This document provides an introduction to human factors and user experience (UX) for medical devices. It discusses Integrated Computer Solutions Inc. and UserWise Inc., two companies that provide UX and human factors engineering services for medical products. The document outlines the human factors process, which includes user research, risk analysis, iterative prototyping and usability testing to develop usable and safe medical devices that are compliant with regulations. It emphasizes applying human factors early in the design process to reduce costs and facilitate regulatory approval.

1. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Introduction to Human
Factors and UX
Lana Sneath, Human Factors Engineer at UserWise, Inc.
Milton Yarberry, Director of Medical Programs, ICS
1

2. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Who is UserWise?
2
UserWise works with medical product
companies to:
• Fulfill all steps of the Usability
Engineering Process
• Maintain compliance to applicable
standards and regulations:
• 2016 FDA/CDRH Human Factors
Guidance for Medical Devices
• IEC 62366:2007 and/or IEC
62366-1:2015
• IEC 60601-1-6
• ISO 14971.

3. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
To inspire usability engineering best practices within medical product companies
and to facilitate the development of usable medical products.
Company Mission
3

4. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
About ICS
4
● Founded in 1987, 120 employees
● HQ in Boston, offices in the Bay Area and Ottawa
● We provide:
○ UX design services
○ UI development
○ Custom software development services
○ IS0 13485-compliant development process
○ Linux and QNX platform and board support
○ Full end-to-end product realization
○ Qt training
● Our UX First approach means products we design are
developed on time and on budget
● We deliver 70+ projects annually for global brands

5. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Boston UX
● User experience (UX) design to help you with your
IEC 62366 compliant process
● Offering a full suite of user experience services:
○ Product vision and direction
○ UX design
○ Visual & motion design
○ Voice integration design
○ Usability research and testing

6. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
What is Human Factors Engineering,
and why is it important?
6

7. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Human Factors Engineering
7
The FDA defines Human Factors as “the application of knowledge about human
behavior, abilities, limitations…to the design of medical devices including…
• mechanical and software
driven interfaces,
• user documentation, and
• user training
…to enhance and demonstrate safe
and effective use.”

8. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Why is Human Factors Engineering Important?
8
Conservatively estimated, there are 210,000 preventable hospital
deaths annually in the United States.
J Patient Saf & Volume 9, Number 3, September 2013

9. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
American Combat Deaths by War
9

10. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Implement Human Factors Early in the Development Process
10
Cost WITH
Human Factors
Development phase (Time)
Investment Cost WITHOUT
Human Factors

11. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Implement Human Factors Early in the Development Process
11
Cost WITH
Human Factors
Pass validation testing at first
attempt
Iterative design - make
mistakes early and
often
Apply correct user
requirements, design
standards and
assumptions
Development phase (Time)
Investment Cost WITHOUT
Human Factors

12. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Implement Human Factors Early in the Development Process
12
Late realization
of mismatch
between user
expectations
and product
design
Applying last-minute
design changes
Expensive training and
support due to
ease-of-use issues
Apply long-term
support costs
Development phase (Time)
Investment
Unexpected validation
results – features need to
be modified & re-validated
Cost WITHOUT
Human Factors
Cost WITH
Human Factors

13. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Glucose Meter Recall
13
What error do you think people might make
with this display?

14. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
NicoletOne vEEG System (Software) by CareFusion - 2010 Recall
14
● Software led users to confuse the left and right sides of patient’s brain
● This depiction of brain hemispheres is inherently confusing. The person’s right
side is labelled ‘left’ and vice-versa

15. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
What are the Human Factors Guidance
and Regulations?
15

16. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Code of Federal Regulations (CFR) – Quality System Regulation
16

17. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
FDA Focus on Human Factors and Industry Response
17
Quality System
Regulations (1996)
1st
FDA Guidance,
Human Factors (2000)
Human Factors Team
formed at FDA’s Office
of Device Evaluation
(2007)
FDA boosts
organization’s Human
Factors Staff (2015)
ImprovedapplicationofHF
Time and Events
Human Factors/Usability for Medical Devices: An Historical Perspective, Ron Kaye Office of Device Evaluation, CDRH,
Food and Drug Administration, NIST Workshop on Usability and EHR Technology, June 7, 2011.

18. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
FDA Guidances
18

19. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
FDA Emergency Use Authorization (EUA) Guidance
19

20. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Human Factors Standards Outside of the US
20

21. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
What is the Human Factors Process?
21

22. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
The Human Factors Process
22
User Research Risk Analysis Iterative Prototyping &
Usability Testing
Usability Validation Human Factors
Submission

23. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
User Research
23
• Who will be the device Users?
• What are their characteristics, capabilities, training and background?
• How does the user profile impact the potential design?
Physicians EMTsSurgeons General Population Elderly Patients

24. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
User Research
24
• How is the device intended to be used?
• Who would be using the device?
• Where would the device be used (intended or
not)?
• What conditions is the device intended to be
used in?
Document in the:
• Use Specification,
• Risk Analysis, and/or
• Usability Study Protocol

25. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Known Use Problem Summary
25
Identifying Known Use Problems:
Use Problems
• 1st
Generation
Products
• Competitive
Products
• Similar Products
Complaints
MDRs
Literature
Internet Data
Use-Related
Risk
Analysis
User Interviews
Customer Service
RecallsSales
Representatives
For FDA and CE Submissions

26. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Use-Related Risk Analysis (Use FMEA)
26
Use-Related
Risk Analysis
Analytical &
Empirical Methods
to Identify Use
Errors
User Profiles
Use Environment

27. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Use Error Definitions
27
Use Error (IEC 62366-1): User action or lack of USER action while using the
MEDICAL DEVICE that leads to a different result than that intended by the
MANUFACTURER or expected by the USER.
Use Error (FDA): User action or lack of action that was different from that
expected by the manufacturer and caused a result that
(1) was different from the result expected by the user and
(2) was not caused solely by device failure and
(3) did or could result in harm

28. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Usability Testing
28
• Early-Stage Formative Studies on
mock-ups and prototypes
• Later-Stage End-to-End Formative
Studies to confirm readiness for
Validation
• Final Summative Usability/Human
Factors Validation Testing for
regulatory submissions

29. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
FDA Guidelines for Design of a Human Factors Validation Study
29
The human factors validation testing should be designed as
follows:
• Sample size of at least n=15 per user profile.
• Participants must be US Residents
• Participants must have representative training (or lack of
training), and appropriate training decay
• Participants must have no prior exposure to the product
• Participants must use the device independently and
naturally, without interference or influence from the facilitator
or moderator.
We typically recruit 18 participants per user profile to account for no
shows/disqualified participants

30. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Usability Testing Considerations During the COVID-19 Pandemic
30
Special modifications should be made to usability tests to
minimize the risk of transmission of the novel coronavirus:
● All participants and the study team should be equipped
with necessary PPE, including gloves and face masks
● The study articles, equipment, and surfaces in the study
room should be wiped down with disinfectant between
study sessions
● The study team should require participants to inform the
study team if they show symptoms prior to or within 2
weeks after the study session
● Remote moderation and observation is encouraged
● Government rules and regulations supersede the study
protocol

31. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
HFE to Accelerate Product Development
UX
Software
31

32. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Vignette – Safe vs. Easy (per FDA)
Human Factors
Applying knowledge of human abilities/limitations to device design
Usability User Experience
- Risk Mitigation
- Safe to use
- Learnable
- Efficient
- Delightful

33. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
● USERS AND ENVIRONMENTS Identify and
analyze intended users and expected use scenarios
and use environments
● HAZARDS AND CONSEQUENCES Identify
and explore potential device use‐ related hazards and
risks, and their potential clinical consequences
● IMPLEMENT CONTROLS Explore different
design alternatives
The Reasonableness of the
HF/UX Rationale
Define intended use,
users, environment
Identify use related
hazards
Estimate & prioritize use
error risk
Implement risk controls
Validate safety of use
Risk Acceptable?
New risks
Introduced?
Document Process
Monitor unanticipated
risks in post market
Yes
YesNo
No

34. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Using UX to Feed Regulatory Development
DEFINE & ANALYZE
RAPID SOFTWARE
PROTOTYPING
FORMATIVE STUDIES CONVERT PROTOTYPES
TO APPLICATION
DEVELOP BACK END
SOFTWARE
Begin Design Controls
21 CFR 820, ISO 13485 - Design Control and QMSIEC 62366 - Human Factors and Usability Standard

35. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Using UX to Feed Development
21 CFR 820, ISO 13485 - Design Control and QMS
DEFINE & ANALYZE
RAPID SOFTWARE
PROTOTYPING
IEC 62366 - Human Factors and Usability Standard
FORMATIVE STUDIES
CONVERT TO FRONT END
APPLICATION
FRAMEWORK
DEVELOP BACK END
SOFTWARE
● User research
● Functional analysis
● Task analysis
● Hazard analysis
● Design specifications
● User interface design with
Industry leading tools
● Quick, efficient product
realization
● UX Specifications
● High Fidelity Prototyping
● Early, inexpensive, design
modification
● GUI Navigation, GUI
Definition, Summative
Criteria
● Documented support for
FDA’s HFE/UE report
● Application Framework
● Built in software
architecture
● Framework Unit Tests
Product Requirements
Software and System
Specifications
Verification and
Validation
FDA Submission

36. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Vignette: UOUP for Legacy UI
SOUP = Software Of Unknown Provenance
UOUP = SOUP on a UI = UI without IEC 62366
1) Perform full usability processes on all parts of the UI (5.1-5.9), or
2) Post-market analysis and report , or
3) Rationale to not apply usability procedures to legacy UI

37. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Key Takeaways - How UX Design Streamlines Development
High Fidelity Prototypes
(pre-engineering)
Fewer late stage changes
UX Specifications
(Conditional UI behaviors “shall show
alerts until message received”)
Software Engineers
UI Definition
(Every UI, All Navigation)
Test Engineers
Define and Prototype
(IEC 62366 documentation)
HFE/UE Report for 510K

38. Integrated Computer Solutions Inc.
UserWise Inc.
www.ics.com
www.userwiseconsulting.com
Q&A