Download or read book Decreasing Time to Market for a Medical Device New Methods for the Product Development Process written by Kelly Marie Davis and published by . This book was released on 2012 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Through an example, led at a leading medical device company, this dissertation will demonstrate that by applying certain lean principals and tools to the development of a medical device, shortened development times can be obtained. The two papers presented in the dissertation will fill a gap in current literature. Literature presents lean techniques and applications used in many different industries. But, due to the uniqueness of the medical device industry, these general techniques are not ideal. New methods will be used and validated at a medical device company, Covidien. Instead of trying to implement many general lean principals to their projects, these new methods will give medical device companies a step-by-step way to use these principals in a valuable way. The first paper presented in this dissertation uses value stream mapping, Kaizen events, and other lean tools to create a new artwork process for new medical devices going through the product development process. By following the process and methods presented in this paper, a company can rank and select the sub-processes in their product development process that are most important to revamp. The second paper in the dissertation introduces a lean-based theory for setting up the flow for development of a medical device. This theory was designed to be used for either of the U.S. Food and Drug Administration's (FDA) medical device regulatory paths: a premarket approval (PMA) (Class III device) or premarket notification (510(k)) (Class II) project. The proposed development flow is designed to eliminate waste in the development system and decrease overall development time. The methodology behind the theory will be validated through trials at a leading medical device development and manufacturing corporation, Covidien"--Abstract, leaf iv.

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Download or read book Developing Products in Half the Time written by Preston G. Smith and published by John Wiley & Sons. This book was released on 1997-10-30 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advance praise for Developing Products in Half the Time Second Edition New Rules, New Tools Preston G. Smith * Donald G. Reinertsen "This is an exceptional book! Get a new highlighter before you start. There are so many 'ah ha's' in each chapter you will never make it through with an old one." Don LaCombe, Ford Motor Company, Product Development Process Leadership "An excellent book with a strong treatment of the cycle-time consequences of overloading your development capacity. It provides powerful and practical concepts for dealing with this issue." Andrew Aquart, Director Product Development, Cordis, a Johnson & Johnson Company "This is practical, useful stuff for people competing in highly competitive fast moving business." Dr. Paul Borrill, Chief Scientist, Sun Microsystems "3M has absorbed many of the tools from the original edition, and this new one will be even more useful. The topic of incremental innovation is crucial to us, and I really appreciate its balanced treatment." Ronald H. Kubinski, Manager New Product Commercialization Services, 3M Company "As the authors correctly point out, the Fuzzy Front End is the least expensive place to reduce cycle time. This book is one of the only sources of concepts, methods, and metrics for compressing this critical portion of the development process." David M. Lewis, Product Manager, Eastman Kodak Co. "Using these tools we've more than cut our time to market in half. The new edition of this classic crystallizes the synergy of the fast-to-market techniques, and the icons in the margins highlight the opportunities and pitfalls." Mike Brennan , Vice President of Product Development, Black & Decker

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Download or read book Design of an Effective and Timely Product Development Process for Medical Devices written by Jean Benoit Almonor and published by . This book was released on 1998 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: Effective product development process is one of the most critical issues facing medical devices manufacturing today. There is a need to search for ways to improve or solve the cross organization and company boundaries to enhance the faster release of new medical products to the market. This thesis presents an integrated set of perspectives on the process of new product development of medical devices with dual goals of achieving marketing speed and meet customer satisfaction. The Attribute Driven Specifications approach described in this thesis, is one of the most valuable tools in the approach to effective product development in medical devices. This thesis aims to promote effective management of product design and development of medical devices by addressing the inherent complexity and operational reality of the development process of medical devices. Also presented are approaches to product design and development employed by some successful medical device industries.

Download or read book Medical Device Design written by Peter J. Ogrodnik and published by Academic Press. This book was released on 2019-10-30 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

Download or read book Application of 3D Printing in Medical Devices New Product Development written by Michael David Sandford and published by . This book was released on 2017 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: For Johnson & Johnson (J&J), a healthcare industry leader, speed to market is a valuable component of any New Product Development (NPD). This is especially so in its Medical Devices (MD) franchise increased salable lifetime, first mover advantage, customer loyalty, and company reputation for innovation are just some of the reasons that accelerating the pace of development is a priority at J&J. Despite the incentives to speed up the development process, a typical MD product introduction takes three years from initial prototyping to full launch. Over this period, the product is repeatedly refined, prototyped, and tested for reliability and safety prior to production at high volume to meet expected demand. Throughout this process, J&J has historically favored proven manufacturing techniques such as machining and injection molding, which are well understood by the company's designers and manufacturing engineers but lead to long development cycles and high costs when used iteratively, as in NPD. Because new products can improve patient care-which is at the core of J&J's Credo-the company is currently investigating methods to accelerate the NPD process. One way to accelerate development that is being explored is enabled by the burgeoning field of additive manufacturing, or 3D Printing. Traditionally used only for early prototyping and development, innovation in 3D Printing over the past decade and recent FDA guidance on the subject opens the opportunity for its use in late-stage development, tooling, and even end production healthcare products. The scope of this effort was to investigate how MD can use 3D Printing to shorten NPD time from early prototyping through launch, with a target of two months acceleration. Through literature review, expert interviews, and close work with three project teams at J&J over the sixmonth duration of this effort, a portfolio of technical and organizational improvements were identified to improve New Product Development speed in Medical Devices. The use of 3D Printing was found to have a positive impact on all phases of development, ranging from initial design through high-volume manufacturing, with a cumulative effect of over 8 weeks of project-dependent improvement. An organizational structure was proposed to speed adoption of any new technology by using a twofold approach, which focuses on improving both organizational knowledge and internal processes to optimize company value. Additional proposals for using 3D Printing to reduce time to market include: using Direct Metal Laser Sintering (DMLS) for improved injection molding tooling; increasing developer access to local 3D Printing technologies; establishing decision rules to determine appropriate investment in new technology; using polymer 3D Printed injection molds for improved prototyping; increasing minor design iterations to minimize major reliability tests; improving availability of cutting-edge high-volume additive manufacturing technologies; and developing Design for Additive Manufacturing (DFAM) guidelines to decrease the learning curve for engineers. In compilation, these proposals show significant potential to increase the rate of organizational learning around 3D Printing and accelerate the pace of NPD in MD. 3D Printing therefore has the ability to benefit not only J&J's financial position, but also the patients it serves through new products and improved clinical outcomes.

Download or read book Medical Device Innovation Handbook written by William Durfee and published by Lulu.com. This book was released on 2014-03-23 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: A short handbook for the medical device innovator who wishes to understand the innovation process for new medical devices.

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2016-04-19 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable D

Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Download or read book New Product Development written by Sameer Kumar and published by Springer Science & Business Media. This book was released on 2006-10-28 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: The challenge of managing a business enterprise today is to ensure that it can remain efficient and competitive in a dynamic marketplace characterized by high competition, unstable demands, heterogeneous market segments, and short product life cycles. Increasing the pace of new product introduction enables dealing with shorter product lives. To sustain competitiveness, a firm has to be innovative as well as quick to respond to the changing customer needs in order to provide better and faster products to market than competitors. New product development (NPD) is considered as a process of learning. Successful NPD projects typically rely on knowledge and experience of multi-function teams. In addition to corporate strategy and organization learning, the external factors such as, market and competitive conditions also play a big role in driving business strategies. The results from the empirical research study reported shows that companies implementing innovation strategy are more competitive in the long run while those that follow customer-responsive strategy are more likely to have higher return on investment within a shorter time. In order to achieve both sustainable competencies and also meet customer needs in the changing market environment today, a company should adapt to the benefits of both strategies.

Download or read book FDA and Intellectual Property Strategies for Medical Device Technologies written by Gerald B. Halt and published by Springer. This book was released on 2019-01-24 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.

Download or read book Medical Device Product Lifecycle written by Bernadette White and published by Independently Published. This book was released on 2022-03-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to provide an introduction to the application of a lifecycle approach to product design and development for medical devices. Medical Device Product Lifecycle management provides a framework to develop, design maintain user requirements and ensure the safety and performance of medical devices. Application of a Medical Device Product Lifecycle Management benefits the business aspects of manufacturing, fosters alignment across design and development teams and incorporates the voice of the customer, taking into account their needs and safety that is inherent in the design of products. The Medical Device Product Lifecycle (MDPL) relies upon several distinct quality management elements and processes in order to function effectively. These include; principles and establishment of a quality management system, regulatory processes, validation processes, engineering processes, change management and risk management processes. The MDPL process itself requires procedures and documentation to facilitate product realization. For the reader to gain the maximum benefit from this book, the following points should be considered. To begin with-Regulations are mandatory. Medical devices range in their application (intended use and indications), technologies, principles of operation, complexity and value. However, regulation in addition to standards need to be consulted and applied within organizations. The manufacturer has a legal responsibility in this regard and the classification and commercial strategy may require regulations such as FDA 21 CFR 820, (United States), and Medical Device Regulations EU MDR (2017/745) or Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) (in Europe). Introduction Establishing a Medical Device Product Development Process is necessary to for medical device manufacturers to meet FDA regulations and regional regulations applicable to the products for sale. Beyond the legal stipulation, an additional purpose is to realize and deliver safe and effective medical devices that meet the intended use and user needs which provides medical solutions that enhance and preserve quality of life. To achieve safe and effective products, the guiding principles and techniques not only need to be applied in the design and development stages, but maintaining and monitoring the performance through the product lifecycle is required. It is easily to compartmentalize product performance and safety as a development and design-based activity, however, an effective medical device lifecycle process must ensure design safety and continuity until product retirement and discontinuation. The introduction of new medical device products or changes to existing medical device products necessitate design and development activities in order to plan and deliver the appropriate verifications and validations to demonstrate safety and performance of products. Device manufacturers in establishing and applying a Medical Device Product Lifecycle Process must continually ensure the process is fit-for-purpose and that is fulfils its legal and regulatory obligations (e.g. meeting the requirements of 21 CFR 820.30: Medical Devices - Quality System Regulation and ISO 13485: Medical Devices- Quality Management Systems etc.) A Medical Device Product Lifecycle process must be a comprehensive, end-to-end process that encompasses the entire life cycle of a product from project initiation through to product discontinuation and retirement of a marketed product. Making a comprehensive and detailed process intuitive and easy-to-apply should also play a role in designing and maintaining a MDPL process. Structuring the process into specific stages and the use of design review or gate reviews also provides for a format that has milestones and a stage by stage approach that makes it easier for engineers to work with.

Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Download or read book Converging Pharmacy Science and Engineering in Computational Drug Discovery written by Tripathi, Rati Kailash Prasad and published by IGI Global. This book was released on 2024-04-22 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world of pharmaceutical research is moving at lightning speed, and the age-old approach to drug discovery faces many challenges. It's a fascinating time to be on the cutting edge of medical innovation, but it's certainly not without its obstacles. The process of developing new drugs is often time-consuming, expensive, and fraught with uncertainty. Researchers are constantly seeking ways to streamline this process, reduce costs, and increase the success rate of bringing new drugs to market. One promising solution lies in the convergence of pharmacy science and engineering, particularly in computational drug discovery. Converging Pharmacy Science and Engineering in Computational Drug Discovery presents a comprehensive solution to these challenges by exploring the transformative synergy between pharmacy science and engineering. This book demonstrates how researchers can expedite the identification and development of novel therapeutic compounds by harnessing the power of computational approaches, such as sophisticated algorithms and modeling techniques. Through interdisciplinary collaboration, pharmacy scientists and engineers can revolutionize drug discovery, paving the way for more efficient and effective treatments. This book is an invaluable resource for pharmaceutical scientists, researchers, and engineers seeking to enhance their understanding of computational drug discovery. This book inspires future innovations by showcasing cutting-edge methodologies and innovative research at the intersection of pharmacy science and engineering. It contributes to the ongoing evolution of pharmaceutical research. It offers practical insights and solutions that will shape the future of drug discovery, making it essential reading for anyone involved in the pharmaceutical industry.

Download or read book Accelerating Innovation written by Marvin L. Patterson and published by Van Nostrand Reinhold Company. This book was released on 1993 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The time for rehashing America's lost battles on the world market has passed." "Now it's time to address a critical component of the economic battle plan: the product development process that creates the products that satisfy customer needs. How quickly these weapons of economic war are developed, how competitive they are, how timely they are deployed, and how supportable they are will determine the failure or success of American business in the 1990s." "Here is the right book at the right time...a concise blueprint to transform product development from a collection of ad hoc activities into an integrated, smoothly operating process. Written by the Director of Corporate Engineering for Hewlett-Packard, one of the most successfully innovative companies in America today, Accelerating Innovation shows how successful, well-tested concepts from the manufacturing domain can be readily transformed into the needy world of new product innovation." "Filled with clear-sighted analysis and practical explanations, this book will help management unleash innovation and creativity in development processes to meet the urgent need for bringing new technology to customers faster and more effectively than the competition." "Discover how to cope with the limited life span of today's products...anticipate changing consumer needs and desires...close the gap between new technology and products that apply it...bring leading-edge products to market fast...eliminate profit-threatening gaps between the "death" of obsolete products and the introduction of new ones...and enjoy higher returns on investment." "Accelerating Innovation provides a results-oriented model for transferring to product development the strategies that are moving manufacturers from the old era to the new one. Numerous real-life examples give you powerful insights into the time-based factoring and total quality management principles used so successfully in manufacturing and shows how to implement them in the product development cycle. Key chapters address how to shorten the innovation cycle time, applying the principle that success springs from focusing on the right issues; manage organization change so that change goes where you want it to go - and quickly, transfer quality principles used on the assembly line to the process of developing raw information and adding value to it, reduce innovation time by implementing the cost of quality principle (cost as a function of when an error is detected), manage information flow and bottlenecks, minimize changeover time; and much, much more." "Does your organization really have a handle on new product development? Are goals, objectives, processes, metrics, and controls in place? Are you equipped to create new products rationally and systematically, while continuously reducing innovation cycle times?" "Accelerating Innovation presents new thinking that will help you answer these questions with a resounding "yes." In product development, doing business the same old way is a formula for disaster. The time to act is long before the livelihood of the product development function is ever threatened. And if a company is trying to catch up, then it has to improve faster than its toughest competition if it ever expects to win." "Finally, here is a guide that can give you the critical advantage you need for success in product development - success that is no longer a luxury, but a necessity for survival."--BOOK JACKET.Title Summary field provided by Blackwell North America, Inc. All Rights Reserved