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Designing Usability into Medical Products
Copyright © 2005 CRC Press LLC
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Library of Congress Cataloging-in-Publication Data
Designing usability into medical products / edited by Michael E. Wiklund, Stephen B. Wilcox.
p. cm.
Includes bibliographical references and index.
ISBN 0-8493-2843-8 (alk. paper)
1. Medical instruments and apparatus--Design and construction. 2. Design. 3. New
products--Evaluation. 4. Medical instruments and apparatus--Quality control. I. Wiklund,
Michael E. II. Wilcox, Stephen B.
R856.D473 2004
610'.28--dc22
2004048932
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International Standard Book Number 0-8493-2843-8
Library of Congress Card Number 2004048932
Printed in the United States of America 1 2 3 4 5 6 7 8 9 0
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Dedication
To Amy and my children, Ben, Ali, and Tom
M.W.
To Stephanie
S.W.
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Contents
About This Book
About the Authors
Acknowledgments
Foreword
General Principles and Processes
1. The Rising Bar — Medical Product Design Excellence
Michael E. Wiklund
2. The Role of Industrial Design and Human Engineering
in the Design of Software-Driven Medical Products
Stephen B. Wilcox
3. Is Your Human Factors Program Ready for FDA Scrutiny?
Michael E. Wiklund
4. Human Factors Roundtable
5. User-Centered Medical Product Development and the
Problem of Egocentrism
Stephen B. Wilcox
6. Ethnographic Methods for New Product Development
Stephen B. Wilcox
7. Time-Lapse Video Offers More Information in Less Time
Stephen B. Wilcox
8. Finding and Using Data Regarding the Shape and Size
of the User’s Body
Stephen B. Wilcox
9. Can You Trust What People Say?
Stephen B. Wilcox
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10. Eight Ways to Kill Innovation
Stephen B. Wilcox
11. Developing Testable Product Simulations:
Speed Is of the Essence
Stephen B. Wilcox
12. Patient Simulators Breathe Life into Product Testing
Michael E. Wiklund
13. Return of the Renaissance Person: A Valuable Contributor
to Medical Product Development
Stephen B. Wilcox
14. Patenting Software User Interfaces
Michael E. Wiklund
Design Methods and Guidance
15. The Vision Statement for Product Design —
In Your Mind’s Eye
Michael E. Wiklund
16. Making Medical Device Interfaces More User-Friendly
Michael E. Wiklund
17. Controlling Complexity
Michael E. Wiklund
18. Eleven Keys to Design Error-Resistant
Medical Devices
Michael E. Wiklund
19. Designing a Global User Interface1
Michael E. Wiklund
20. Why Choose Color Displays?
Michael E. Wiklund
21. Intuitive Design: Removing Obstacles
Also Increases Appeal
Michael E. Wiklund
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22. Medical Devices That Talk
Michael E. Wiklund
23. Home Healthcare: Applying Inclusive Design Principles
to Medical Devices
Stephen B. Wilcox
24. Designing Usable Auditory Signals
Stephen B. Wilcox
25. Medical Device User Manuals:
Shifting toward Computerization
Michael E. Wiklund
Corporate Human Factors Programs
26. User-Centered Design at Abbott Laboratories
Edmond W. Israelski and William H. Muto
27. User-Centered Design at Ethicon Endo-Surgery
Larry Spreckelmeier
Product Design Case Studies
28. Case Study: Personal Hemodialysis System
29. Case Study: Patient Monitor
30. Case Study: Development of a Contrast Medium Injector
System for CT Scanning
31. Case Study: Remotely Controlled Defibrillator
Resources
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About This Book
This book is co-authored by good friends who are also arch competitors.
Both Michael and Steve lead human factors research and design practices
— one in Concord, MA, the other in Philadelphia, PA — focused on medical
technology development. On several occasions, their firms have bid on the
same projects. Fortunately, each firm has won its share of bids, so there have
been no hard feelings. In fact, the competition, as well as the authors’ par-
ticipation in special professional activities, has generated mutual admiration.
Michael and Steve have served together as judges for the Medical Design
Excellence Awards. They have authored separate portions of a human factors
design standard published by the Association for the Advancement of Med-
ical Instrumentation. And they have both led professional interest sections
of the Industrial Designers Society of America. Over the course of several
committee meetings and dinners, Michael and Steve have enjoyed compar-
ing notes about managing consulting practices and the challenges of working
in the medical technology industry.
The idea of writing a book together did not surface until one summer day
in New York City. The authors were in the city to attend a Medical Design
Excellence Awards ceremony, but not before an early lunch at the Carnegie
Deli (see Figure). Steve ordered a monster-sized hot pastrami with a side of
bacon. Michael ordered an omelet (no cheese) and a bottomless cup of coffee
(decaffeinated). When the waitress delivered the food, she commented, “You
guys look like the types to co-author a book about medical technology
design.” Imagine that!
OK. The waitress was not our muse. Actually, the authors were discussing
— between mouthfuls — how much they enjoyed writing articles about
medical product development and how much fun it would be to collaborate.
And that is when one of the authors (identity intentionally withheld) said,
“We could get filthy rich writing a nonfictional account about the design of
user-friendly infusion pumps, defibrillators, and patient monitors!”
So, this is the book conceived in a New York deli. Many of the chapters
first appeared as articles in Medical Device & Diagnostic Indus,t rAyppliance
Manufacture,r and Innovatio.n As a result, each chapter stands well on its own,
and readers should feel free to jump to the chapters that interest them. Being
hardworking and responsible individuals, the authors updated each chapter
to reflect their current thinking and the latest facts. They also added several
new illustrations to clarify the written material and present examples of good
design. For people who like shortcuts, the authors have even added a list of
key points to the end of each chapter.
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Carnegie Delicatessen Restaurant in New York City. Source: www.asahi-net.or.jp/~rn8t-nkmr/
family/NY/carnegie-deli.jpg
The early chapters discuss broad concepts pertaining to making medical
devices safe and effective by involving users in the design process. The
middle chapters discuss more specific design and evaluation methods and
tools. The later chapters present case studies of user-friendly medical tech-
nologies and corporate human factors programs, as well as related resources
for medical design professionals.
The authors hope that readers will draw useful guidance from the book
on an as-needed basis. They see limited value in reading the book chapters
in a particular order. Rather, they encourage people to take what they need
from the book when they need it. One reader may seek advice about con-
ducting ethnographic research. Another may seek guidance on designing
medical device alarms. Yet another may seek guidance on designing an
intuitive user interface. Meanwhile, reading the whole book will give the
reader a comprehensive understanding of designing medical devices in a
manner that places users’ needs front and center — not a bad outcome.
Michael and Steve do not suggest taking their advice as the gospel, par-
ticularly because they do not agree on every technical issue. Michael is a
human factors engineer and Steve is a psychologist, by training. They do
practically the same thing professionally, but have very different perspec-
tives. Enough said? The studious reader will note areas of minor disagree-
ment in the authors’ preferred approaches to user research. This divergence
may be the book’s greatest strength or weakness. But either way, the authors’
sometimes divergent views reflect the fact that user-centered design is part
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science and part art. The authors present some information as fact. For
example, government requirements to conduct human factors studies in the
course of medical device design are fact. The rest of the authors’ guidance
draws upon their professional opinions, making the guidance subject to
debate.
Michael and Steve will continue to debate the fine points and encourage
readers to draw their own conclusions.
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About the Authors
Michael E. Wiklund, P.E.
Michael has been a practicing human factors
engineer for 22 years and counting. He loves
his profession because it enables him to work
closely with people as well as up-and-coming,
exciting technology. He was originally drawn
to the medical industry because it affords the
opportunity to create designs that make a dif-
ference in people’s lives — making people
safer, healthier, and more comfortable.
Michael received his master’s degree in engi-
neering design (human factors) from Tufts
University, where he is now an adjunct asso-
ciate professor. His graduate course, Applied
Software User Interface Design, has evolved
over more than a decade to keep pace with changing technology and a
growing job market for engineers and designers, with a sympathetic attitude
toward the needs and preferences of real people.
Michael has spent the majority of his career as a consultant specializing
in user-interface research, design, and usability testing. In addition to contrib-
uting individually to medical product development projects, he has built a large
consulting practice and helped other organizations build their own internal
consulting groups. Following a long tenure with American Institutes for
Research, he recently launched his own consulting practice.
His recent projects have involved the development of advanced technol-
ogies, such as patient monitors, dialysis machines, infusion pumps, and
medical information management systems. However, his professional inter-
ests extend beyond medical product development to include consumer and
household products, aviation and automotive applications, and business and
personal software applications (including Web sites). Accordingly, he has
recently worked on wireless communication devices, commerce and health-
related Web sites, and even garden tractors. His medical clients have ranged
from large, multinational companies with broad product lines to startup
companies developing novel technologies, each interested in improving the
quality of interaction between their products and customers.
This is Michael’s third major publication. Previous publications include
Medical Device and Ergonomic Design: Usability Engineering and Ergonoamndics
Usability in Practi.c eHe has also written more than 50 technical articles for
assorted design and technology publications. Someday, he would like to try
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