Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving.
The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies both what works and what doesn t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html

Analyzing Longitudinal Clinical Trial Data: A Practical Guide provides practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice.The book, with its example-oriented approach that includes numerous SAS and R code fragments, is an essential resource for statisticians and graduate students specializing in medical research. The authors provide clear descriptions of the relevant statistical theory and illustrate practical considerations for modeling longitudinal data. Topics covered include choice of endpoint and statistical test; modeling means and the correlations between repeated measurements; accounting for covariates; modeling categorical data; model verification; methods for incomplete (missing) data that includes the latest developments in sensitivity analyses, along with approaches for and issues in choosing estimands; and means for preventing missing data. Each chapter stands alone in its coverage of a topic. The concluding chapters provide detailed advice on how to integrate these independent topics into an over-arching study development process and statistical analysis plan.

Discover the Latest Statistical Approaches for Modeling Exposure-Response Relationships Written by an applied statistician with extensive practical experience in drug development, Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response modeling, from traditional pharmacokinetic-pharmacodynamic (PKPD) modeling to other areas in drug development and beyond. It incorporates numerous examples and software programs for implementing novel methods. The book describes using measurement error models to treat sequential modeling, fitting models with exposure and response driven by complex dynamics, and survival analysis with dynamic exposure history. It also covers Bayesian analysis and model-based Bayesian decision analysis, causal inference to eliminate confounding biases, and exposure-response modeling with response-dependent dose/treatment adjustments (dynamic treatment regimes) for personalized medicine and treatment adaptation. Many examples illustrate the use of exposure-response modeling in experimental toxicology, clinical pharmacology, epidemiology, and drug safety. Some examples demonstrate how to solve practical problems while others help with understanding concepts and evaluating the performance of new methods. The provided SAS and R codes enable readers to test the approaches in their own scenarios. Although application oriented, this book also gives a systematic treatment of concepts and methodology. Applied statisticians and modelers can find details on how to implement new approaches. Researchers can find topics for or applications of their work. In addition, students can see how complicated methodology and models are applied to practical situations.

An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment's efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.

This book, the first of its kind to treat Uganda, provides a historical analysis of the role of student voices in the development of Uganda's higher education. It not only chronicles incidents of student protests, but also explores and analyses their trigger points as well as the strategies employed by the university, the government, and the students to manage or resolve those crises. In addition, the book highlights the role played by national politics in shaping student political consciousness, in particular their involvement in protests, riots and demonstrations. The book, therefore, limits its scope to the unfolding and impact of student crisis on the process of higher education. Byaruhanga recommends that colleges and universities need to increase communication with students, as well as promote student involvement in decision and policy making, among other things, in order to forestall future conflicts. Most distinctively, the book aims to address the current paucity of research on student activism in Uganda's higher education, and highlights the critical need for research on higher education in Africa as a field of study. The book also may serve as a base for cross-national comparative analysis.

This dissertation examines the cultural and educational history of central Missouri between 1820 and 1860, and in particular, the issue of master-slave relationships and how they affected education (broadly defined as the transmission of Southern culture). Although Missouri had one of the lowest slave populations during the Antebellum period, Central Missouri - or what became known as Little Dixie - had slave percentages that rivaled many regions and counties of the Deep South. However, slaves and slave owners interacted on a regular basis, which affected cultural transmission in the areas of religion, work, and community. Generally, slave owners in Little Dixie showed a pattern of paternalism in all these areas, but the slaves did not always accept their masters' paternalism, and attempted to forge a life of their own.

Understanding the importance and application of biosensors is complicated by the diverse range of methods and application and some existing text is somewhat technical in nature with little consideration to the novice. This book disseminates information on biosensors in a readable way by having unique sections for the novice and expert alike. Each chapter has an abstract, key facts, applications to other areas of health and disease, a "mini-dictionary" of key terms and summary points. In addition, the book covers optical imaging, surface plasmon resonance, microcantilevers, electrochemistry, aptamers, fluorescence, electrochemistry, nanobiosensors and nanowires.

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

Bridging the gap between research and clinical application, Biosensors and Molecular Technologies for Cancer Diagnostics explores the use of biosensors as effective alternatives to the current standard methods in cancer diagnosis and detection. It describes the major aspects involved in detecting and diagnosing cancer as well as the basic elements of biosensors and their applications in detection and diagnostics.

The book addresses cancer molecular diagnostics, including genomic and proteomic approaches, from the perspective of biosensors and biodetection. It explains how to measure and understand molecular markers using biosensors and discusses the medical advantages of rapid and accurate cancer diagnostics. It also describes optical, electrochemical, and optomechanical biosensor technologies, with a focus on cancer analysis and the clinical utility of these technologies for cancer detection, diagnostics, prognostics, and treatment.

Making biosensor technology more accessible to molecular biologists, oncologists, pathologists, and engineers, this volume advances the integration of this technology into mainstream clinical practice. Through its in-depth coverage of a range of biosensors, the book shows how they can play instrumental roles in the early molecular diagnosis of cancer.

One of the first studies of an exciting new development in global biotechnology, this cutting edge text examines the extent of the transnational movements of tissues, stem cells, and expertise, in the developing governance framework of India.

Documenting the impact of local and global governance frames on the everyday conduct of research, this groundbreaking book traces the journey of spare human embryos in IVF clinics to public and private laboratories engaged in isolating stem cells for potential therapeutic application. The discussion also examines the gender dimension as a potential site for exploitation in the sourcing of embryonic and other biogenic materials, and suggests that a moral economy has developed in which the ethical values of the global 'North' support and encourage the donation of abundant and ethically neutral embryos by the 'South'.

This unique exploration is grounded in an empirical, multi-sited ethnographic study that takes a thoroughly comparative analysis of the ethical, religious and social issues in Europe, the United States, and organ donations already prevalent in India. In this theoretically-sensitive analysis, the authors use the resources of social anthropology and the social sciences in an innovative text which will appeal to postgraduates and professionals in the areas of STS studies, genetics, bioethics, and anthropology.

Whilst assisted reproduction techniques (ART) have become increasingly successful and largely standardized, there is still only a partial understanding of what constitutes a 'true' embryo environment. Replicating the varying physiological conditions of the in-vivo environment that the embryo travels through in the in-vitro culture is still a major challenge in ART. This practical volume details how to organize and operate an IVF laboratory in order to mimic these conditions for successful embryo culture. Environments and equipment that are essential for running safe and efficient facilities such as maintaining good air quality and hygiene protocols, and utilizing an effective layout are covered in detail. Other chapters discuss the different consumables needed, optimal handling techniques and parameter monitoring systems, as well as recent advances in the area including artificial intelligence and automation. This is an indispensable guide to understanding the background science of culturing embryos, crucial to successful outcomes in ART.

The leading figure in qualitative health research (QHR), Janice M. Morse, asserts that QHR is its own separate discipline--distinct from both traditional health research and other kinds of qualitative research--and examines the implications of this position for theory, research, and practice. She contends that the health care environments transform many of the traditional norms of qualitative research and shape a new and different kind of research tradition. Similarly, the humanizing ethos of qualitative health research has much to teach traditional researchers and practitioners in health disciplines. She explores how the discipline of QHR can play out in practice, both in the clinic and in the classroom, in North America and around the world. A challenging, thought-provoking call to rethink how to conduct qualitative research in health settings.

Led by both children s rights perspectives and methodological arguments, there is an increasing emphasis on children and young people s participation in health and social care research by researchers, policy makers and funding bodies with many now considering the active involvement of children and young people a requirement. There is little exploration of how to address and overcome the many challenges arising from their participation, however.

Divided into five parts, this practical book begins by considering what research with young people is and why we should do it, before leading the reader into how to undertake it. The book then provides practical examples of action and finishes with reflections about the whole process. Bringing together a variety of experienced researchers, from a wide range of backgrounds in health and social care and including young people, the chapters provide insight for practical action, as well as critical and theoretical reflection. Involving Children and Young People in Health and Social Care Research includes issues on:

• Understanding the reasons and processes for involving children and young people in research
• Making sure that involvement is meaningful and not merely tokenistic
• Developing research methods that are commensurate with different ages and abilities
• Ensuring adequate training and preparation, for children, young people and adults to make involvement meaningful
• Power and relationships between young people researchers and adult researchers
• Sustaining young people s interest and motivation
• Addressing ethical issues that arise throughout the research journey

Committed to partnership and participation throughout the entire process of the active involvement of children and young people in health and social care research, this text provides invaluable insights and is a resource for all those conducting research in and with children and young people.

eHealth Applications: Promising Strategies for Behavior Change provides an overview of technological applications in contemporary health communication research, exploring the history and current uses of eHealth applications in disease prevention and management. This volume focuses on the use of these technology-based interventions for public health promotion and explores the rapid growth of an innovative interdisciplinary field.

The chapters in this work discuss key eHealth applications by presenting research examining a variety of technology-based applications. Authors Seth M. Noar and Nancy Grant Harrington summarize the latest in eHealth research, including a range of computer, Internet, and mobile applications, and offer observations and reflections on this growing area, such as dissemination of programs and future directions for the study of interactive health communication and eHealth.

Providing a timely and comprehensive review of current tools for health communication, eHealth Applications is a must-read for scholars, students, and researchers in health communication, public health, and health education.

This revised third edition has been updated to cover all aspects of chiral drugs from the academic, governmental industrial and clinical perspective reflecting the many advances in techniques and methodology. The title will cover new material including the use of enzymes for the synthesis and resolution of enantiomeric compounds as well, as their use in drug discovery; how stereochemistry impacts on decisions taken during the ADMET (absorption, distribution, metabolism, excretion, toxicity) stage of drug discovery; issues faced during the final stages of the drug development process; the impact of ICH (International Conference on Harmonisation) on the use of single isomer drugs; racemic switches; and legal perspectives looking at IP and patent issues surrounding chiral switches and marketing single enantiomer switches.

This Third Edition comprehensively presents all aspects of chiral drugs from scientific, academic, governmental, industrial, and clinical points of view. This one-stop text covers the lifespan of stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisomeric drugs.

New topics include:

• The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery
• How stereochemistry impacts decisions made in the Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) stages of drug discovery
• A chapter on pharmacokinetics and pharmacodynamics that discusses the issues faced during the final stages of the drug development process
• The impact of International Conference on Harmonisation on the use of single isomer drugs
• Chiral switches
• The concept of molecular chiral recognition and how it affects the separation and behavior of stereochemically pure drugs
• A chapter on the legal perspectives of patent issues surrounding chiral switches and the marketing of single enantiomer switches
• This will be a one-stop shop for pharmaceutical scientists and chemists working with chiral drug molecules
  

Stem cell research and technology represent a major challenge for treating otherwise noncurable patients. A decade of intensive research has demonstrated that initial hopes based more on the will to succeed than on solid scientific bases can be translated into factual techniques only by adopting more rigorous procedures and strategies. Among other major impediments, the failure so far experienced in applying stem cell technologies to repair parenchymal organs can be ascribed to the lack of sufficient knowledge of basic mechanisms, but also to the lack of standardized criteria and protocols. Very often each laboratory follows its own "recipe" using erratic nomenclature and non-comparable, if not confusing, experimental protocols. All this makes it difficult to learn from the others and, ultimately, hampers the advance of knowledge on stem cell behavior. The ambitious goal of Adult Stem Cell Standardization is to gather the most innovative and scientifically robust knowledge and technologies on stem cells and involve investigators from academy and industry in formulating recommendations to standardize the isolation and manipulation of stem cells using solid and well-documented knowledge rather than fragmentary and often unrepeatable experimental reports.

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. New to the Second EditionAlong with revisions throughout the text, this edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. It also includes five entirely new chapters on two-stage adaptive design, biomarker adaptive trials, target clinical trials, sample size and power estimation, and regulatory perspectives. Following in the tradition of its acclaimed predecessor, this second edition continues to offer an up-to-date resource for clinical scientists and researchers in academia, regulatory agencies, and the pharmaceutical industry. Written in an intuitive style at a basic mathematical and statistical level, the book maintains its practical approach with an emphasis on concepts via numerous examples and illustrations.

A reflection of the explosion of research and development in this field, OMICS: Biomedical Perspectives and Applications explores applications of omics in bioinformatics, cancer research and therapy, diabetes research, plant science, molecular biology, and neurosciences. A select editorial panel of experts discusses their cutting edge omics research and novel technologies, supplying a basic platform of methods and applications and a resource for enhanced cross-pollination in a multiomics approach to future endeavors in the fertile fields of omics research.

After an introduction on the omics universe, the book presents modern omics and its applications in nanotechnology, genomics, proteomics, metagenomics, toxicogenomics, immunomics, nutrigenomics, diabetes, neurology, cardiology, and cancer to name just a few. The book begins with an overview of omics and omic technologies such as cellomics, glycomics, and lipidomics. It also discusses bioinformatics, demonstrating how it can be a tool in omics, and examines the various approaches of omics technology in toxicology research and applications in biomedical sciences.

While there are a long list of omics books available, most focus narrowly on one area. Presenting a wide view of the current status of integrative omics, this resource contains complete coverage of omics in research and therapy, ranging from neuroscience to cardiology. It collates recent developments in the field into a state-of-the-art framework for this discipline.

From screening and diagnosis to prevention and treatment, every aspect of gastrointestinal endoscopy as a therapeutic measure is addressed in this volume. The authors are recognized authorities in this field, and in Therapeutic Gastrointestinal Endoscopy they present a problem-oriented, evidence-based textbook. In each chapter, it cites the key medical literature that can be studied for further reference. The book uses dozens of figures, photographs and illustrations to address the key issues of assessment, diagnosis and options for treatment. The authors present cohesive arguments for the preferred chosen management regime.

Healthcare sensor networks (HSNs) now offer the possibility to continuously monitor human activity and physiological signals in a mobile environment. Such sensor networks may be able to reduce the strain on the present healthcare workforce by providing new autonomous monitoring services ranging from simple user-reminder systems to more advanced monitoring agents for preventive, diagnostic, and rehabilitative purposes. Potential services include reminding people to take their medication, providing early warning for the onset of heart attacks or epileptic seizures, and monitoring a child's physical activity in order to assess their growth and mental development. Healthcare Sensor Networks: Challenges Toward Practical Implementation discusses the fundamental concepts in designing and building such networks. It presents the latest developments in HSNs, explores applications of the technology, and provides insights into practical design and deployment challenges. Bringing together contributions from international experts in the field, the book highlights the key areas that require further research for HSNs to become a technological and commercially viable reality. The first part of the book concentrates on the engineering challenges, covering new biosensors, energy harvesting techniques, new wireless communication methods, and novel security approaches. Building from single sensing devices to networked sensing systems, the second part of the book looks at various health applications of HSNs. It addresses the human-centric requirements that should be considered in the design of HSN technologies-cost, portability, functionality, and user acceptance-and demonstrates how engineering compromises must be made in HSN solutions. A useful and timely resource for researchers, postgraduate students, and engineers looking for innovative solutions in healthcare, this book will also be of interest to medical and allied he

Cardiology Science and Technology comprehensively deals with the science and biomedical engineering formulations of cardiology. As a textbook, it addresses the teaching, research, and clinical aspects of cardiovascular medical engineering and computational cardiology. The books consists of two sections. The first section deals with left ventricular (LV) wall stress, cardiac contractility, ventricular remodeling, active wall stress and systolic pressure generation, and vector cardiogram characteristics, with applications in cardiology. The second section covers ECG signal analysis for arrhythmias detection, LV pumping (intra-LV, aortic and coronary flow) characteristics, and coronary bypass surgery design, with applications in cardiology and cardiac surgery. This book is like an exciting train ride through the heart and into blood flows within its chamber, the coronary tree, the aorta, and finally into coronary flow and bypass grafting. The train starts from the heart's central station and journeys through exciting places of heart wall stresses, cardiac contractility measures to characterize heart failure, and active stress generation to develop systolic heart pressure. We learn about cardiomyopathic heart remodeling and its surgical ventricular restoration, theory of ECG and vector cardiogram with medical applications, and heart rate variability signal processing to detect cardiac arrhythmias. In the heart chamber, we witness the amazing intricate intra-ventricular flow patterns. Then, we study pressure pulse wave propagation into the aorta, determination of pulse wave velocity and arterial elasticity as a measure of arteriosclerosis. We climb into the mountainous coronary terrain and look at the fascinating scenery of coronary flows and myocardial perfusion that governs cardiac contractility. Finally, we arrive at coronary bypass grafting and witness the new sequential anastomosis design for enhanced patency.

The entire scope of the BioMEMS field-at your fingertipsHelping to educate the new generation of engineers and biologists, Introduction to BioMEMS explains how certain problems in biology and medicine benefit from and often require the miniaturization of devices. The book covers the whole breadth of this dynamic field, including classical microfabrication, microfluidics, tissue engineering, cell-based and noncell-based devices, and implantable systems. It focuses on high-impact, creative work encompassing all the scales of life-from biomolecules to cells, tissues, and organisms. Brilliant color presentationAvoiding the overwhelming details found in many engineering and physics texts, this groundbreaking book-in color throughout-includes only the most essential formulas as well as many noncalculation-based exercises. Important terms are highlighted in bold and defined in a glossary. The text contains more than 400 color figures, most of which are from the original researchers. Coverage of both historical perspectives and the latest developmentsDeveloped from the author's long-running course, this classroom-tested text gives readers a vivid picture of how the field has grown by presenting historical perspectives and a timeline of seminal discoveries. It also describes numerous state-of-the-art biomedical applications that benefit from "going small," including devices that record the electrical activity of brain cells, measure the diffusion of molecules in microfluidic channels, and allow for high-throughput studies of gene expression.

The discovery of the two inherited susceptibility genes BRCA1 and BRCA2 in the mid-1990s created the possibility of predictive genetic testing and led to the establishment of specific medical programmes for those at high risk of developing breast cancer in the UK, US and Europe. The book provides a coherent structure for examining the diversity of practices and discourses that surround developments linked to BRCA genetics, and to the evolving field of genetics more broadly. It will be of interest to students and scholars of anthropology, sociology, history of science, STS, public health and bioethics. Chapter 8 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://s3-us-west-2.amazonaws.com/tandfbis/rt-files/docs/Open+Access+Chapters/9780415824064_oachapter8.pdf