Integration OF Human Factors Engineering with Design Controls
AAMI Human Factors October
1. medical-device-regulations.com
Register online today at:
6th - 8th
October 2015
Castleknock Hotel
Dublin
Ireland
Highlights:
• New guidance on preliminary analysis and formative testing
• Learn the critical data approving authorities seek when assessing submissions
• Participate in valuable walk-through ‘real world’ and ‘simulated’ exercises
• Gain insights into meeting and surpassing HE-74, HE-75 and IEC-62366 standards
• Open Q&A sessions with FDA representatives for medical and combination devices
World-class faculty
Led by Dr. Robert A. North and Dr. Edmond Israelski. Uniquely, this course
includes Q&A sessions on achieving and accelerating pre-market clearances
with Ronald D. Kaye, leader of the Human Factors Pre-Market Evaluation Team
within the FDA’s Office of Device Evaluation (ODE).
World-class course
The most comprehensive Human Factors for Medical Devices
course in the world, and this is the only open registration AAMI
Usability Engineering course delivered in Europe!
Hosted by: Sponsored by:
Human Factors for
Medical Devices
Concepts, science and practical methods for
bringing devices to market more efficiently
2. Covering what’s acceptable data for
submission to the FDA
Discussing the device submissions,
approvals and validation process
Sharing insights into common
submission errors and deficiencies
We are also hoping that a
representative from the Center for
Drug Evaluation and Research (CDER)
will also join one of the Q&A sessions
Gain the most up-to-date, comprehensive
overview to Human Factors for medical
devices...
AAMI are delighted to be invited to deliver our
Advanced Human Factors for Medical Devices in
Europe for the first time*
Helping you understand the changes taking place within the
Human Factors landscape, how to shorten your device approval
times and how to reduce application deficiencies, this well
established 3 day course has been designed to deliver real world
and practical techniques that can be implemented into your
current device development process.
As practitioners connected to leading international standards
bodies, we understand the challenge of creating and submitting
opportunities for new / improved medical devices. Through
discussions, formal teaching and a practical combination of
situational analyses; hands on case study exercises and industry
examples, we’ll cover the tools and best practice techniques that
are driving modern usability engineering, and the assessment
processes that govern them.
Join us in October when, together, we’ll join the dots that connect
the concepts, science, processes and applications required to
bring new devices to market efficiently. You’ll leave with new
perspectives on all major aspects of integrating, applying,
analysing and testing human factors in your device development
process and a foundation for bringing what you’ve learnt back
into your organisation.
Unlike any other course of its type,
and through the involvement of Ron
Kaye, the leader of the Human Factors
Pre-Market Evaluation Team within
the FDA’s Office of Device Evaluation
(ODE), we’ll cover what’s required
(to do things right) when creating
and submitting medical device
applications to the FDA for pre-market
approval.
Recognised across the world as the
benchmark accreditation standard for
Human Factors in Medical Devices,
this is the only event in Europe where
you’ll get direct communication with
representation from the FDA.
Providing a window into the ODE's
current thinking and to make the work
of reviewing and understanding a
sponsor's efforts much easier, and
thus, quicker to approve, Ron will lead
two interactive Q&A’s:
A message from
the course faculty
Ronald D. Kaye leader of
the Human Factors Pre-Market
Evaluation Team within the FDA’s
Office of Device Evaluation (ODE)
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Fig. 1: Learn new ways to manage the three major components of the device-user system:
(1) device users, (2) device use environments and (3) device user interfaces.
Two Q&A sessions
You’ll learn what needs to be done and
how to go about it, in the most efficient
and focused ways...
Video
Conference
* This is the first AAMI open registration course ever to take
place in Europe. The Course is well established in USA and
has been delivered in Europe as private in-company training.
3. Programme
Day 1
09.00
09.30
09.45
11.00
11.45
12.00
13.15
14.00
16.30
17.15
18.15
19.30
NOTE: Day 1 schedule allows delegates to
arrive on an early morning flight
Registration
Open and welcome
SESSION I: INTRODUCTION
& OVERVIEW
During this session we will
preview the course modules
related to key objectives in
applying Human Factors (HF) in
medical device development. You
will learn how to:
Identify the scope of Human Factors
/ Usability Engineering and its role in
medical device development
Relate Human Factors activities to the
medical device Design Controls Process
of the Quality System Regulation
SESSION II: FDA/CDRH*
PRE-MARKET REVIEW
PERSPECTIVE
During this session, you will learn
how to :
Relate the FDA perspective on safety
and use error avoidance to user interface
design of medical devices.
Identify essential elements of successful
FDA submissions regarding human factors
and use error analysis.
Identify current industry Human Factors
trends seen by the FDA in new device
submissions.
*Centre for Devices and Radiological Health
Morning refreshments and
networking break
SESSION III: PRELIMINARY
ANALYSES FOR PRE-MARKET
APPROVAL
During this session participants
will gain a sample format for the
collection and documentation
of the user requirements into
a single table useful for device
submissions.
You will learn:
The key analysis methods and documents
for conducting Human Factors Preliminary
Analyses requirements of a medical
device in the early stages of development.
The relationship of these methods to
overall device Risk Management and FDA
expectations for pre-market approval.
How to analyse the user as a system
component.
Networking lunch
SESSION III: Cont.
Workshop Activity:
Participants will work in groups
on a Perceptual, Cognitive and
Action model (PCA) activity.
Followed by
Risks in the interaction with medical
devices
During this session there will be
a 15 minute refreshments and
networking break
SESSION IV: FORMATIVE
EVALUATION AND DESIGN
MODIFICATION PART I
During this session you will learn:
Formative Evaluation methods that are
appropriate for iterative modification of
device user interfaces early in Design
Concept and Design Input stages
Q&A WITH RON KAYE (FDA)
Video Conference. Ron shares his
experiences and insights related to the
FDA’s device approvals process
Networking drinks reception
Delegates get to share personal
experiences and meet the event
hosts over complimentary
networking drinks.
Delegates are free to continue
networking or make their own
arrangements for food etc.
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ABOUT THE COURSE
Improve your NPD process and
streamline your device approval
Human Factors continues to
become ever more important
to the design, safety,
effectiveness and successful
application of medical
devices.
This practical 3 day course offers
participants a comprehensive way
to integrate methods, analysis and
testing into your product development
process. It covers a practitioners
perspective into:
The Quality System Regulation
Design Controls process.
Regulatory bodies placing a
growing emphasis on pre-market
clearance and submission reviews.
New guidance that extends the
“removal of risk for safety” into
"optimisation of the user interface”
and “improving the overall efficacy
of interaction”.
Looking in detail at applying human
factors methods during device design,
development, validation of use,
manufacture and pre / post-market
delivery, we cover everything from
user models and task analysis, to the
anatomy of use errors and how task
analysis forms the basis for planning
human factors efforts.
The course also includes a ‘critical
elements’ review of human factors
standards – such as IEC-62366 and
HE-74 etc, and best practice process
methodologies – for contextual
inquiries, heuristic evaluations as well
as formative and summative studies.
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Event Website
www.medical-device-regulations.com
@AAMI_TrainingEU
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4. SAVE TIME!
Quick Registration
Contact Victoria on:
+44 (0)1325 526 000
08.00
08.30
11.00
11.15
12.15
13.15
15.00
15.15
16.30
18.00
19.00
Tea, coffee and refreshments
SESSION IV: FORMATIVE
EVALUATION AND DESIGN
MODIFICATION PART II
During this session you will learn:
How to relate the methods covered in Part
I of this session to overall use-related risk
identification and management.
Workshop Activity:
Participants will work on a
formative evaluation and design
modification group activity.
Morning refreshments and
networking break
SESSION V: HUMAN
FACTORS VALIDATION
TESTING
During this session we will
discuss the FDA pre-market
approval requirements, focusing
on:
Expectations for comprehensive and
adequate HF/Usability validation test.
Steps in planning and executing
HF/Usability validation studies.
Networking lunch
SESSION VI: HF/USABILITY
REPORT
During this session we will cover:
Any questions arising from Session V
Office of Device Evaluation (ODE)
reviewer expectations for pre-market
review of HF/Usability in new device
submissions
Supports your development of the
HF/Usability section of your new device
submission
Afternoon refreshments and
networking break
SESSION VII: CASE STUDY
During this session we will
examine a real life example of
employing human factors around
a drug delivery device.
Workshop Activity:
Participants will work on
an activity centred on the
development of a combination
product Auto-Injector drug
injection device, planning and
conducting Human Factors for:
Identification of actions and action
planning
Identify characteristics of a good HF plan
Discuss the creation of a HF plan
Given a scenario, evaluate and make
suggestions for improvements
Discuss findings with rest of the group
Q&A WITH FDA
Video Conference with a representative
from the FDA's Center for Drug Evaluation
and Research
Delegates are free to make their
own arrangements for food etc.
All delegates will receive an invite
to the Gala Dinner
The curriculum and
discussions were very
valuable to me. I am
already seeing the positive
impact on my ability to
perform my job
Attendee ref : 10517 . June 2013 course
Great to hear examples
of how the FDA evaluates
HFE submissions from
the people who actually
evaluate those submissions
Attendee ref : 10482 . June 2013 course
Image : Toshiba Medical Systems Europe
Programme
Day 2
Based on AAMI feedback from an audience of 61 participants in Arlington USA. June 2013
37%
10% 53%
Outstanding
Excellent
Very Good
Good
Attend With Confidence:
Feedback from prior
course attendees
90% of respondents who attended
this course in June 2013 rated it as
‘Outstanding or Excellent’
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5. SAVE TIME!
Quick Registration
Contact Victoria on:
+44 (0)1325 526 000
14.30
14.45
16.00
16.30
08.00
08.30
10.15
10.30
11.30
12.15
13.15
Tea, coffee and refreshments
SESSION VIII: OVERVIEW OF
HUMAN FACTORS MEDICAL
DEVICE STANDARDS
During this session we will start
by answering any questions from
previous days and then will focus
on:
Identifying the current standards that
apply to both the human factors process
and device user interface design
Relating the standards to their specific
regulatory relationships to FDA and
international regulatory bodies’ processes
Morning refreshments and
networking break
SESSION IX: APPLICATION
OF HUMAN FACTORS IN
MEDICAL DEVICE DESIGN
During this session we will cover
an:
Incorporated Human Factors from design
inception
Followed the FDA’s Human Factors
guidances and ISO* IEC** standards
* International Organisation for Standards
** International Electrotechnical Commission
Q&A & VALIDATION
EXERCISE INTRODUCTION
An introduction to the subject
matter and exercise that will be
worked on after lunch.
Networking lunch
SESSION X: VALIDATION
EXERCISE
During this session we will teach
you how to identify
characteristics of a good Test
Plan.
Workshop Activity:
During this session groups will
use the same device selected for
their formative test and transition
to simulated use of validation
methodology. The learning
outcomes from the activity
are centred on identification of
actions and action planning. i.e:
Identifying characteristics of a good HF
plan
Creation of a HF plan (discussion)
Evaluate and make suggestions for
improvements when given a scenario
Afternoon refreshments and
networking break
SESSION XI: VALIDATION
STUDY DISCUSSION
SESSION XII: END OF CLASS
Q&A
END OF CLASS
Want to know more?
Call us to have a chat: +44 (0)1325 526 000
It was very valuable
to get the most recent
updates to materials
and learn what will
be in future editions
of guidances and
standards
Attendee ref : 5029. May 2012 course
Want to send a
group of people to
this class? Groups
of three or more
receive substantial
discounts!
Programme
Day 3
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ALL DELEGATES
RECEIVE
An interactive seminar-workshop
format, including lots of question
and-answer and discussion
opportunities
Detailed ‘real world’ case studies
and illustrations plus examples
from other businesses
Comprehensive seminar materials
including:
Workbooks and presentation
materials
Technical information reports
Pertinent FDA documents
Additional references
Insights into (and copies of)
relevant standards
Examples, templates, guidelines
and checklists
Lunch and networking break
refreshments on all days
A complimentary drinks
reception on the first evening of
the event
6. Robert A. North, PhD. Robert is Chief Scientist for Human Centered Strategies and an expert
on human performance modelling and prediction. Bob is an expert in; use error analysis and
prediction / prevention for home and hospital medical devices. Prior to his consulting career,
he managed the human factors departments at Medtronic and Honeywell International. Dr.
North is a co-author on FDA human factors standard: ANSI/AAMI HE-75 Human Factors
Design Guidelines for Medical Devices and is also a recognised expert on IEC-60601-1-6
Collateral Standard, Electronic Medical Devices – General: Usability and ANSI/AAMI HE-48,
Human Factors Design of Medical Devices. He has served as an adjunct faculty member for
short courses (representing the FDA's position) on Design Controls for manufacturers and
written over a dozen scholarly articles on human factors, that include co-authorship of a paper
published in the International Journal of Industrial Engineering. Dr. North holds a doctorate in
Engineering Psychology from the University of Illinois.
Ed Israelski, PdD. Ed is known worldwide for his work on Human Factors and through the
Ergonomics Society. He is director of human factors at AbbVie, a biopharmaceutical company.
Ed is a past co-chair of the AAMI Human Factors Engineering committee which develops HF
standards for medical devices. He is also the convener of both JWG4 and MT 25 with IEC and
ISO in developing international HF medical standards. He is a certified human factors
professional CHFP. He has authored fourteen book chapters and numerous articles in the area
of human factors. A holder of thirty patents, Ed is a fellow of the Human Factors and
Ergonomics Society and a member of APA, UPA and previously the National Academy of
Sciences Committee On Human-System Design Support For Changing Technology. He has
been a juror for the MDEA medical device excellence awards and is named in the MDDI list of
100 notable people in medical device development (‘08). Prior, he was technical manager of
the human factors systems group at Lucent Technologies - Bell Labs, formerly AT&T. Later he
was director of HF for SBC/Ameritech where his organisation supported the design and
evaluation of user interfaces for telecommunications products. In 2000, he became chief
technology officer at Human Factors International, a user interface design and consulting firm
in information technology. He received a B.S. in electrical engineering from New Jersey
Institute of Technology, an M.S. in operations research from Columbia University and a Ph.D.
in industrial and engineering psychology from Stevens Institute of Technology.
Ron Kaye, MA. Ron is the Human Factors Pre-Market Evaluation Team Leader for the U.S. Food
and Drug Administration (FDA) located in the CDRH Office of Device Evaluation (ODE) and
within the Division of Anesthesia General Hospital and Infection Control Devices (DAGID). Ron
has a BS degree in Psychology and Biology, and a MA in Applied Psychology. He has worked
in Human Factors for 30+ years, 15 of which have been with the FDA’s Centre for Devices and
Radiological Health (CDRH). Prior to joining the FDA, Ron worked with Human Factors and
human performance testing, training analysis, and research on safety-critical systems such as
nuclear power plant control rooms, military weapons and communications systems, aircraft
cockpit systems, air traffic control systems, and medical devices.
Our faculty are drawn from a uniquely experienced group of professionals
from the medical device industry ensuring a balanced presentation of
requirements, an improved understanding of industry practices, paths to
quality compliance and standards for application. It includes:
The Course Faculty
Our World-Class course faculty is
led by seasoned Human Factors
experts Dr. Robert A. North
and Dr. Edmond Israelski
with additional live Q&A Video
Conferences led by Ronald Kaye
from the FDA .
7. Standard Price £2,150
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period of 12 months (from the date of cancellation). Where bookings are made in the 28 days immediately prior to the
class, only credit notes will be offered should delegates wish to cancel or not be able to attend.
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3 Day Course
Book your place online today at
medical-device-regulations.com
1 Save time and clear your device for
market quicker, by learning how to cut down
‘additional information’, ‘clarification’ and
‘iteration’ requests from approval body
reviewers.
2 A unique opportunity within Europe to explore
the FDA’s current thinking about Human
Factors and the process of pre-market
approval / conformity assessment etc.
3 Receive a set of submission criteria that
reviewers look for when reviewing the
‘validation of use’ data you provide (including
how to report all human factors work in
development).
4 Learn to avoid the common critical omissions
that slow down decision-making.
5 Engage with a unique and World Class faculty
that includes the chair of the Usability
Standards Committee and the FDA (the gold
standard for global device assessment).
6 Understand why formative testing is
becoming an important and expected aspect
of pre-market submissions.
7 Gain new guidance on doing preliminary
analyses (i.e. user profile models,
environmental / task analysis and anatomy of
use errors etc).
8 Discuss deficiency, recall and warning letters
in reviews of pre-market submissions.
9 Participate in formal and informal discussions
throughout the course to apply classroom
learning to your real-life situations.
10 Leave with the knowledge and techniques to
implement HF engineering and prepare your
findings for submission.
KEY
REASONS
TO ATTEND10
For more information contact Victoria Slee on:
+44 (0)1325 526 000
