Patients And Caregivers As Developers Of Medical Devices

Moritz Göldner analyzes the unexplored phenomenon of patients and caregivers as innovators with respect to their own unmet medical needs in two complementary studies. In study 1 he uses a mixed-method approach to analyze quantitative data from two datasets on more than 1,100 medical smartphone apps each and qualitative data from 16 interviews with developers of medical apps. He finds substantial evidence that patients and caregivers develop medical apps and shows that those apps receive significantly better ratings than company-developed apps. In study 2 he further explores the commercialization activities of patients and caregivers by analyzing 14 case studies of patients and caregivers who successfully brought their tangible medical device on the market. He finds that those innovators did not maximize their profits, but rather sought to market their devices at reasonable prices to offer access to many other patients. The author discusses these insights and draws conclusions for scholars and managers that are valid beyond this extreme case of user innovation. About the author Moritz Göldner is an innovation consultant for user-centered innovation in (digital) healthcare. Prior to this position, he was a project manager and research associate at the Institute for Technology and Innovation Management at Hamburg University of Technology. His research interests cover user innovation in healthcare, social innovation, the emergence of new medical technologies, as well as entrepreneurship.

Moritz Göldner analyzes the unexplored phenomenon of patients and caregivers as innovators with respect to their own unmet medical needs in two complementary studies. In study 1 he uses a mixed-method approach to analyze quantitative data from two datasets on more than 1,100 medical smartphone apps each and qualitative data from 16 interviews with developers of medical apps. He finds substantial evidence that patients and caregivers develop medical apps and shows that those apps receive significantly better ratings than company-developed apps. In study 2 he further explores the commercialization activities of patients and caregivers by analyzing 14 case studies of patients and caregivers who successfully brought their tangible medical device on the market. He finds that those innovators did not maximize their profits, but rather sought to market their devices at reasonable prices to offer access to many other patients. The author discusses these insights and draws conclusions for scholars and managers that are valid beyond this extreme case of user innovation. About the author Moritz Göldner is an innovation consultant for user-centered innovation in (digital) healthcare. Prior to this position, he was a project manager and research associate at the Institute for Technology and Innovation Management at Hamburg University of Technology. His research interests cover user innovation in healthcare, social innovation, the emergence of new medical technologies, as well as entrepreneurship.

Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range o

Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.

This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readers will gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate.