The document provides an overview of the FDA's human factors guidance for medical device design. It discusses identifying device users and use environments, conducting formative usability testing during design, and validation usability testing on the final design. The goals are to demonstrate a device can be used safely and effectively by intended users. Post-market surveillance is also important to monitor for usability issues after a device is released. The three main steps in the human factors design process are identifying users and tasks, formative usability testing, and validation usability testing.

1. Demystifying the FDA’s Human
Factors Guidance
Bryant Foster, VP of Research & Design

2. About Bryant
Bryant Foster, MS
VP of Research & Design
• Leads human factors for medical device manufacturers,
pharmaceutical companies, automakers, and more.
• Wide range of products in healthcare:
o Surgical instruments
o Diagnostic equipment
o Combination products
o Infusion pumps
o Artificial organs
o Home-use devices
o Over-the-counter products
• Previous work: Google and Agilis Consulting Group
• Master’s degree in Human Factors from Arizona State
University

3. • Introduction to Human Factors
• Description of FDA’s Human Factors Guidelines
• Identification of device users, environments, critical tasks, etc.
• Formative usability evaluations
• Validation usability testing
• Post-market Usability Surveillance
Webinar Objectives

4. Formal Definition of Human Factors
Apply knowledge from ALL
human sciences
Improve the MATCH between
people & their products
Focus on HUMAN BEHAVIOR
and limitations

5. Good Design Is Not Easy

6. Nomenclature & Definitions
Human Factors & Ergonomics
The practice of designing products, systems, or processes to improve the
interaction between them and the people who use them
*In the United Stated, Human Factors more commonly used than Ergonomics

7. Nomenclature & Definitions
Human Factors & Ergonomics
The practice of designing products, systems, or processes to improve the
interaction between them and the people who use them
*In the United Stated, Human Factors more commonly used than Ergonomics
Usability testing
Method used to evaluate a product’s usability

8. Nomenclature & Definitions
Human Factors & Ergonomics
The practice of designing products, systems, or processes to improve the
interaction between them and the people who use them
*In the United Stated, Human Factors more commonly used than Ergonomics
Usability testing
Method used to evaluate a product’s usability
Formative Usability Testing
Purpose: Evaluate a product during the development process to ensure design
elements meet users’ expectations and identify opportunities for improvement

9. Nomenclature & Definitions
Human Factors & Ergonomics
The practice of designing products, systems, or processes to improve the
interaction between them and the people who use them
*In the United Stated, Human Factors more commonly used than Ergonomics
Usability testing
Method used to evaluate a product’s usability
Formative Usability Testing
Purpose: Evaluate a product during the development process to ensure design
elements meet users’ expectations and identify opportunities for improvement
Validation Usability Testing (Summative Testing)
Purpose: Confirm/Validate the product can be used safely and effectively by
representative users

10. Inspired by Murphy’s Law
• Anything that can go wrong, will go
wrong
• The least competent user
• The most complicated situation
Edward A. Murphy Jr.
Human Factors
Inspiration

11. Murphy’s Law in Action
Aviation

12. Murphy’s Law in Action
Medical:
Robin Rodgers

13. Murphy’s Law in Action
Medical:
Quaid Twins

14. Human Factors: The Numbers
Institue of Medicine report estimated
44,000 - 98,000
preventable hospital deaths annually.

15. Human Factors: The Numbers
Institue of Medicine report estimated
44,000 - 98,000
preventable hospital deaths annually.
That’s equivalent to a BOEING 747 crashing
once a day, for

16. FDA & Human Factors
2000

17. FDA & Human Factors
20112000

18. FDA & Human Factors
20112000 2016

19. FDA’s Human Factors Guidelines

20. Step One: Identify
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

21. Step 1: Identify Device Users
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

22. Step 1: Identify Device Users
• Who purchases the device?
• Who receives the device?
• Who unpacks the device?
• Who sets up the device?
• Who uses the device?
• Who cleans or reprocesses the device?
• Who disposes of the device?
IDENTIFY WHO:
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

23. Step 1: Identify Device Users
• Do they have any physical
limitations?
• Do they have any cognitive
limitations?
• What is their level of
education?
• Do they have any specialized
training?
• What is their of emotional
state when using the device?
CHARACTERISTICS:
• Who purchases the device?
• Who receives the device?
• Who unpacks the device?
• Who sets up the device?
• Who uses the device?
• Who cleans or reprocesses the device?
• Who disposes of the device?
IDENTIFY WHO:
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

24. Step 1: Identify User Interface Components
• Packaging
• Training
• Instructions for use (IFU)
• Labeling
• Buttons, knobs, levers, pedals, etc.
• Graphical user interface
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

25. Step 1: Identify Use Environment
• Where is the device used? In-Home? Clinical
Environment?
• What is the lighting like?
• What is the noise like?
• What is the flooring like?
• What is the temperature like?
• How many people are in the
environment?
• How much space do users have?
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

26. Step 1: Identify Known Use Related Hazards
• FDA’s Manufacturer and User Facility Device Experience (MAUDE) database
• FDA’s MedSun: Medical Product Safety Network
• CDRH Medical Device Recalls
• FDA Safety Communications
• ECRI’s Medical Device Safety Reports
• The Institute of Safe Medical Practices (ISMP’s) Medication Safety Alert Newsletters
• The Joint Commission’s Sentinel Events
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

27. Step 1: Identify CriticalTasks
• Identify all device tasks
• Set up, use, take down, storage, etc.
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

28. Step 1: Identify CriticalTasks
• Identify all device tasks
• Set up, use, take down, storage, etc.
• Identify critical tasks
• Harm to patient or user
• Delay in therapy
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

29. Step 1: Identify CriticalTasks
• Identify all device tasks
• Set up, use, take down, storage, etc.
• Identify critical tasks
• Harm to patient or user
• Delay in therapy
• Failure to perform a task correctly is called a use error
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

30. Step 1: Identify CriticalTasks
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

31. Step 1: Identify CriticalTasks
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

32. Step Two: Formative Usability Process
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

33. Step 2: Formative Usability Process
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

34. Step 2: Formative Usability Process
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

35. Step 2: Formative Usability Process
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

36. Step 2: Formative Usability Process
Formative Usability Process
• Evaluate interface elements in prototype form
• Individual components (instructions for use, handle shape,
information architecture, etc.)
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

37. Step 2: Formative Usability Process
Formative Usability Process
• Evaluate interface elements in prototype form
• Individual components (instructions for use, handle shape,
information architecture, etc.)
• Methods: Interview, observation, heuristic evaluation, simulated-use
• Follow “shut up” rule
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

38. Step 2: Formative Usability Process
Formative Usability Process
• Evaluate interface elements in prototype form
• Individual components (instructions for use, handle shape,
information architecture, etc.)
• Methods: Interview, observation, heuristic evaluation, simulated-use
• Follow “shut up” rule
• 5-7 participants uncover 85%+ of usability issues (Faulkner, 2003)
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

39. Step 2: Formative Usability Process
Formative Usability Process
• Evaluate interface elements in prototype form
• Individual components (instructions for use, handle shape,
information architecture, etc.)
• Methods: Interview, observation, heuristic evaluation, simulated-use
• Follow “shut up” rule
• 5-7 participants uncover 85%+ of usability issues (Faulkner, 2003)
• Early focus on critical tasks
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

40. Step 2: Formative Usability Process
Formative Usability Process
• Evaluate interface elements in prototype form
• Individual components (instructions for use, handle shape,
information architecture, etc.)
• Methods: Interview, observation, heuristic evaluation, simulated-use
• Follow “shut up” rule
• 5-7 participants uncover 85%+ of usability issues (Faulkner, 2003)
• Early focus on critical tasks
• Learn, learn, learn
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

41. Step 2: Formative Usability Process
Formative Usability Process
• Evaluate interface elements in prototype form
• Individual components (instructions for use, handle shape,
information architecture, etc.)
• Methods: Interview, observation, heuristic evaluation, simulated-use
• Follow “shut up” rule
• 5-7 participants uncover 85%+ of usability issues (Faulkner, 2003)
• Early focus on critical tasks
• Learn, learn, learn
• Perfect the study design before validation testing
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

42. Step 2: Formative Usability Process
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

43. Step Three: Validation Usability Testing
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

44. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Goal: Demonstrate the device can be used without serious use errors.
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

45. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Goal: Demonstrate the device can be used without serious use errors.
Characteristics:
• Final design of the device and labeling
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

46. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Goal: Demonstrate the device can be used without serious use errors.
Characteristics:
• Final design of the device and labeling
• All interface elements available
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

47. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Goal: Demonstrate the device can be used without serious use errors.
Characteristics:
• Final design of the device and labeling
• All interface elements available
• Realistic training provided (if applicable)
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

48. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Goal: Demonstrate the device can be used without serious use errors.
Characteristics:
• Final design of the device and labeling
• All interface elements available
• Realistic training provided (if applicable)
• 15 representative participants per user group
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

49. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Goal: Demonstrate the device can be used without serious use errors.
Characteristics:
• Final design of the device and labeling
• All interface elements available
• Realistic training provided (if applicable)
• 15 representative participants per user group
• Test all critical tasks
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

50. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Goal: Demonstrate the device can be used without serious use errors.
Characteristics:
• Final design of the device and labeling
• All interface elements available
• Realistic training provided (if applicable)
• 15 representative participants per user group
• Test all critical tasks
• Realistic simulated-use scenarios
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

51. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Goal: Demonstrate the device can be used without serious use errors.
Characteristics:
• Final design of the device and labeling
• All interface elements available
• Realistic training provided (if applicable)
• 15 representative participants per user group
• Test all critical tasks
• Realistic simulated-use scenarios
• No leading the witness (participant)
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

52. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Data collection
Observation of
participant performance
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

53. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Data collection
Observation of
participant performance
Knowledge task
comprehension
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

54. Step 3: Validation UsabilityTesting
VALIDATION
TESTING
Data collection
Observation of
participant performance
Knowledge task
comprehension
Qualitative
interview
responses
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

55. Step 3: Validation UsabilityTesting
Data analysis and report
Task
Use Errors (UE)
& Difficulties (D)
Observation &
Follow-Up
Potential root
Cause(s) of use
errors & difficulties
Clinical
Consquences
Potential
Harm
Possible
Risk Control
Redesign
needed?
Connect the
components
P12 broke the
connector(UE).
User could notdetermine
if the connection was
secure. He said he kept
tightening it until it
broke.
Connector does not
provide adequate feedback
when it is secure
Delayof
therapy
Seriousinjury
or death
Redesign the
connector to
provide a snap
sound and feel
when it is secure.
Yes
Startthe
therapy
P3, P5, P10pressed
the “Enter” button
rather than the
“Start” button (UE).
All three participants
presumed the “Enter”
button would start the
therapy. They self-
corrected after “Enter”
did not begin the therapy
and realized they needed
to select “Start”, which
they all did.
The GUI does not make
it clear that users should
press “Start” to begin the
therapy.
Delayof
therapy
Seriousinjury
or death
Make “Start”
more prominent
on the screen.
Allow users to
press “Enter” to
start the test.
No
IDENTIFY FORMATIVE USABILITY PROCESS VALIDATION TESTING

56. Beyond FDA Guidance: Post-Market Surveillance

57. Post-Market Usability Surveillance
VALIDATION
TESTING
Passing validation usability testing does not mean your device is perfect

58. Post-Market Usability Surveillance
VALIDATION
TESTING
Passing validation usability testing does not mean your device is perfect
Monitor critical incident reports for issues related to usability

59. Post-Market Usability Surveillance
VALIDATION
TESTING
Passing validation usability testing does not mean your device is perfect
Monitor critical incident reports for issues related to usability
Conduct field visits to observe the device in use

60. Post-Market Usability Surveillance
VALIDATION
TESTING
Passing validation usability testing does not mean your device is perfect
Monitor critical incident reports for issues related to usability
Conduct field visits to observe the device in use
Talk to actual users in the field

61. Post-Market Usability Surveillance
VALIDATION
TESTING
Passing validation usability testing does not mean your device is perfect
Monitor critical incident reports for issues related to usability
Conduct field visits to observe the device in use
Talk to actual users in the field
Create a design wish list for version 2 and beyond

62. Summary

63. Summary
VALIDATION
TESTING
1. Human factors is the study of the interaction between humans and
their products, services, environments, etc.
2. The goal of medical device human factors is to improve safety
3. FDA requires medical device manufacturers to demonstrate their
devices can be used safely and effectively through validation usability
test results
4. Surveillance of post-market issues will help ensure the device is safe
and desirable

64. Summary
The human factors process for medical device design can be broken into
three main steps:

65. Summary
The human factors process for medical device design can be broken into
three main steps:

66. Summary
The human factors process for medical device design can be broken into
three main steps:

67. Thank you
bryant@research-collective.com

68. References
VALIDATION
TESTINGAAMI HE75: 2009, Human factors engineering – Design of medical devices
AAMI TIR59: 2017 Integrating human factors into design controls
ANSI/AAMI HE75:2013 Human Factors Engineering – Design of Medical Devices
ANSI/AAMI/IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering
to medical devices
ANSI/AAMI/IEC 62366-2:2016 Medical devices – Part 2: Guidance on the application of
usability engineering to medical devices
Faulkner, L. (2003). Beyond the five-user assumption: Benefits of increased sample sizes in
usability testing. Behavior Research Methods, Instruments, and Computers, 35(3), 379-383
Nielsen, J. (1994b). Heuristic evaluation. In Nielsen, J., and Mack, R.L. (Eds.), Usability
Inspection Methods, John Wiley & Sons, New York, NY.
U.S. Food and Drug Administration, 2015, Guidance for Industry and FDA Staff: Reprocessing
Medical Devices in Health Care Settings: Validation Methods and Labeling
U.S. Food and Drug Administration, 2016, Guidance for Industry and FDA Staff: Applying
Human Factors and Usability Engineering to Medical Devices
Wiklund, M.E., Kendler, J. and Strochlic, A.Y. (2011). Usability Testing of Medical Devices.
Boca Raton, FL: Taylor & Francis/CRC Press.