The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

1. GLOBAL GUIDE TO HUMAN FACTORS
AND USABILITY ENGINEERING
Bryant Foster
Sr. VP, Human Factors
Research Collective
August 31, 2022

2. ABOUT BRYANT
Co-founded Research Collective in 2013
Performed successful validation usability studies for more
than 50 medical devices including surgical instruments,
point-of-care devices, in vitro diagnostics, combination
products, Class III implants, home-use devices, OTC
products, and more.
Co-author of Humanizing Healthcare: Human Factors for
Medical Device Design (2021) and contributing author of
Design for Health: Applications of Human Factors (2020)
Instructor for Regulatory Affairs Professional Society
(Human Factors and Design Controls)

3. GLOBAL PLAYERS, HUMAN FACTORS GUIDELINES
Pretty much everywhere
IEC 62366-1:2015+A1:2020 Medical devices — Part 1: Application of usability
engineering to medical devices
United States FDA
Applying Human Factors and Usability Engineering to Medical Devices
United Kingdom MHRA
Guidance on applying human factors to medical devices
China NMPA
HFE guidelines still in draft form

4. GLOBAL DEFINITIONS OF TERMS IN 2022
Human Factors and Usability Engineering
The application of knowledge about human behavior, abilities, limitations, and other characteristics of
medical device users to the design of medical devices to achieve adequate usability of all parts of a user
interface. Human factors engineering and usability engineering are synonymous.
Usability Testing
Method used to evaluate a product’s usability, which usually employs simulated-use of the device in
question.
Validation/Summative Usability Testing
Usability testing conducted at the end of the device development process to provide objective evidence
that use-related residual risk has been reduced to acceptable levels.
Critical Task
A user task which, if performed incorrectly or not at all, would or could cause serious harm to the patient
or user, where harm is defined to include compromised medical care.

5. UPDATES IN GLOBAL REGULATIONS
IEC 62366-1:2015 Amendment 1 (2020)
• 22 issues presented to National Committee
• No fundamental changes to usability engineering process
A few highlights of revisions
• Manufacturers should follow the 2019 version of ISO 14971
• Introduction of the term “critical task” aligning with US FDA
• User groups are subsets of users who are differentiated by factors that may
influence their interaction with the medical device
• Mapping of normal vs. abnormal use
• Introduction of training as a third priority control measure
• Clarification of summative evaluation requirements related to participants, study
environment, and task success criteria
• Clarification that the purpose of the summative evaluation is to gather objective
evidence that the residual use-related risk is acceptable

6. ADDITIONAL UPDATES IN GLOBAL REGULATIONS
US FDA: Applying Human Factors and Usability Engineering to Medical Devices
• Published in 2016
• No updates
UK MHRA: Guidance on Applying Human Factors to Medical Devices
• Published in 2017
• Updated February 2021 to reflect the end of the (BREXIT) transition period. The
updates are primarily around the guidance applying to Great Britain, changes in
references to legislation and the introduction of the new UKCA mark.
China NMPA
• HFE Guideline not finalized
• 20 participants recommended in summative usability study
• Center for Medical Device Evaluation prefers report from state-owned lab

7. TRUST THE PROCESS

8. IDENTIFY DEVICE USERS
Identify the abilities and
limitations of the device’s users
so that the device may be
designed for those users.
Examine characteristics that
may indicate separate user
groups (Age, education,
condition, experience,
interaction with device, etc.)

9. IDENTIFY DEVICE USE ENVIRONMENTS
Identify the characteristics of the use
environment(s) that could impact the
safety, effectiveness, and usability of
the device.
• Home vs. clinical
• Lighting
• Noise(s)
• Temperature
• Distractions
• Cleanliness
• Space

10. IDENTIFY DEVICE USER INTERFACE
Identify the characteristics of the user interface that could impact the safety, effectiveness,
and usability of the device (device itself, packaging, training, labeling, instructional videos,
etc.)

11. IDENTIFY KNOWN USE ISSUES
Learn from the use-related shortcomings
of previous versions of the device or
similar devices of other manufacturers.
Primary research:
• Interviews with device users
• Observational research with device
users
• Interviews with trainers
Secondary research:
• Literature
• Internal complaint logs
• Databases

12. IDENTIFY CRITICAL TASKS
Identify which tasks have use-related risk and define their severity of potential harm.
Tasks with “serious” harm associated with misuse will require the manufacturer to provide
objective evidence through a validation usability study that use-related risk has been reduced to
acceptable levels.

13. CONDUCT FORMATIVE RESEARCH
• Identify elements of the user interface
to evaluate during development
• Select research method (i.e., usability
test, interviews, observations)
• Sample size (5-7 participants often
sufficient for formative usability studies)
• Important to remember that no
regulatory body regulates how these
are performed or documented
• Document the research effort and
resulting design improvements

14. VALIDATION USABILITY STUDY
Goal:
Obtain objective evidence that
the user interface can be used
safely
• Entire user interface is evaluated in its final form
• Performed in environment that closely resembles actual
environment in which the device is used
• Training is representative of real world and includes a learning
decay period
• All critical tasks are evaluated via simulated-use tasks or open-
ended comprehension questions
• Allow participants to interact with the device in as realistic a
manner as possible
• Record instances of misuse (use errors), difficulties, and close
calls and determine potential root causes
• 15 participants per user group, maybe

15. THE PROCESS, ONCE AGAIN

16. ELEMENTS OF HUMAN FACTORS REPORTS AND
THEIR PRIORITY

17. Elements of a human factors report
regardless of market
Priority given
by reviewers
Notes related to priority assignment
Description of intended users, uses,
environments, and training
Low Provide the components requested from the respective guideline and this should not be an
issue.
Description of the device user
interface
Low Describe the device/user interactions as requested in the guidelines.
Summary of known use-related issues Medium Do your homework. Reviewers want to see that you have taken into account things that can be
learned by a little digging.
Analysis and assignment of severity of
potential harm of misuse
High Every device task must be documented along with all potential ways the device could be
misused and the severity of potential harm related to misuse.
Summary of formative studies and
resulting design improvements
Low Provide a brief summary of how you evaluated the design along the way to develop something
that you can be proud of and will be safe in the hands of real people.
Tasks determined to be critical that
will be evaluated in
validation/summative study
High Very important! Reviewers will determine if the threshold you have set to determine critical tasks
is appropriate. Usually around the middle of the company’s severity scale.
Details of validation/summative
usability study (participants, study
environment, method of evaluating
critical tasks, training)
High Ensure the way the study is designed, including the characteristics of the study participants and
the way they simulate interaction with the device matches the description of intended users,
uses, environments, and training.
Detailed description of observed use
errors and difficulties on critical tasks
High This is what it’s all about. Everything above was done to get to this point. These objective results
should speak for themselves and should make it obvious to everyone whether or not the device
can be used safely.
Discussion of acceptability of results
(defense of reduction of use-related
residual risk to acceptable levels)
Medium This is your chance to tell the reviewer why they should accept the results of the
validation/summative study. They will determine if your rationale is appropriate based on the
actual results. Actions speak louder than words.
Conclusion Low Reviewers are more interested in the detailed results than the conclusion written by the
manufacturer.

18. QUESTIONS?
Bryant Foster
Sr. VP, Human Factors
bryant@research-collective.com
(480) 695-4292

19. RESOURCES
Russ Branaghan, Bryant Foster, Emily Hildebrand and
Joe O’Brian, from our team, recently co-authored a
book, Humanizing Healthcare
A comprehensive guide to human factors engineering
principles, guidelines, and design methods for medical
device design
Email: book@research-collective.com
The book can also be purchased from Amazon using
the following link:
https://www.amazon.com/Humanizing-Healthcare-
Factors-Medical-Device-dp-
3030644324/dp/3030644324/ref=mt_other?_encoding
=UTF8&me=&qid=

20. RESOURCES
AAMI TIR59: 2017 Integrating human factors into design controls
ANSI/AAMI/IEC 62366-1:2015/AMD1:2020 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
U.K. Medicines & Healthcare products Regulatory Agency, 2021, Guidance on applying human
factors and usability engineering to medical devices including drug-device combination products in
Great Britain
U.S. Food and Drug Administration, 2016, Guidance for Industry and FDA Staff: Applying Human
Factors and Usability Engineering to Medical Devices
https://www.emergobyul.com/resources/nmpa-expectations-applying-human-factors-engineering-
hfe-medical-devices
https://www.emergobyul.com/blog/2020/09/2020-amendments-iec-62366-implications-medical-
device-usability-engineering