Biodesign: The Process of Innovating Medical Technologies

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Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. A three-step, proven approach to the biodesign innovation process - identify, invent, implement - provides a practical formula for innovation. The experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, offer a realistic, action-orientated roadmap for successful biodesign innovation. Real-world examples, end-of-chapter projects, and Getting Started sections guide the reader through each of the key stages of the process and provide a template to create their own new medical devices. Addressing common medical, engineering, and business challenges to develop well-rounded expertise, this book is the complete package for any biodesign entrepreneur. The text is supported by valuable resources, including up-to-date industry changes: found at ebiodesign.org.
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About the author

Stefanos Zenios is the Charles A. Holloway Professor at the Graduate School of Business, Stanford University. His pioneering work on maximizing the benefits of medical technology to patients when resources are limited has influenced policies in the US and Europe. He has quantified the ethical implications of technology allocation choices on patients and society as featured in the Financial Times and Times.com. At Stanford University, he was the first to introduce courses on the interface between medicine, engineering, and management in the MBA curriculum. Dr Zenios advises medical device and biopharmaceutical companies on health economics and outcomes studies for marketing and reimbursement strategies. He is also a co-founder of Culmini Inc., a company funded by the National Institutes of Health to develop web-tools that help patients and families with difficult choices.

Josh Makower is the founder and Chief Executive Officer of ExploraMed, a medical device incubator. He is also a Venture Partner with New Enterprise Associates, a Consulting Associate Professor at Stanford University Medical School, and a co-founder of Stanford Biodesign Innovation Program. Dr Makower has founded several medical device businesses including Moximed, Vibrynt, NeoTract, Acclarent, TransVascular and EndoMatrix. Up until 1995, he was founder and Manager of Pfizer Strategic Innovation Group. He holds over 50 patents in various fields of medicine and surgery, an MBA from Columbia University, an M.D. from NYU, and an S.B. in Mechanical Engineering from MIT.

Paul Yock is the Director of the Stanford Biodesign Program and the founding Co-Chair of the Department of Bioengineering at Stanford University. He is known internationally for his work in inventing, developing, and testing new medical devices, including the Rapid Exchange balloon angioplasty and stenting system, which is now the principal system in use worldwide. He also authored the fundamental patents for mechanical intravascular ultrasound imaging and founded Cardiovascular Imaging Systems. In addition, he invented a Doppler-guided access system known as the Smart Needle and PD-Access. Dr Yock holds 55 US patents and has authored over 300 papers, mainly in the area of catheter-based interventions and technologies. He has been elected to membership in the National Academy of Engineering and has received several prestigious awards, including the American College of Cardiology Distinguished Scientist Award.

Todd J. Brinton is a Clinical Assistant Professor of Medicine (Cardiovascular) and Bioengineering (by courtesy) at Stanford University. He is an interventional cardiologist at Stanford University Medical Center and investigator in interventional-based therapies for coronary disease and heart failure. He is also the Fellowship Director for the Biodesign Program, and Co-Director of the graduate class in Biodesign Innovation at Stanford University. Dr Brinton completed his medicine, cardiology, and interventional training at Stanford University. He holds an M.D. from the Chicago Medical School and a B.S. in bioengineering from the University of California, San Diego. He is co-founder of BioParadox, Inc., a venture-backed medical device company and serves on the advisory board for a number of early-stage medical device companies. Prior to medical school he was the Clinical Research Director for Pulse Metric, Inc., a medical device start-up company.

Uday N. Kumar is the founder and Chief Medical Officer of iRhythm Technologies, Inc., a venture-backed medical device company focused on developing new devices and systems for the detection of cardiac rhythm disorders. He is also the Associate Director, Curriculum of Stanford-India Biodesign and a Lecturer in Bioengineering, and has served as an Adjunct Clinical Instructor of Cardiovascular Medicine, all at Stanford University. In these capacities, he mentors, advises, and teaches students and fellows about the biodesign process. Dr Kumar completed a Biodesign Innovation fellowship at Stanford, cardiology and cardiac electrophysiology fellowships at the University of California, San Francisco (UCSF), an internal medicine residency at Columbia University, and his medical and undergraduate education at Harvard University. He was also Chief Medical Officer and Vice-President of Biomedical Modeling Inc., a medical start-up company.

Lyn Denend is a Research Associate at Stanford University Graduate School of Business, where she has authored numerous case studies for use in graduate-level and executive education programs in areas such as strategic management, international business, supply chain management, healthcare, and biodesign innovation. Previously, Ms Denend was a Senior Manager in Cap Gemini Ernst & Young management consulting practice and Vice President of Operations for a start-up providing human resource services. She has an MBA from Duke University Fuqua School of Business and a BA in Communications from the University of California, Santa Barbara.

Thomas M. Krummel is Emile Holman Professor and Chair in the Department of Surgery, and Co-Director of the Stanford Biodesign Program, at Stanford University. He has been a pioneer and consistent innovator throughout his career, and has served in leadership positions in many of the important surgical societies including the American College of Surgeons, the American Pediatric Surgical Association, the American Surgical, the American Board of surgery, the American Board of Pediatric Surgery, and the American Board of Plastic Surgery. Over the last 14 years, Dr. Krummel has pioneered the application of technology to simulation-based surgical training and surgical robotics. For his work in this area, and developing a collaborative simulation-based surgical training system, he has received two Smithsonian Information Technology innovation Awards.

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Additional Information

Publisher
Cambridge University Press
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Published on
Sep 25, 2009
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Pages
779
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ISBN
9781139482264
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Language
English
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Genres
Medical / Physiology
Science / Life Sciences / Molecular Biology
Technology & Engineering / Biomedical
Technology & Engineering / Engineering (General)
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Content Protection
This content is DRM protected.
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th On behalf of the organizing committee of the 13 International Conference on Biomedical Engineering, I extend our w- mest welcome to you. This series of conference began in 1983 and is jointly organized by the YLL School of Medicine and Faculty of Engineering of the National University of Singapore and the Biomedical Engineering Society (Singapore). First of all, I want to thank Mr Lim Chuan Poh, Chairman A*STAR who kindly agreed to be our Guest of Honour to give th the Opening Address amidst his busy schedule. I am delighted to report that the 13 ICBME has more than 600 participants from 40 countries. We have received very high quality papers and inevitably we had to turndown some papers. We have invited very prominent speakers and each one is an authority in their field of expertise. I am grateful to each one of them for setting aside their valuable time to participate in this conference. For the first time, the Biomedical Engineering Society (USA) will be sponsoring two symposia, ie “Drug Delivery S- tems” and “Systems Biology and Computational Bioengineering”. I am thankful to Prof Tom Skalak for his leadership in this initiative. I would also like to acknowledge the contribution of Prof Takami Yamaguchi for organizing the NUS-Tohoku’s Global COE workshop within this conference. Thanks also to Prof Fritz Bodem for organizing the symposium, “Space Flight Bioengineering”. This year’s conference proceedings will be published by Springer as an IFMBE Proceedings Series.
Technology is essential to the delivery of health care but it is still only a tool that needs to be deployed wisely to ensure beneficial outcomes at reasonable costs. Among various categories of health technology, medical equipment has the unique distinction of requiring both high initial investments and costly maintenance during its entire useful life. This characteristic does not, however, imply that medical equipment is more costly than other categories, provided that it is managed properly. The foundation of a sound technology management process is the planning and acquisition of equipment, collectively called technology incorporation. This lecture presents a rational, strategic process for technology incorporation based on experience, some successful and many unsuccessful, accumulated in industrialized and developing countries over the last three decades. The planning step is focused on establishing a Technology Incorporation Plan (TIP) using data collected from an audit of existing technology, evaluating needs, impacts, costs, and benefits, and consolidating the information collected for decision making. The acquisition step implements TIP by selecting equipment based on technical, regulatory, financial, and supplier considerations, and procuring it using one of the multiple forms of purchasing or agreements with suppliers. This incorporation process is generic enough to be used, with suitable adaptations, for a wide variety of health organizations with different sizes and acuity levels, ranging from health clinics to community hospitals to major teaching hospitals and even to entire health systems. Such a broadly applicable process is possible because it is based on a conceptual framework composed of in-depth analysis of the basic principles that govern each stage of technology lifecycle. Using this incorporation process, successful TIPs have been created and implemented, thereby contributing to the improvement of healthcare services and limiting the associated expenses. Table of Contents: Introduction / Conceptual Framework / The Incorporation Process / Discussion / Conclusions
Introduction to Biomedical Engineering is a comprehensive survey text for biomedical engineering courses. It is the most widely adopted text across the BME course spectrum, valued by instructors and students alike for its authority, clarity and encyclopedic coverage in a single volume.

Biomedical engineers need to understand the wide range of topics that are covered in this text, including basic mathematical modeling; anatomy and physiology; electrical engineering, signal processing and instrumentation; biomechanics; biomaterials science and tissue engineering; and medical and engineering ethics.

Enderle and Bronzino tackle these core topics at a level appropriate for senior undergraduate students and graduate students who are majoring in BME, or studying it as a combined course with a related engineering, biology or life science, or medical/pre-medical course.

NEW: Each chapter in the 3rd Edition is revised and updated, with new chapters and materials on compartmental analysis, biochemical engineering, transport phenomena, physiological modeling and tissue engineering. Chapters on peripheral topics have been removed and made avaialblw online, including optics and computational cell biologyNEW: many new worked examples within chaptersNEW: more end of chapter exercises, homework problemsNEW: image files from the text available in PowerPoint format for adopting instructorsReaders benefit from the experience and expertise of two of the most internationally renowned BME educatorsInstructors benefit from a comprehensive teaching package including a fully worked solutions manual A complete introduction and survey of BMENEW: new chapters on compartmental analysis, biochemical engineering, and biomedical transport phenomenaNEW: revised and updated chapters throughout the book feature current research and developments in, for example biomaterials, tissue engineering, biosensors, physiological modeling, and biosignal processingNEW: more worked examples and end of chapter exercisesNEW: image files from the text available in PowerPoint format for adopting instructorsAs with prior editions, this third edition provides a historical look at the major developments across biomedical domains and covers the fundamental principles underlying biomedical engineering analysis, modeling, and designBonus chapters on the web include: Rehabilitation Engineering and Assistive Technology, Genomics and Bioinformatics, and Computational Cell Biology and Complexity
MUST WE AGE?
A long life in a healthy, vigorous, youthful body has always been one of humanity's greatest dreams. Recent progress in genetic manipulations and calorie-restricted diets in laboratory animals hold forth the promise that someday science will enable us to exert total control over our own biological aging.
Nearly all scientists who study the biology of aging agree that we will someday be able to substantially slow down the aging process, extending our productive, youthful lives. Dr. Aubrey de Grey is perhaps the most bullish of all such researchers. As has been reported in media outlets ranging from 60 Minutes to The New York Times, Dr. de Grey believes that the key biomedical technology required to eliminate aging-derived debilitation and death entirely—technology that would not only slow but periodically reverse age-related physiological decay, leaving us biologically young into an indefinite future—is now within reach.

In Ending Aging, Dr. de Grey and his research assistant Michael Rae describe the details of this biotechnology. They explain that the aging of the human body, just like the aging of man-made machines, results from an accumulation of various types of damage. As with man-made machines, this damage can periodically be repaired, leading to indefinite extension of the machine's fully functional lifetime, just as is routinely done with classic cars. We already know what types of damage accumulate in the human body, and we are moving rapidly toward the comprehensive development of technologies to remove that damage. By demystifying aging and its postponement for the nonspecialist reader, de Grey and Rae systematically dismantle the fatalist presumption that aging will forever defeat the efforts of medical science.

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