aami human factors october
TRANSCRIPT
medical-device-regulations.comRegister online today at:
6th - 8th
October 2015Castleknock HotelDublinIreland
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 facultyLed 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
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.
ProgrammeDay 1
09.00
09.30
09.45
11.00
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NOTE: Day 1 schedule allows delegates to arrive on an early morning flight
Registration
Open and welcome
SESSION I: INTRODUCTION & OVERVIEWDuring 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 PERSPECTIVEDuring 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 APPROVALDuring 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 IDuring 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 COURSEImprove 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_TrainingEUCopy the link above into twitter search bar to hear our latest news and join the discussion...
SAVE TIME!Quick RegistrationContact Victoria on:
+44 (0)1325 526 000
08.00
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Tea, coffee and refreshments
SESSION IV: FORMATIVE EVALUATION AND DESIGN MODIFICATION PART IIDuring 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 TESTINGDuring 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 jobAttendee ref : 10517 . June 2013 course
Great to hear examples of how the FDA evaluates HFE submissions from the people who actually evaluate those submissionsAttendee ref : 10482 . June 2013 course
Image : Toshiba Medical Systems Europe
ProgrammeDay 2
Based on AAMI feedback from an audience of 61 participants in Arlington USA. June 2013
37%
10% 53%
Outstanding
Excellent
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Attend With Confidence:
Feedback from prior course attendees90% of respondents who attended this course in June 2013 rated it as ‘Outstanding or Excellent’
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SAVE TIME!Quick RegistrationContact 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
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Tea, coffee and refreshments
SESSION VIII: OVERVIEW OF HUMAN FACTORS MEDICAL DEVICE STANDARDSDuring 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 DESIGNDuring 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 INTRODUCTIONAn introduction to the subject matter and exercise that will be worked on after lunch.
Networking lunch
SESSION X: VALIDATION EXERCISEDuring 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 standardsAttendee ref : 5029. May 2012 course
Want to send a group of people to this class? Groups of three or more receive substantial discounts!
ProgrammeDay 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
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 .
Standard Price £2,150
TERMS & CONDITIONS
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Registration Form & Price3 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.
KEYREASONSTO ATTEND 10
For more information contact Victoria Slee on:+44 (0)1325 526 000
Sample attendeesOver 100 organisations have attended the last two courses in Europe. Here is just a sample of them...
Calon Cardio Technology, Covidien, St. Jude Medical, Matchstick LLC, Stratos Product Development, Boston Scientific, Novo Nordisk, Abbvie, Bayer Corp, DexCom Inc, Medimmune LLC, Fresenius Medical Care, Deka Research and Development Corp, DePuy Synthes, Thoratec Corp, NNE Pharmaplan, GFK Custom Research, Abbott, Stryker, Instrumentation Laboratory, Kimberly-Clark Corp, Debiotech SA, User Centric Inc, Ethicon Inc, Vnus Medical Technologies, Business Process and Technology Management LLC
www.cambridge-design.co.uk
Cambridge Design Partnership is a successful research, design and development consultancy focused on creating value by converting new ideas and technology into commercial success. Our clients have one thing in common: they see investment in innovation as fundamental to growth and competitive advantage.
Consideration of human factors is a fundamental part of developing safe and effective medical devices and we believe the ‘AAMI Human Factors for Medical Devices’ course is the most comprehensive and authoritative available for those developing new products for US and global markets.
For this reason we have collaborated with Pure Insight and AAMI to make the course available within Europe in order to promote a better understanding of Human Factors in medical devices.
PLEASE NOTE: Accommodation is not included in the Masterclass fee.
The venue has set aside a number of rooms for our delegates at a special rate of €89 B&B per night for a single occupancy room. Mention you are attending this event when booking. NOTE: Any un-sold rooms will be released to general sale 8 weeks before the course starts
The VenueCastleknock Hotel, DublinAward winning Castleknock Hotel is located just 15 minutes from Dublin City centre, 20 minutes from Dublin Airport with easy access from the M50 motorway. The hotel includes a luxurious leisure centre with an 18 metre swimming pool boasting panoramic views of the local countryside, lake and 18 hole golf course next door. Free parking is also available on site.
T: +353 1 640 6300 | W: www.castleknockhotel.com
Porterstown Road, Castleknock, Dublin 15, Ireland
EVENT HOST
EVENT SPONSOR
WHO SHOULD ATTEND?
Don’t wait for a ‘warning letter’ toreconsider your company’s approachto user related risk...
This is a course for ANYONE involved in device (or combination device) development. As the only course of its kind in Europe, the class provides an opportunity to participate, share and learn from regulatory representatives and industry peers from around the globe. Previous participants include:
Quality and design engineers, research and development managers, project managers, combination device manufacturers, risk managers, personnel from marketing, human factors, regulatory affairs etc, as well as process owners, software engineers, quality assurance managers. As well as clinical/medical affairs, CAPA or supplier/purchasing representatives, customer service staff, compliance officers and government regulators who are new to the application of human factors to medical devices.
© Pure Insight 2015. All rights reserved. Other than for use in relation to its original purpose, no part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, mechanical, photocopying, recording or otherwise, without the prior permission in writing of the publishers.
Supporting all Pure Insight Innovation Masterclasses in 2015
Pure Insight is based in the UK and works with global organisations to help them build sustainable innovation management programmes, based on industry best practice.
To find out more about what we do, contact
Anna Charles:
+44 (0)1325 526 000