Gary P. Pisano - The development factory: unlocking the potential of process innovation
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The development factory: unlocking the potential of process innovation
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Discusses both the theory and practice of process development. The book finds that process innovation, not just product innovation, can be the key to a competitive advantage. Its findings are based on an in-depth study of process development projects in a rapidly evolving, high-profile industry.
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The Development Factory : Unlocking the Potential of Process Innovation
author
:
Pisano, Gary P.
publisher
:
Harvard Business School Press
isbn10 | asin
:
0875846505
print isbn13
:
9780875846507
ebook isbn13
:
9780585223872
language
:
English
subject
Technological innovations--Economic aspects, Pharmaceutical industry--Technological innovations--Case studies, Chemical industry--Technological innovations--Case studies, Biotechnology industries--Technological innovations--Case studies, New products, Man
publication date
:
1997
lcc
:
HC79.T4P57 1997eb
ddc
:
338/.064
subject
:
Technological innovations--Economic aspects, Pharmaceutical industry--Technological innovations--Case studies, Chemical industry--Technological innovations--Case studies, Biotechnology industries--Technological innovations--Case studies, New products, Man
Page iii
The Development Factory
Unlocking the Potential of Process Innovation
Gary P Pisano
Page iv
Copyright 1997 by the President and Fellows of Harvard College
All rights reserved
Printed in the United States of America
01 00 99 98 97 5 4 3 2
Library of Congress Cataloging-in-Publication Data Pisano, Gary P The development factory : unlocking the potential of process innovation / Gary P Pisano. p. cm. Includes bibliographical references and index. ISBN 0-87584-650-5 (alk. paper) 1. Technological innovationsEconomic aspects. 2. Pharmaceutical industryTech nological innovationsCase studies. 3. Chemical industryTechnological innova tionsCase studies. 4. Biotechnology industriesTechnological innovationsCase studies. 5. New products. 6. Manufacturing processes. 7. Economic development. 8. Competition, International. I. Title. HC79.T4P57 1996 338'064dc20 96-4073 CIP
The paper used in this publication meets the requirements of the American National Standard for Permanence of Paper for Printed Library Materials Z39.49-1984
Page v
To my parents, who were the most important teachers during much of my own development.
Page vii
Contents
Preface
ix
Chapter 1 Introduction: Process Development as a Competitive Weapon
1
Chapter 2 A Framework for Process Development
25
Chapter 3 The Evolving Nature of Competition in Pharmaceuticals
51
Chapter 4 The Strategic Leverage of Process Development Capabilities
81
Chapter 5 The Anatomy of Process Development
117
Chapter 6 The Determinants of Performance: Development Lead Time and Cost
145
Chapter 7 Quality in the Development ProcessLeveraging Knowledge in Chemical Synthesis
179
Chapter 8 Learning across Projects in Biotechnology
203
Chapter 9 The Concepts in ActionCase Studies
233
Chapter 10 Conclusion and ImplicationsBeyond Pharmaceuticals
273
Page viii
Appendix Research Methodology
297
Notes
311
References
323
Index
333
About the Author
343
Page ix
Preface
The Development Factory is about managing process development in the pharmaceutical industry. Because some might be surprised that anyone would choose to write an entire book about process development (and equally astounded that it should focus on the pharmaceutical industry), let me offer a few words about the genesis of and motivation for this book.
During Autumn 1990 my colleague Steven Wheelwright and I began a project at a biotechnology firm renowned for its world-class capabilities in genetic engineering and biomedical research. Nevertheless, because of problems developing a viable manufacturing process, the company was struggling to get its first product through clinical trials and to market. Moreover, although the technical challenges of process development were significant, many of the company's problems seemed to be organizational in nature (miscommunication, lack of coordination, poor planning, and so forth). A number of concepts from manufacturing strategy and product development literature could clearly help the company with its more basic problems. But as we probed deeper into the company's problems over the course of several months it became evident that process development involved specific technical and managerial challenges that remained unaddressed by the existing bodies of literature. I thus began seeking research on process development that dealt with the specific issues faced by high-tech organizations. What I foundor, perhaps more accurately, what I did not findwas surprising.
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