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User Interface Requirements for Medical Devices: Driving Toward Safe, Effective, and Satisfying Products by Specification [Pehme köide]

, (UL-Wiklund, Concord, Massachusetts, USA), Illustrated by , (UL-Wiklund, Concord, Massachusetts, USA)
  • Formaat: Paperback / softback, 224 pages, kõrgus x laius: 234x156 mm, kaal: 700 g, 38 Tables, black and white; 3 Line drawings, black and white; 278 Halftones, color; 278 Illustrations, color; 3 Illustrations, black and white
  • Ilmumisaeg: 17-Nov-2021
  • Kirjastus: CRC Press
  • ISBN-10: 0367457474
  • ISBN-13: 9780367457471
  • Formaat: Paperback / softback, 224 pages, kõrgus x laius: 234x156 mm, kaal: 700 g, 38 Tables, black and white; 3 Line drawings, black and white; 278 Halftones, color; 278 Illustrations, color; 3 Illustrations, black and white
  • Ilmumisaeg: 17-Nov-2021
  • Kirjastus: CRC Press
  • ISBN-10: 0367457474
  • ISBN-13: 9780367457471

This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths. The book presents the strong connection between user interface requirements and risk management for medical devices and instructs readers how to develop specific requirements that are sufficiently comprehensive and detailed to produce good results – a user-friendly product that is likely to be used correctly. The book’s tutorial content is complemented by many real-world examples of user interface requirements, including ones pertaining to an inhaler, automated external defibrillator, medical robot, and mobile app that a patient might use to manage her diabetes. The book is intended for people representing a variety of product development disciplines who have responsibility for producing safe, effective, usable, and satisfying medical devices, including those who are studying or working in human factors engineering, psychology, mechanical engineering, biomedical engineering, systems engineering, software programming, technical writing, industrial design, graphic design, and regulatory affairs.



This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths.
Acknowledgments iv
About This Book xiii
About the Authors and Illustrator xvii
Chapter 1 What Is a User Interface?
1(12)
Hardware
1(2)
Software
3(2)
Labeling
5(1)
Soundscapes
6(1)
Aromas (Odors)
6(1)
Tastes
7(1)
Integrated Forms
8(1)
What Is Not a User Interface?
9(4)
Chapter 2 Role of User Interface Requirements in the Design Process
13(10)
Form Follows Function Follows User Need
15(8)
Chapter 3 Why We Need User Interface Requirements
23(6)
Satisfying Regulatory Requirements
23(2)
Satisfying Commercial Objectives
25(2)
Adding Structure to the Design Process
27(2)
Chapter 4 Common Pitfalls When Writing User Interface Requirements
29(8)
Lack of Data
30(1)
No Means of Enforcement
31(1)
Mutual Exclusivity
31(1)
Incomplete
32(1)
Too Specific
32(2)
Compound Requirements
34(1)
No Means to Verify
35(2)
Chapter 5 Writing Top-Quality User Interface Requirements
37(6)
Create an Outline
37(2)
Add Technical Anchors
39(1)
Maintain a Reasonable Scope
39(1)
Write Clearly and Concisely
39(1)
Add Illustrations
39(1)
Ensure Verifiability
40(1)
Example Improvements
40(3)
Chapter 6 Example User Interface Requirements
43(38)
About the Examples
43(2)
Stethoscope
45(3)
Anesthesia Workstation
48(2)
Auto-Injector
50(2)
Portable Patient Monitor
52(2)
Diabetes Management Application
54(2)
CT Scanner
56(2)
Cancer Detection Test Kit
58(2)
Dry Powder Inhaler
60(3)
Electronic Medical Record
63(2)
Robotic Arm and Software
65(2)
Automatic External Defibrillator
67(2)
Tonometer
69(3)
Hospital Bed
72(2)
Telehealth App
74(3)
Respirator
77(4)
Chapter 7 Conducting Research to Inform User Interface Requirements
81(8)
Learn about Users
82(2)
Learn about Use Environments
84(2)
Converting User Inputs into Requirements
86(3)
Chapter 8 Identifying Risks to be Mitigated through Design
89(18)
Determine Potential Use Errors
90(12)
Determine Risk
102(3)
List Use Errors Warranting Mitigation and Develop Requirements
105(2)
Chapter 9 Designing to Meet User Interface Requirements
107(8)
Conceptualize Design Solutions
107(4)
Iteratively Evaluate Potential Design Solutions
111(1)
Revise Design Solutions
112(3)
Chapter 10 Conducting Verification Activities
115(4)
Chapter 11 Conducting Validation Activities
119(10)
Design Verification versus Design Validation versus Human Factors Validation
119(3)
Human Factors Validation
122(2)
Design Validation
124(2)
Combining Validation Activities
126(3)
Chapter 12 Sources of User Interface Design Guidance
129(6)
Standards
129(3)
Human Factors and Ergonomics Society (HFES)
132(1)
U.S. Food and Drug Administration (FDA)
132(1)
Books
132(2)
Other Sources
134(1)
Websites
134(1)
Chapter 13 Our User Interface Design Tips
135(50)
Controls
135(10)
Displays
145(6)
Alarms
151(5)
Warnings
156(5)
Connectors and Connections
161(7)
Colors
168(4)
Cleaning
172(4)
Instructions
176(3)
Packages
179(6)
Chapter 14 Expanded Example for a Glucose Meter
185(16)
About the Expanded Example
185(1)
About Glucose Meters
186(2)
User Interface Requirements
188(13)
Index 201
Michael Wiklund, Erin Davis, Alexandria Trombley, and Jacqueline Edwards work together as part of ULs Human Factors Research & Design practice.