learning.

Beyond Pandemic

As the COVID-19 pandemic continues to evolve even beyond a second wave, there is an urgent need for business organisations to rethink and reconfigure their strategies for long-term sustainability beyond the pandemic. Many organisations are already making changes in the way they run their businesses and the way they make decisions to emerge stronger. It can be observed that the pandemic has seriously affected the way business organisations are being operated. However, this research suggests during the discussion that what is required is a transformational change rather than a directed one for any business organisation. In the current scenario, AI is being seen as a key enabler for business organisations to be on the path to recovery. What the ‘modus operandi' beyond the pandemic will be is a relevant issue for businesses indicating further need of research in this area. Using financial analytics and AI in combination will bring in a transformational change that might be viewed as the ‘game changer' for businesses beyond the pandemic.