Presentation by Rebecca Moses, Human Factors for MedTech Ergonomics and Usability, for the mHealth Israel community: Human Factors for MedTech Ergonomics and Usability

1. Human Factors for MedTech
Ergonomics and Usability
Core Human Factors, Inc. • June 17, 2018
Presented by Rebecca Moses, Director
Rebecca@corehf.com
+972-3-763-0431
+1-610-668-2673

2. Agenda
Here’s what we’ll cover in the
next 40 minutes.
➔ Brief intro to Core Human Factors,
Inc.
➔ What is human factors
engineering/usability engineering
➔ What is the regulatory focus of
HFE/UE
➔ Guidances and standards
➔ Overview of how to execute HF
activities
➔ Q&A Time
2
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3. Core Human Factors, Inc. All rights reserved.

4. Our Team
4
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5. Some of the services we offer
5
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6. 6
What is human factors
engineering (HFE)/usability
engineering?
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7. Human Factors
Engineering
What it is...
1. It’s focused on use-related harm.*
But it has many other uses.
2. It’s an R&D activity.
It’s not a documentation activity.
3. It’s highly scalable.
Very few HFE programs are alike.
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8. Human Factors Engineering is the scientific discipline concerned with
the understanding of interactions among humans and other elements
of a system, and the profession that applies theory, principles, data and
methods to design in order to optimize human well-being and overall
system performance.1
Definition
8
1
Developed by the International Ergonomics Association (found at http://www.iea.cc/ergonomics/) and has been adopted by the Human Factors and Ergonomics Society.
8Core Human Factors, Inc. All rights reserved.

9. 9
PCA Components
© Core Human Factors, Inc. 2015
Cognition
Perception
Action
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10. Common Terms
Human Factors Engineering (HFE)
‘20s & ‘30s - workers
‘40s - safety and effectiveness
Usability Engineering (UE)
‘80s - satisfaction and desirability
Today: HFE = UE
User-centered Design
Intuitiveness
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Interaction Design
User Experience Design
Ergonomics
Ease of Use
Freedom from Error
Users, Uses, Use Env.
What makes something intuitive?
It’s about optimizing the relationship of the
users, uses, and use environment.
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11. Poor Usability is Unsafe
“Darn these hooves! I hit the wrong switch again! Who
designed these panels, racoons?”
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12. 1988 ANSI/AAMI HE48-1988, Human Factors for Medical Devices
1990 FDA Authorized to Regulate Design Control Process
1993 ANSI/AAMI HE48-1993, Human Factors for Medical Devices, Second Edition
1995 AAMI/FDA Human Factors Conference
1996 Design Controls finalized, included specific references to human factors
FDA Do it by Design: An Introduction to Human Factors in Medical Devices
1997 FDA DC Guidance, “HF...is implicit in paragraphs c, f, and g of 820.30”
1999 IOM’s “To Err is Human”, 98,000 deaths (US) from medical error
2000 CDRH Human Factors Guidance, techniques for reducing use-error risk
2001 ANSI/AAMI HE74, HF Design Process for Medical Devices
2006 IEC 60601-1-6, Usability Medical Devices
2007 IEC 62366, Application of HF to Medical Devices
FDA HF Team → ODE
2009 ANSI/AAMI HE75
2010 FDA HF Team increases in size
2011 CDRH Draft Guidance on HF
2014 IEC 62366, Legacy Amendment
2015 IEC 62366-1
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2016 CDRH Final Guidance on HF
OCP Draft Guidance on HF
CDRH Draft Guidance on Prioritization
2017 IEC 62366-2
TIR 59 Integrating HF into DC
MHRA Guidance (UK)
TBD Revised HE75
Regulatory History
1212
(30 yrs)
(23 yrs)
(21 yrs)
(18 yrs)
(11 yrs)
(7 yrs)
(3 yr)

13. Applying Human Factors
Engineering to Medical
Devices
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14. Regulatory focus
1414
Safety
Effectiveness
Desirability
Regulatory Focus
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15. Examples of many other uses
1. Reduced time to market
2. Improved sales
3. Simpler training
4. Reduced demand for customer support
5. Fewer returned products that are mistakenly deemed "defective"
6. Better treatment compliance rates
7. Increased utilization of available features
Adapted from AAMI/IEC TIR 62366-2: 2016
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16. Why?
1616
Why is it necessary to apply HF methodologies to ensure
safety and effectiveness?
Isn’t that the role of clinical research?
How is a clinical study different than an HF study?
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17. HF Study
● Is it safe?
● Is it effective?
● Assess use
Use is not controlled.
HF vs. Clinical
Clinical Study
● Is it safe?
● Is it effective?
● Assume use as intended
Use is controlled.
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Can you get HF data from a clinical study and clinical data from an HF study?
Good clinical data comes from clinical studies, not HF studies
Good HF data comes from HF studies, not clinical studies.
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18. Core Human Factors, Inc. All rights reserved.
Human factors validation Clinical study
● Training is realistic
● Labeling is final, intend-to-market
● Simulated use (typically), allows for:
○ Assessing dangerous scenarios
○ Compressing days/weeks/months of use
into a few hours (saving time & $)
● Objective observation, subjective
feedback, real-time data collection
● No intervention if use errors are observed
● Training is ideal (even “over trained”)
● Labeling is investigational
● Controlled real use
● Outcomes based
● Intervene if use errors are observed
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19. Guidances and Standards
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20. What is required?
US: Submit a Human Factors Engineering/Usability Engineering (HFE/UE)
report to FDA
EU: Prove conformance to ISO: 62366-1
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21. Core Human Factors, Inc. All rights reserved.
CDRH Guidance 2016:
Applying Human Factors
and Usability
Engineering to Medical
Devices
21

22. Table of Contents
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1. Introduction
2. Scope
3. Definitions
4. Overview
5. Device Users, Use Environments and User Interface
6. Preliminary Analysis and Evaluations
7. Elimination or Reduction of Use-Related Hazards
8. Human Factors Validation Testing
9. Documentation
10. Conclusions
11. Appendices
a. Appendix A: HFE/UE Report
b. Appendix B: Consideration for Determining Sample Sizes for Human Factors Validation
Testing
c. Appendix C: Analyzing Results of Human Factors Validation Testing
d. Appendix D: HFE/UE References
22Core Human Factors, Inc. All rights reserved. From CDRH Guidance 2016: Applying Human Factors and Usability Engineering to Medical Devices

23. Outline of HFE/UE Report
2323Core Human Factors, Inc. All rights reserved.
From CDRH Guidance 2016: Applying Human Factors and
Usability Engineering to Medical Devices

24. Core Human Factors, Inc. All rights reserved.
62366-1:2015 Medical
devices – Part 1:
Application of usability
engineering to medical
devices
24

25. 62366-1 summary
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Establish, document, and implement a Usability Engineering Process
● Prepare a Use Specification
● Identify user interface characteristics related to safety and potential use
errors
● Identify known or foreseeable Hazards and Hazardous Situations
● Identify the Hazard-Related Use Scenarios for summative evaluation
● User interface specification and a User Interface Evaluation plan
● User interface design, implementation, formative evaluation
● Summative evaluation
Document everything in the Usability Engineering File
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26. ISO 14971:
Application of risk
management to
medical devices
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27. Probability in human factors?
Probability of the occurrence of a use error.
● Difficult to determine
● Focus should be on the severity of the potential harm
Assume there is a 100% probability the use error will occur in real life. HF
studies are designed to catch 99% of issues, but are not meant to tell you
anything about how common each issue will be.
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28. Example usability path
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29. Specify Use
Intended Use, Users,
Environments &
Scenarios
Analyze Risk
Describe Use Errors
and Assess Use
Related Risks
Design Evaluate
HF Formative
Evaluations
Validate
HF Validation
(Summative Usability
Testing)
Develop, Optimize,
Implement & Inspect
UI Design
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30. Specify Use
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31. Intended use, users, environments, and scenarios
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32. USER GROUPS
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Training Gender Age Limitations Hand-dominance
Tasks
Preparation Administration Maintenance/Sterilization
Characteristics
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33. USER GROUPS: common distinctions
Perform different tasks:
● Doctors prescribe the product, pharmacists prepare the product, nurses
administer the product
● HCPs or techs set up the device, but patients use it for treatment
● OR techs use the product outside the sterile field, surgeons within
Have different characteristics (even if they perform the same tasks):
● HCPs vs. lay users (patients and caregivers)
● Experienced vs. inexperienced patients or caregivers
● Adult vs. pediatric patients
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34. Analyze Risk
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35. Describe use errors and assess use-related risk
Use-related risk analysis suggested columns (task based)
● Task
● Perception/Cognition/Action
● Potential use error
● Hazard resulting from use error
● Harm
● Severity
● Criticality
● Risk Control Measures
● Evidence of risk control effectiveness
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36. Design
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37. Develop, Optimize, Implement & Inspect UI
Design
● Changes to mitigate risk:
○ Inherent safety by design
○ Protective measures in the medical device itself or in
the manufacturing process
○ Information for safety
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38. Evaluate
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39. 3. Recruit Participants
4. Setup Test Environment
Usability Testing
1. Choose a Sample
39
2. Create Protocol
5. Conduct & Record
6. Organize & Analyze Data
7. Create Report
8. Refine the Design
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40. Validate
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41. FDA validation testing
The human factors validation testing should be designed as follows:
● The test participants represent the intended (actual) users of the device.
● All critical tasks are performed during the test.
● The device user interface represents the final design.
● The test conditions are sufficiently realistic to represent actual conditions
of use. (CDRH guidance, February 2016)
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42. How does validation testing differ from
formative testing?
● Sample size (15 per user group)
● Only critical tasks
● Final user interface - including packaging, labeling, training
● Only realistic, natural-use scenarios
○ No forced-IFU
○ No asking participants to “think out loud” if they would not do so in real life
○ No interrupting
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43. Core Human Factors, Inc. All rights reserved.
How to Pass
HF Validation
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1. Know Your 3 “U”s
2. Start Early
3. Test Early
4. Test Often
5. Design for Safety
6. Engage Experts
7. Focus on Results

44. Summative testing (62366)
An FDA validation study will suffice as a summative study for 62366
conformance.
However, it is possible that a summative study will not meet FDA requirements:
Human factors validation testing is sometimes referred to as “summative usability
testing.” However, summative usability testing can be defined differently and some
definitions omit essential components of human factors validation testing as
described in this guidance document. (CDRH guidance, February 2016)
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45. Questions?
45
+1-610-668-CORE (2673)
+972-3-763-0431
www.corehf.co.il | info@corehf.co.il