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E-raamat: Humanizing Healthcare - Human Factors for Medical Device Design

  • Formaat: PDF+DRM
  • Ilmumisaeg: 21-Feb-2021
  • Kirjastus: Springer Nature Switzerland AG
  • Keel: eng
  • ISBN-13: 9783030644338
  • Formaat - PDF+DRM
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  • Formaat: PDF+DRM
  • Ilmumisaeg: 21-Feb-2021
  • Kirjastus: Springer Nature Switzerland AG
  • Keel: eng
  • ISBN-13: 9783030644338

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This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented.

This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs.

  • Teaches readers to design medical devices that are safer, more effective, and less error prone;
  • Explains the role and responsibilities of regulatory agencies in medical device design;
  • Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.

1 Introduction
1(16)
1.1 Medical Error
1(5)
1.2 Medical Devices
6(2)
1.3 What Is Human Factors Engineering?
8(5)
Goals of Human Factors Engineering
9(2)
What Human Factors Engineering Is Not
11(1)
Benefits of Human Factors Engineering
12(1)
Resources
13(1)
References
14(3)
2 Qualitative Human Factors Research Methods
17(32)
2.1 Human-Centered Design
17(1)
2.2 Human Factors Research
18(1)
2.3 Reliability and Validity
18(2)
2.4 Selecting Research Participants
20(1)
2.5 Ethical Standards
20(1)
2.6 Literature Review
21(1)
2.7 Case Study
22(1)
2.8 Naturalistic Observation
22(2)
2.9 Design Ethnography
24(1)
2.10 Interviewing
24(4)
Structured Interview
24(1)
Semi-Structured Interview
25(1)
Unstructured Interviews
25(1)
Interview Questions
26(2)
Ensuring Interviews Are Productive
28(1)
2.11 Focus Groups
28(5)
In-Person Focus Groups (Synchronous, Co-Located)
29(1)
Remote (Online) Focus Groups (Synchronous, Distributed)
30(1)
Bulletin Board (Online) Focus Groups (Asynchronous, Distributed)
31(2)
2.12 Diary Studies
33(2)
2.13 Critical Incident Technique
35(1)
2.14 Participatory Design
35(2)
2.15 Contextual Inquiry
37(1)
2.16 Analyzing Qualitative Data
38(8)
Overview
38(2)
Task Analysis
40(2)
Swimlanes
42(1)
Journey Maps
43(1)
Scenarios
44(1)
User Profile
44(2)
Prototyping
46(1)
Resources
46(1)
References
46(3)
3 Quantitative Human Factors Research
49(20)
3.1 Questionnaires
49(3)
Likert Scale
50(1)
Semantic Differential
51(1)
Ranking
51(1)
Constant Sum
52(1)
3.2 Biometric Research
52(7)
Eye Tracking
53(2)
Facial Expression Analysis (FEA)
55(1)
Galvanic Skin Response (GSR)
56(2)
Electroencephalography (EEG)
58(1)
Electrocardiography (ECG)
58(1)
3.3 Correlational Research
59(1)
3.4 Experiments
60(4)
The Two-Condition Experimental Design
62(1)
Multiple Condition Design
62(1)
Factorial Design
63(1)
Between Subjects and Within Subjects Designs
63(1)
3.5 Analyzing Quantitative Data
64(2)
Central Tendency
65(1)
Dispersion
66(1)
Resources
66(1)
References
67(2)
4 Usability Evaluation
69(28)
4.1 Introduction
69(1)
4.2 Usability Inspection
70(5)
Heuristic Evaluation
70(4)
Cognitive Walkthrough
74(1)
4.3 Usability Testing
75(19)
What Is Usability Testing?
75(3)
Usability Study Tips and Pitfalls
78(1)
Categories of Usability Tests
79(1)
Components of a Usability Test
80(3)
What Is Measured in a Usability Test?
83(1)
How Many Participants Do You Need for a (Formative) Usability Test?
84(2)
Training Prior to Usability Testing
86(1)
Estimating Time Needs for a Usability Test
87(3)
The Iceberg Paradox
90(2)
Counterproductive Outlooks About Formative Usability Testing
92(2)
Resources
94(1)
References
95(2)
5 Visual Perception
97(38)
5.1 Information Processing
97(2)
5.2 Bottom-Up and Top-Down Processes
99(1)
5.3 Light Energy and the Eye
100(3)
5.4 Rods, Cones, and Color Perception
103(1)
5.5 Color Deficiency
104(1)
5.6 Contrast
105(1)
5.7 Image Size and Visual Angle
106(1)
5.8 Visual Accommodation
107(1)
5.9 Vision Problems
108(1)
5.10 Aging and Vision
109(1)
5.11 Central and Peripheral Vision
110(2)
5.12 How Visual Perception Works
112(1)
5.13 Attention's Role in Visual Perception
113(1)
5.14 Conspicuity
114(2)
5.15 Context
116(1)
5.16 Gestalt Psychology
117(7)
Figure-Ground
118(1)
Law of Pragnanz
119(1)
Proximity
119(1)
Continuity
120(1)
Closure
121(1)
Symmetry
122(1)
Similarity
122(1)
Common Region
122(1)
Familiarity
123(1)
5.17 Information Structure
124(2)
Visual Hierarchies
124(2)
5.18 Design Advice Based on Visual Perception
126(7)
Item Placement and Grouping
126(2)
Consistency
128(1)
Adhere to User Expectancies
129(1)
Redundant Coding
129(1)
Make Text Legible
129(3)
Contrast
132(1)
Make Sure Errors Capture the User's Attention
132(1)
Color
132(1)
Resources
133(1)
References
133(2)
6 Hearing
135(24)
6.1 Introduction
135(1)
6.2 What Is Sound?
135(10)
The Building Blocks of Sound
136(9)
6.3 How Do We Hear Sound?
145(3)
Outer Ear
145(1)
Middle Ear
146(1)
Inner Ear
146(2)
6.4 Sound Localization
148(3)
6.5 Hearing Impairments and Disorders
151(5)
Sensorineural Hearing Loss (SNHL)
151(3)
Conductive Hearing Loss (CHL)
154(1)
Auditory Processing Disorder (APD)
155(1)
Resources
156(1)
References
156(3)
7 Cognition
159(26)
7.1 Cognitive Resources
160(1)
7.2 Attention
161(4)
Focused Attention
162(1)
Multitasking
163(1)
Sustained Attention
164(1)
7.3 Memory
165(13)
Working Memory
165(5)
Long-Term Memory
170(1)
Contextual Memory, Recognition and Recall
170(2)
Structure of Long-Term Memory
172(1)
Declarative vs. Procedural Knowledge
172(1)
Organization of Semantic Memory
173(2)
Categorization
175(1)
Knowledge in the World vs. Knowledge in the Head
175(3)
7.4 Tips for Designers
178(3)
Resources
181(1)
References
182(3)
8 Use-Error
185(16)
8.1 Introduction
185(1)
8.2 What Is the Cause of All of These Use-Errors?
186(7)
Size and Complexity
187(1)
Emphasizing Technology Over the User
187(1)
Feature Creep
188(1)
Assuming Users Will Become Experts
188(1)
Relying on Training
189(1)
Underestimating Environmental Challenges
189(1)
Failing to Design for the "Worst Case Scenario"
189(1)
Failing to Expect Use-Errors
190(1)
Underestimating User Diversity
190(1)
Expecting People to Multitask
191(1)
Overestimating User Capabilities and Motivation
191(1)
Failing to Involve Users Early in Design
191(1)
Excessive Reliance on Thought Leaders
192(1)
Lack of Focus on Human Factors
192(1)
8.3 Slips
193(2)
Capture Slip
193(1)
Description Similarity Slip
194(1)
Mode Error Slip
194(1)
8.4 Lapses
195(1)
8.5 Mistakes
195(1)
8.6 Root Cause Analysis
196(1)
8.7 Hindsight Bias
196(1)
8.8 Designing for Error
197(2)
Swiss Cheese Model
197(1)
Constraints
198(1)
Undo
198(1)
Sensibility Checks
199(1)
8.9 Regulatory Considerations
199(1)
Resources
199(1)
References
199(2)
9 Human Factors Regulations for Medical Devices
201(26)
9.1 Human Factors Regulatory Guidelines
202(1)
9.2 Human Factors Process for Medical Devices
203(21)
Step 1 Identify Users, Environments, and Critical Tasks
203(5)
Step 2 Formative Research and Design Process
208(5)
Step 3 Validation/Summative Usability Testing
213(7)
How Many Use-Errors Will the FDA/Regulatory Agency Accept?
220(1)
Do We Have to Evaluate Tasks That Aren't Critical? If So, Should Noncritical Task Results Be Include in the Report?
220(1)
How Do We Define Critical Tasks?
221(1)
How Realistic Does the Simulated-Use Environment Need to Be?
221(1)
Can We Make Changes to the Device or Instructions After the Validation Usability Study?
222(1)
What Is the Purpose of Identifying Known Issues and How Do We Identify Them?
222(1)
What Characteristics Can Be Used to Define a "User Group"?
222(1)
Can Nurses and Physicians Be Included in One User Group?
223(1)
How Do You Recommend That We Incorporate User Research into Our Design Process? How Often and When Should We Conduct User Research? What Are the Best Strategies?
223(1)
Is There a Fast and Effective Way to Get Feedback on the Usability of My Device Without Having to Do an Actual Study with Users?
224(1)
Resources
224(1)
References
224(3)
10 Controls: Designing Physical and Digital Controls
227(44)
10.1 Introduction
227(1)
10.2 Control Coding Guidelines
227(11)
Color Coding
228(2)
Size Coding
230(2)
Location Coding
232(1)
Shape Coding
233(3)
Label Coding
236(1)
Mode of Operation
237(1)
10.3 Control Movement Considerations
238(4)
Directionality Considerations
238(1)
Control Travel Considerations
239(1)
Control Gain
240(2)
10.4 Control Size and Shape Considerations
242(6)
The Size of a Control(s) Should Be Comfortable, Accurate, and Consistent Use
242(1)
Surface Area Is King
242(2)
When Possible, Reduce, or Eliminate the Need for Fine Motor Control
244(1)
Finger-Operated Controls Should Support Multifinger Use
244(1)
Textures Help Improve Suboptimal Control Shapes
245(1)
Size and Shape Should Be Scaled to Match Effort, Duration of Use, and Accuracy Requirements
245(1)
Be Mindful of Control Resolution in Multistate Controls
246(1)
Avoid Sharp Edges Along Control Surfaces
247(1)
10.5 Control Feedback Considerations
248(7)
Visual Feedback
249(3)
Auditory Feedback
252(3)
10.6 Activation Force Considerations
255(2)
10.7 Control Placement Considerations
257(3)
Mind the User's Reach Envelope
257(1)
Dead Space Between Neighboring Controls Limit Accidental Activation
258(1)
Controls Placed Together Naturally Suggest a "Familial" Relationship
259(1)
10.8 Touchscreen Considerations
260(6)
Types of Touchscreens
261(2)
Size Considerations
263(3)
Resources
266(1)
References
266(5)
11 Displays
271(36)
11.1 Introduction to Displays
271(2)
11.2 Visual Displays
273(13)
Common Types of Visual Display Technologies
273(1)
Luminance Considerations
273(1)
Contrast
273(4)
Viewing Angle
277(1)
Hardware Considerations
278(1)
Color Considerations
279(1)
Resolution and Clarity Considerations
280(2)
Shape and Size
282(2)
Placement Considerations
284(2)
11.3 Auditory Displays and Alarms
286(16)
Overview of Auditory Displays and Alarms
286(1)
Fundamentals of Auditory Displays
287(15)
Resources
302(1)
References
303(4)
12 Human-Computer Interaction
307(26)
12.1 Introduction
307(1)
12.2 User Experience (UX)
308(1)
12.3 Design Principles
309(4)
Support Mental Models
309(1)
Allocate Tasks Wisely
310(1)
Consistency
311(1)
Minimize Memory Load
311(1)
Provide Informative Feedback
311(1)
Make Tasks Efficient
312(1)
Utilitarian/Minimalist Design
312(1)
Error Prevention and Error Handling
313(1)
12.4 Interaction Styles
313(4)
Form Fill-in
314(1)
Menus
315(1)
Direct Manipulation
316(1)
Command Line
316(1)
Gestures and Multitouch
316(1)
Dialog Boxes
317(1)
12.5 Information Architecture
317(4)
Depth vs. Breadth
318(1)
Serial Choice
319(1)
Branching
319(1)
Networked
319(2)
12.6 Screen Layout
321(4)
Grid
321(1)
Columns
322(1)
Blank Space
323(1)
Gutters, Margins, and Padding
323(1)
Grouping
324(1)
12.7 Legibility
325(1)
Text Size
325(1)
All Capitals
325(1)
Contrast
325(1)
Text Justification
326(1)
12.8 Color
326(5)
Color Guidelines
327(2)
Data Visualization and Graphics
329(1)
Table Design
329(1)
Small Displays
330(1)
Resources
331(1)
References
331(2)
13 Designing Instructions for Use(rs)
333(18)
13.1 Definitions
333(1)
13.2 Do We Need Instructions for Use?
333(1)
13.3 No Respect
334(2)
IFU as User Interface
334(1)
IFUs as Checking a Box
335(1)
IFUs as an Afterthought
335(1)
But Nobody Uses the IFU Anyway
335(1)
Rewriting IFU into Standard Operating Procedures (SOP)
336(1)
Ease of Use vs. Regulatory Standards
336(1)
13.4 Developing Instructions for Use(rs)
336(5)
Start Designing Early
337(1)
Develop User Profile
337(1)
Develop Environmental Profile
338(1)
Consider the User's Tasks
338(1)
Determine the Appropriate Format
338(1)
Identify Appropriate Authors
339(1)
Consider the Regulatory Requirements
339(2)
13.5 A Framework for Developing Good IFUs and a Model of IFU Use
341(5)
Finding Information
342(1)
Signal vs. Noise
342(1)
Organization
343(1)
Comprehending Information
344(1)
Cognitive Load Theory
344(1)
Chunking
344(1)
Meaning
345(1)
Familiarity
345(1)
Conciseness
346(1)
Facilitating Learning
346(1)
13.6 Applying Information
346(1)
Sequencing
347(1)
Help Readers Save Their Place
347(1)
Provide Feedback
347(1)
13.7 IFU Iteration and Evaluation
347(1)
Resources
348(1)
References
349(2)
14 Reusable Medical Devices, Reprocessing, and Design for Maintenance
351(16)
14.1 Introduction
351(2)
14.2 Reusable Medical Devices and Designing for Maintenance
353(2)
14.3 Reprocessing and Designing for Maintenance
355(4)
What Is Reprocessing?
355(3)
Why Is Reprocessing a Human Factors Engineering Issue?
358(1)
14.4 Designing Reusable Medical Devices to Optimize Reprocessing
359(4)
Interface 1 Reusable Medical Device
360(1)
Interface 2 Reprocessing Instructions for Use
361(1)
Interface 3 Training
362(1)
14.5 Conclusion
363(1)
Resources
363(1)
References
364(3)
15 Home Healthcare
367(20)
15.1 Introduction
367(3)
15.2 Challenges of Home Use Medical Device Design
370(1)
15.3 Users of Home-Use Devices
370(2)
15.4 Physical Size, Strength, and Stamina
372(1)
15.5 Dexterity, Flexibility, and Coordination
372(1)
15.6 Sensory Capabilities (Vision, Hearing, Tactile Sensitivity)
373(3)
15.7 Cognitive Abilities
376(1)
15.8 Literacy and Language Skills
377(1)
15.9 Emotions and Motivation
377(1)
15.10 Environment
378(1)
15.11 Design Considerations
379(2)
References
381(6)
Index 387
Russell J. Branaghan, PhD, has worked as a human factors engineer, research scientist, consultant and educator for over 30 years. He is President of Research Collective, a Human Factors and User Experience (UX) consulting firm and laboratory in Tempe, AZ. His work centers on healthcare human factors and user experience for leading companies in robotic surgery, cardiac rhythm management, diagnostic imaging, chronic disease management (e.g., hemophilia, diabetes), artificial organs, in vitro diagnostics, reprocessing, healthcare apps, wearables home health, and many others. Russ also serves as Associate Professor of Human Systems Engineering, Co-Director of the Master of Science in User Experience Program, and Director of the User Experience Laboratory (XLab) in the Ira A. Fulton Schools of Engineering at Arizona State University (ASU). He holds additional affiliations with the Kern Center for the Science of Healthcare Delivery at Mayo Clinic, the ASU-Mayo Center for Innovative Imaging,  and the Master of Product Design and Development program at Northwestern University. His research has been funded by The National Science Foundation, Mayo Clinic, The Veterans Health Administration, Federal Aviation Administration, Air Force Research Laboratory, Office of Naval Research, Motorola and others. His teaching has been recognized with awards from ASU and Northwestern. Prior to returning to academics and consulting, Russ held leadership positions in human factors and user experience at Hewlett Packard, IBM, Fitch and Lextant Corporation. An active researcher, Russ has edited one book and published over 100 journal articles, book chapters, and conference proceedings. He frequently serves as a reviewer for scientific and medical journals, and has sat on many editorial and industry boards, including the Human Factors and Ergonomics Society (HFES) Product Design Technical Group, the Organizing Committee for the HFES Healthcare Symposium, the Editorial Board of the Journal of Human Factors, the Advisory Board for Mayo Clinics Center for Innovation.  L. Bryant Foster, MS, is Vice President of Human Factors and User Experience at Research Collective, where he guides research, design, and evaluation efforts for medical device manufacturers, pharmaceutical companies, and others. An expert on regulatory issues in Human Factors, Bryant has guided surgical instruments, combination products, home-use devices, and OTC products to FDA clearance or approval. Further, he has designed, or contributed to the design of, usability labs for four separate companies. Prior to joining research collective, Bryant was a human factors consultant at Google-X. Bryant received his masters degree in Applied Psychology from Arizona State University, where he later served as Faculty Associate, Project Manager, and Chair of the Industry Advisory Board. He is an active and frequent speaker at conferences such as the Regulatory Affairs Professionals Society (RAPS) Convergence, and the Human Factors and Ergonomics Society (HFES) Healthcare Symposium. Bryant has contributed popular webinars and podcasts for AAMI and Greenlight Guru, and has authored book chapters on medical device human factors and human factors in device reprocessing. Bryant is also an active member of the AAMI committees on Human Factors Engineering and Combination Products. Emily A Hildebrand, PhD, is Director of Human Factors at Research Collective. She is a cognitive scientist specializing in human factors, with 10+ years of healthcare-specific experience. She leads usability, product design, and user-experience-related projects for Fortune 100 and Fortune 500 clients across a variety of fields. She also has extensive experience in product failure analysis and expert witness litigation support for medical devices. Emily has a Ph.D. in Applied Cognitive Science from Arizona State University. She has performed research on medical device usability and work processes at the Veterans Administration and Mayo Clinic. Her research culminated in guidance recommendations to FDA and AAMI for improving the usability of medical device interfaces. Emily is a frequent author and presenter on issues related to medical device design, human factors and medical device reprocessing. Joseph S. OBrian, MS, is a Senior Human Factors Scientist at Research Collective with over 5 years of experience conducting human factors research for major healthcare, automotive, and educational organizations. He is also Research Collectives in-house biometrics expert. Joe received a Masters degree in Human Systems Engineering from Arizona State University and was awarded the Engineering Schools Outstanding Graduate Student Award. He has published articles and presented conference papers on Human Factors, User Experience Design, design for accessibility, eye tracking, educational technology and educational ergonomics. He is a member of AAMI committees on home care and EMS environments, and has recorded popular AAMI webinars on Human Factors for Aging Adults, Recruiting Research Participants, and Writing Usability Test Reports.