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Because the coronavirus disease 10 (COVID-19) pandemic has significantly altered cardiovascular care, we sought to investigate whether the number of reports of adverse events attributed to percutaneous catheter ablation devices changed over the course of the pandemic, specifically examining three medical device classes: cardiac ablation percutaneous catheters; cardiac ablation percutaneous catheters for treatment of atrial fibrillation; and cardiac ablation percutaneous catheters for treatment of atrial flutter. Using data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, we compared weekly reported rates of adverse events for each device during the year immediately preceding the pandemic (March 2019-March 2020) to those during the first year of the pandemic (March 2020-March 2021). We report a 19% decrease in reported malfunctions related to cardiac ablation percutaneous catheters during the pandemic compared to pre-pandemic. We further report a 23% decrease in reported malfunctions related to cardiac ablation percutaneous catheters for atrial fibrillation during the pandemic compared to pre-pandemic. Finally, we report a 25% decrease in reported injuries related to cardiac ablation percutaneous catheters for atrial flutter during the pandemic compared to pre-pandemic.

Shifts in care delivery during the COVID-19 pandemic, particularly from surgical aortic valve replacement to percutaneous aortic valve replacement, may have had adverse outcomes for patients. We analyzed data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, to determine trends in reported malfunctions, injuries, and deaths for transcatheter aortic valve prostheses during the decade 2012 to 2021. We find that reported deaths attributed to transcatheter aortic valve prostheses more than doubled from the pre-pandemic year of 2019 to the pandemic year of 2020. Monthly reported deaths attributed to transcatheter aortic valve prostheses increased by 124%, from 25.0 monthly deaths in 2019 to 55.9 monthly deaths in 2020 (p

Regular cardiology practices were interrupted by the COVID-19 pandemic. To better understand the pandemic’s effects on cardiology practices, we investigated whether the pandemic affected reporting of cardiovascular medical device failure by examining whether adverse event reports per week attributed to different cardiovascular devices changed significantly during the pandemic. By using data from FDA’s MAUDE database, we compared weekly rates of adverse event reports over the course of three years attributed to each of four devices: ‘Implantable Cardioverter Defibrillator (Non-CRT)’, ‘Coronary Drug-Eluting Stent’, ‘Aortic Valve, Prosthesis, Percutaneously Delivered’, and ‘Heart Valve, Non-Allograft Tissue’. Specifically, we looked at trends per week for the adverse events 'Malfunction’, ‘Injury’, and ‘Death’ for March 2018-March 2019, the pre-pandemic year of March 2019-March 2020, and the pandemic year March 2020-March 2021. We report a 46% decrease in reported deaths attributed to ICDs, a 27% decrease in reported injuries attributed to coronary DES, a 107% increase in reported deaths and a 45% increase in reported malfunctions attributed to percutaneous aortic valve prostheses, as well as a 27% decrease in reported injuries attributed to non-allograft tissue heart valves (all comparisons pandemic to pre-pandemic). That these four cardiovascular medical devices did not homogeneously increase or decrease suggests that changing care patterns that differently affected each device were the root of these trends, rather than a broader factor like underreporting which one would expect to affect the devices similarly.

When we close our eyes and picture a humanitarian crisis, we are likely to see an aurora of chaos, conflict, anger, fear, and mortality that lingers over a large group of people. However, we are also likely to see a slew of responding multilateral relief agencies and nongovernmental organizations (NGOs) that deploy and respond to catastrophe. The deployment of these agencies, whether it be the United Nations (UN), the US Agency for International Development (USAID), the World Health Organization (WHO), etc., generally follows a very long and complex interventional deployment strategy that involves numerous operating components. The aid delivery complex is generally not streamlined and often deals with a wealth of bureaucracy and dissonance between intervening agencies and the host country they are operating in. We can see how complex this process is from previous historical events such as the Haitian Earthquake in 2010 or the Rwandan genocide in 1994, where the very same agencies—i.e., the UN in these cases—that were supposed to help, actually become implicated in not providing adequate relief services. The interventional capacity of any agency is vital in not only stabilizing and promoting conflict resolution but also in the delivery of human health services via humanitarian medicine. Aid and relief practitioners and workers rely on access to equipment, services, and tools in order to provide adequate treatment and palliative care. What we will seek further on in this work is that oftentimes these individuals do not have sufficient access to the resources and materials they need to deliver care and health services to not only treat acute maladies but also chronic ones as well. But first we begin by defining the humanitarian aid complex and its deployment in real-world settings, emergencies, and crises around the world.

The term “innovation” is typically rooted in ambiguity, as it is often defined in an array of contexts, adaptations, and subject matters. Its definition ranges from the simple notion of being a new idea or method to the more robust application of enhanced solutions that meet unarticulated or existing market needs (Baregheh et al. 2009). The reality is that it is an umbrella term that describes the essence of human ingenuity and discovery, essentially an impetus for creating breakthroughs in problem-solving. This book is unique in that we garner a spectrum of distinct innovation processes and dissect them in order to divulge novel ways of improving humanitarian medicine and human health. Innovation gives way to an array of thought processes that all serve the same purpose—to enhance the way we solve problems. When it comes to the realm of human health, innovations have the capacity to enact change by quite literally having the capacity to save lives and improve quality of life. Innovation has no greater impact and application than in the scope of human health and medicine, as it has boundless potential to change the world around us. In delving deeper into the applications of innovation in human health, humanitarian medicine is perhaps one the most vital areas of application. What is unique about humanitarian aid, whether it be in the scope of disaster, relief, or general aid operations, is that it is comprehensive in relation to the human condition. These initiatives typically involve the delegation of clean water, surveillance, sanitation, emergency care, social services, preventative care, infectious disease mitigation, and clinical care. This means that the application of innovations must be targeted in scope and refined to be feasible and easily deployable in these environments. This is where bridging the gap between theory and application comes into play. While many times innovation is touted as the answer to solving humanity’s most pressing problems, how exactly do we turn unconventional “out-of-the-box” ideas into feasible, conventional solutions? We explore this next in defining the four types of innovation processes that can serve as an impetus for enhancing humanitarian medicine.

In our previous chapter, we explore the various innovation processes that comprise frugal innovation as well as novel innovation paradigms including open and reverse innovation. Importantly, we not only define the theoretical dimensions of these innovation processes but also the functional outputs in the form of tangible technologies/devices. But while the intellectual components of these processes are critical, what does this mean for the future of humanitarian medicine and innovation? The fact of the matter is that the deployment of innovation processes in conflict and crisis situations will likely consist of an amalgam of these processes that is utilized as a catalyst for high-functioning problem-solving in the field. The reality is that crisis and conflict situations are not black and white; thus the solutions developed in the field are likely to reflect this. This is where we examine the field-based applications of these technologies and their specific capacities to preserve human life. But before we delve into these medical devices, who are these devices meant for? There are three critical stakeholders in any humanitarian healthcare operation: humanitarian practitioners (i.e., doctors, nurses, aides, relief workers), community health workers (i.e., frontline public health workers from indigenous communities), and crisis-stricken communities themselves. While the scope and capacity to utilize devices varies among these groups, nonetheless, it is vital that each one of these stakeholders be properly retrofitted with the most basic of equipment, technology, and devices. In this book we take this a step further and examine how we can not only enhance the retrofitting of humanitarian operators but also their respective problem-solving and innovation processes to create “adaptive solutions.” We define these as high-utility, unconventional solutions that are derived in resource-poor settings. The reality is that while we can provide frugal devices to individuals, how do we stimulate continued innovation and the implementation of adaptive solutions on the ground? The innovation process is just as important as the device itself—a paradigm that is often overlooked.

The ultimate goal humanitarian operations and innovation in general is to improve and enhance the human condition. With regard to humanitarian medicine and innovation, this is taken a step further with the fundamental element of alleviating human suffering and saving lives in the field. While the intentions are indeed very noble, innovation must be fostered by an evidence-based approach in conjunction with the tenets of human ingenuity. While indeed ideas open the door to novel interventions, if we are to make a true impact on the more than 63 million displaced refugees and conflict victims around the world, we must turn thought into action. The foundations provided in this book seek to take the ambiguity out of “innovation” and define its process, philosophy, and practical applications both now and in the future. Humanitarian innovation is perhaps the most extreme application of innovation, as it embraces the notion of creating something out of very limited resources. While indeed many may think that having limited resources serves as a detriment to the innovation process, we think quite the opposite. Resource-poor settings and unconventional environments employ people to think harder, deeper, and more efficiently. This creates a selection process whereby only the most practical and feasible ideas are embraced and pursued. At the end of the day, this breeds functional breakthroughs and innovations that display the same functional utility as those developed with ample resources. Furthermore, innovation is not embraced solely by highly educated professionals, researchers, academics, etc., but rather knows no bounds. The recipients and users of technological innovations often have as much or even more potential to innovate than the purveyors/creators of the innovation themselves. Ultimately, working together across geographic, socioeconomic, and geopolitical spectrums fosters dynamic creativity, enhanced problem-solving, as well as creates a better innovation. Human suffering is often viewed in the short-term in humanitarian operations; thus the interventions promoted are not suitable for perpetual application. By creating an innovation ecosystem that embraces the integration of an array of innovations ranging from 3D printing prosthetics to mHealth and blockchain technologies, we create infrastructure and human capital that will last into the future. This is where the notion of empowering refugee and conflict victim innovation comes into play. Who better to know the true realm of human suffering and the key to alleviating it than the actual people experiencing it firsthand. The future of humanitarian innovation lies not solely in the creation of novel technologies, devices, and interventions but more importantly in the knowledge transfer created and fostered. Health is fundamental element of the human condition, in which the bilateral transfer of knowledge is critical to empowering displaced individuals and promoting social equity.

Improving the medical outcomes for pneumonia, traumatic injuries, and diarrheal diseases extends beyond the overall health of affected individuals. The health of a country is innately tied to the corresponding wealth of that country, in which healthy individuals foster increased productivity and economic gains on both local-level and macro-level scales. In acknowledging this, there are additional steps that Nigeria can consider in the area of biomaterials science that may lead to greater health and economic sustainability. The primary concern is the health of future generations in combating conditions and morbidities that afflict the youth population and human capital development and minimizing the risks associated with increased economies of scale related to the future development of bio-economies. Biomaterials have the potential to foster advancements on multiple fronts but require an integrative approach to making sure that future initiatives are both sustainable in nature as well as help those that are in need of these interventions the most.

Given the growing global burden of disease, novel treatment strategies are needed to address a multitude of health maladies and conditions. In acknowledging this, we use Nigeria as case study where feasible, functional interventions that utilize bio-based materials can be deployed infield at healthcare facilities to improve healthcare access, delivery, and most importantly, the quality of life for people. As previously mentioned, pneumonia, diarrheal disease, and traumatic injuries are among the top causes of morbidity and mortality for children under the age of 5 in countries such as Nigeria. In this chapter, each condition is discussed in terms of the clinical prognosis, current shortfalls in mechanisms for treatment, and the role-specific biomaterials could play in improving outcomes. The primary agricultural crops considered are soybeans, corn, and kenaf, for the introduction of biomaterials to manage these complex diseases, pathologies, and traumatic injuries.

Tissue engineering is rapidly progressing from a research-based discipline to clinical applications. Emerging technologies could be utilized to develop therapeutics for a wide range of diseases, but many are contingent on a cell scaffold that can produce proper tissue ultrastructure. The extracellular matrix, which a cell scaffold simulates, is not merely a foundation for tissue growth but a dynamic participant in cellular crosstalk and organ homeostasis. Cells change their growth rates, recruitment, and differentiation in response to the composition, modulus, and patterning of the substrate on which they reside. Cell scaffolds can regulate these factors through precision design, functionalization, and application. The ideal therapy would utilize highly specialized cell scaffolds to best mimic the tissue of interest. This paper discusses advantages and challenges of optimized cell scaffold design in the endoderm, mesoderm, and ectoderm for clinical applications in tracheal transplant, cardiac regeneration, and skin grafts, respectively.

This work examines pluronic F-127 poloxamer for cell protection during injection through a syringe needle. Direct cell injection is a minimally invasive method for cell transplantation; however, it often results in poor cell viability. We proposed that encapsulating cells in this hydrogel would protect cells from detrimental mechanical forces during injection and increase cell viability. The hydrogel was tested at multiple weights and carbon nanobrush concentrations to determine how gel weight affects cell viability as well as to allow the gels to remain as electrically conductive scaffolds. This work assessed the ability of the hydrogel to prevent cell membrane bursting. We used D1 multipotent mouse bone marrow stromal precursor cells for this study. We found that the pressure drop increases with increasing weight of the gels. However, cell viability also increases as the weight of the gels increases. These results support the proposition that hydrogels can be used to protect cells during syringe needle injection. Since these hydrogels undergo a reverse phase transition, the gels can be used to transplant cells into the body in solution form through injection. The gels will then harden in situ to allow for cell proliferation and tissue regeneration at the desired site.

This paper presents a broad review on the recent advances in the research and development of biobased plastics and bionanocomposites that are used in various applications such as packaging, durable goods, electronics and biomedical uses. The development of biobased materials is driven by renewability, low carbon footprint and in certain cases biodegradability (compostability) issues and helped them in moving from niche markets to high-volume applications. The inherent drawbacks of some biobased plastics such as the narrow processing window, low heat deflection temperatures, hydrophilicity, poor barrier, and conductivity and inferior biocompatibility can be overcome by bionanocomposites. The first part of the paper reviews the recent advances in the development of biobased and biodegradable materials from renewable resources and their advantages and disadvantages. In the second part, various types of bionanocomposites based on four types of fillers i.e. nanocellulose, carbon nanotubes, nanoclays, and other functional nanofillers are discussed. This review also presents up-to-date progress in this area in terms of processing technologies, product development and applications.

Approximately 5 billion people around the world do not have access to safe, affordable surgical services when needed (Meara et al. in The Lancet, 386(9993):569–624, 2015). In further exploring the nature of this startling figure, an interesting trend becomes further apparent. Inequities related to access to surgical services becomes stratified based upon relative income distribution of countries. Simply stated, accessibility to surgical services varies in each country based upon their respective income classification. The World Bank classifies countries according to four income groupings, in which income is measured using gross national income (GNI) per capita, in U.S. dollars (Debas et al. in Disease control priorities, (Volume 1): Essential surgery. World Bank Publications, 2015). These four classifications are as follows: low-income countries (LICs) = $1045 or less, Middle-income countries (MICs) which are subdivided into lower-middle-income = $1046 to $4125 and upper-middle-income (UMICs) = $4126 to $12,745, and finally high-income countries (HICs) = $12,746 or more as shown in Fig. 1.1 (Debas et al. in Disease control priorities, (Volume 1): Essential surgery. World Bank Publications, 2015). Upon examination of these income classifications, stratification in accessibility to surgical services becomes evident, with the countries having the lowest gradients in accessibility to surgical services being that of low and middle-income countries (LMICs).

In the previous chapter, we defined the evolution and advancement of 3-dimensional printing technologies and the transformation of these devices from rather primitive machines to highly adaptable modular apparatuses.

Applications 3-dimensional printing technology, specifically that of the RepRap FDM printing apparatus, can vastly enhance the surgical capacity of health facilities in developing countries. In defining the problem of disparities and lack of adequate surgical care, once again the fundamental problem of medical

Regardless of economic classification, humanity as a whole finds itself in a perpetual state of change and development that is nurtured by our intrinsic need as a species to consistently innovate in order to develop novel solutions to society’s most pressing issues. In this perpetual state of change, elements such as our innate drive for intellectual inquiry and curiosity serve as impetuses for innovation. This intellectual inquiry and curiosity that is innately embedded in our human nature, provides a foundation for technological advancement in today’s modern society. One particular technology that has recently grown exponentially is that of rapid prototyping (RP) otherwise known as 3-dimensional (3D) printing. 3D printing technology has seen a myriad of advancement since its initial inception in the early 1980s, and has been radically transformed with the advent of the Internet and innovations in the computer and software technology. With these rapid advancements in this technology coupled with continued research and development, these printing technologies have become more financially feasible and have vastly expanded in their respective interventional applications and capacities. Whereas 3D printers used to cost tens of thousands of dollars only a decade ago, these printing devices can now be purchased for hundreds of dollars (Hostettler in Technologies for development. Berlin: Springer, 2015). In addition, the scaling and applications of this technology has rapidly expanded, in which these units can be utilized to print mono-synthetic small-scale models to that of full-sized automobile parts (Hostettler in Technologies for development. Berlin: Springer, 2015).

The global health arena surmises the entire span of our world and its human populous. This “arena” contains the entirety of our human population and with that population, the health threats that constantly shape our future. In acknowledging the global arena for which we find ourselves in, it is important that the innovations and technologies rendered to help our fellow man are also available to all within the confines of this metaphysical arena. Innovations in science, technology, and medicine must not be available to only a segment of individuals who understand and can harness it. Rather, it is within the adaptability complex of these innovations that the true essence of “innovation” comes to fruition.

Coagulation has long been known to facilitate metastasis. To pinpoint the steps where coagulation might play a role in the metastasis, we used three-dimensional visualization of direct infusion of fluorescence labeled antibody to observe the interaction of tumor cells with platelets and fibrinogen in isolated lung preparations. Tumor cells arrested in the pulmonary vasculature were associated with a clot composed of both platelets and fibrin(ogen). Initially, the cells attached to the pulmonary vessels were rounded. Over the next 2 to 6 hours, they spread on the vessel surface. The associated clot was lysed coincident with tumor cell spreading. To assess the importance of clot formation, we inhibited coagulation with hirudin, a potent inhibitor of thrombin. The number of tumor cells initially arrested in the lung of hirudin-treated mice was essentially the same as in control mice. However, tumor cell spreading and subsequent retention of the tumor cells in the lung was markedly inhibited in the anticoagulated mice. These associations of the tumor cells with platelets were independent of tumor cell expression of P-selectin ligands. This work identifies tumor cell spreading onto the vascular surface as an important component of the metastatic cascade and implicates coagulation in this process.

Adequate consumption of carotenoids including lycopene, β-carotene, lutein, zeaxanthin, and astaxanthin have many benefits for human health. In plants, carotenoids are derived from isoprenoid precursors from the 2-C-methyl-d-erythritol 4-phosphate (MEP) pathway located in plastids. The MEP pathway is also required for the biosynthesis of chlorophyll, terpenoids, plant hormones, and other metabolites. Despite its complexity and difficulty, various strategies have been successfully used to improve the carotenoid biosynthesis in plants through metabolic engineering. Here, these metabolic engineering strategies are reviewed. In addition, the development of gene stacking technologies for carotenoid biosynthesis is evaluated. These technologies will expedite our efforts to bring the health benefits of carotenoids and other nutritional compounds to our diet.