This book is the culmination of six years of research conducted at the Harvard Business School on how different manufacturing firms around the world approach the development of new products. Its principal focus is the impact of strategy, organization, and management on this critical component of business strategy.
The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.
This book of proceedings is the synthesis of all the papers, including keynotes presented during the 20th CIRP Design conference. The book is structured with respect to several topics, in fact the main topics that serve at structuring the program. For each of them, high quality papers are provided. The main topic of the conference was Global Product Development. This includes technical, organizational, informational, theoretical, environmental, performance evaluation, knowledge management, and collaborative aspects. Special sessions were related to innovation, in particular extraction of knowledge from patents.
Product development teams are composed of an integrated group of professionals working from the nascent stage of new product planning through design creation and design review and then on to manufacturing planning and cost accounting. An increasingly large number of graduate and professional training programs are aimed at meeting that need by creating a better understanding of how to integrate and accelerate the entire product development process. This book is the perfect accompaniment and a comprehensive guide. The second edition of this instructional reference work presents invaluable insight into the concurrent nature of the multidisciplinary product development process. It can be used in the traditional classroom, in professional continuing education courses or for self-study. This book has a ready audience among graduate students in mechanical and industrial engineering, as well as in many MBA programs focused on manufacturing management. This is a global need that will find a receptive readership in the industrialized world particularly in the rapidly developing industrial economies of South Asia and Southeast Asia. - Reviews the precepts of Product design in a step-by-step structured process and focuses on the concurrent nature of product design - Helps the reader to understand the connection between initial design and interim and final design, including design review and materials selection - Offers insight into roles played by product functionality, ease-of assembly, maintenance and durability, and their interaction with cost estimation and manufacturability through the application of design principles to actual products
This book showcases over 100 cutting-edge research papers from the 4th International Conference on Research into Design (ICoRD’13) – the largest in India in this area – written by eminent researchers from over 20 countries, on the design process, methods and tools, for supporting global product development (GPD). The special features of the book are the variety of insights into the GPD process, and the host of methods and tools at the cutting edge of all major areas of design research for its support. The main benefit of this book for researchers in engineering design and GPD are access to the latest quality research in this area; for practitioners and educators, it is exposure to an empirically validated suite of methods and tools that can be taught and practiced.
New product development is not just about creating successful new products. This book presents a blend of cases, original survey research and theory to show the principles used by successful firms in developing new products and pruning those that hold the company back.
Iteration rules product development, but it isn't enough to produce dramatic results. This book champions Radical Product Thinking, a systematic methodology for building visionary, game-changing products. In the last decade, we've learned to harness the power of iteration to innovate faster—we've invested in a fast car, but our ability to set a clear destination and navigate to it hasn't kept up. When we iterate without a clear vision or strategy, our products become bloated, fragmented, and driven by irrelevant metrics. They catch “product diseases” that often kill innovation. Radical Product Thinking (RPT) gives organizations a repeatable model for building world-changing products. The key? Being vision-driven instead of iteration-led. R. Dutt guides readers through the five elements of the methodology (vision, strategy, prioritization, execution and measurement, and culture) to develop a clear process for translating vision into reality, and turning RPT skills into muscle memory. This book offers refreshing solutions to the shortcomings of our current model for product development; be prepared to toss out everything you know about a good vision and learn how to measure progress to create revolutionary products. The best part? You don't have to be a natural-born visionary to produce extraordinary results.
"This book provides a detailed view on the current issues, trends, challenges, and future perspectives on product design and development, an area of growing interest and increasingly recognized importance for industrial competitiveness and economic growth"--Provided by publisher.
"The P-51 Mustang—perhaps the finest piston engine fighter ever built—was designed and put into flight in just a few months. Specifications were finalized on March 15, 1940; the airfoil prototype was complete on September 9; and the aircraft made its maiden flight on October 26. Now that is a lean development process!" —Allen Ward and Durward Sobek, commenting on the development of the P-51 Mustang and its exemplary use of trade-off curves. Shingo Research and Professional Publication Award recipient, 2008 Despite attempts to interpret and apply lean product development techniques, companies still struggle with design quality problems, long lead times, and high development costs. To be successful, lean product development must go beyond techniques, technologies, conventional concurrent engineering methods, standardized engineering work, and heavyweight project managers. Allen Ward showed the way. In a truly groundbreaking first edition of Lean Product and Process Development, Ward delivered -- with passion and penetrating insights that cannot be found elsewhere -- a comprehensive view of lean principles for developing and sustaining product and process development. In the second edition, Durward Sobek, professor of Mechanical and Industrial Engineering at Montana State University—and one of Ward’s premier students—edits and reorganizes the original text to make it more accessible and actionable. This new edition builds on the first one by: Adding five in-depth and inspiring case studies. Including insightful new examples and illustrations. Updating concepts and tools based on recent developments in product development. Expanding the discussion around the critical concept of set-based concurrent engineering. Adding a more detailed table of contents and an index to make the book more accessible and user-friendly. The True Purpose of Product Development Ward’s core thesis is that the very aim of the product development process is to create profitable operational value streams, and that the key to doing so predictably, efficiently, and effectively is to create useable knowledge. Creating useable knowledge requires learning, so Ward also creates a basic learning model for development. But Ward not only describes the technical tools needed to make lean product and process development actually work. He also delineates the management system, management behaviors, and mental models needed. In this breakthrough text, Ward: Asks fundamental questions about the purpose and “value added” in product development so you gain a crystal clear understanding of essential issues. Shows you how to find the most common forms of “knowledge waste” that plagues product development. Identifies four “cornerstones” of lean product development gleaned from the practices of successful companies like Toyota and its partners, and explains how they differ from conventional practices. Gives you specific, practical recommendations for establishing your own lean development processes. Melds observations of effective teamwork from his military background, engineering fundamentals from his education and personal experience, design methodology from his research, and theories about management and learning from his study of history and experiences with customers. Changes your thinking forever about product development.
Sustainable Manufacturing examines the overall sustainability of a wide range of manufacturing processes and industrial systems. With chapters addressing machining, casting, additive and gear manufacturing processes; and hot topics such as remanufacturing, life cycle engineering, and recycling, this book is the most complete guide to this topic available. Drawing on experts in both academia and industry, coverage addresses theoretical developments and practical improvements from research and innovations. This unique book will advise readers on how to achieve sustainable manufacturing processes and systems, and further the clean and safe environment. This handbook is a part of the four volume set entitled Handbooks in Advanced Manufacturing. The other three address Advanced Machining and Finishing, Advanced Welding and Deforming, and Additive Manufacturing. - Provides basic to advanced level information on various aspects of sustainable manufacturing - Presents the strategies and techniques to achieve sustainability in numerous areas of manufacturing and industrial engineering such as environmentally benign machining, sustainable additive manufacturing, remanufacturing and recycling, sustainable supply chain, and life cycle engineering - Combines contributions from experts in academia and industry with the latest research and case studies - Explains how to attain a clean, green, and safe environment via sustainable manufacturing - Presents recent developments and suggests future research directions