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Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

★★★★★ "As a newcomer to this field, I had hoped for a thorough introduction to Usability Testing. I am plea... more (24)"

5-6 December 2024
+ 15-16 January 2025, 13-14 May 2025, 16-17 September 2025 »
from £1099

Need help?  Enrol or reserve

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Course overview

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device to comply with the MDR. The format for the day will be interactive with the presenter sharing his experiences as a specialist with extensive knowledge and understanding of the requirements of the MDR, IEC 62366 and FDA human factors Guidance. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of attending

  • Understand the requirements of IEC 62366 and FDA human factors Guidance
  • Know how to provide the regulators with specific usability data for your device
  • Understand human factors and the design process
  • Learn how to validate combination products
  • Consider human factors and risk
  • Discuss generic combination products – ANDAs and HF
  • Find out what HF data FDA require for biosimilars

Who should attend?

This event will be beneficial to those working in the following areas:

  • Engineering and device development
  • Packaging
  • Regulatory affairs
  • Quality systems
  • Quality assurance
  • Risk management
  • Marketing
  • Usability and human factors engineering

Enrol or reserve

This course will cover:

Introduction

  • Scope of the training
  • Expectations for the training

Background to human factors

  • Human factors, usability and ergonomics defined
  • Trends in drug delivery device technology
  • Use errors – scale, scope and implications
  • Defining the user interface
  • Usability research, clinical research and market research compared

Legal and regulatory requirements

  • US law and design control – implications for HF
  • MDR and usability requirements
  • Article 117 and implications for combination products
  • UK medical device regulations

IEC62366, FDA guidance and expectations

  • IEC62366 usability engineering process
  • FDA human factors guidance
  • ISO14971 applied to combination products
  • EMA guidance on combination products
  • Chinese human factors guidance 2022

Human factors methods and best practices

  • Human factors engineering
  • Perception, cognition and action model
  • Heuristic analysis

Design control, design and development

  • Design and development planning
  • Role of human factors in design control
  • UE methods and outputs
  • UE integration with combination product development

User needs & user interface specifications

  • Regulatory requirements for user needs
  • Defining formal user needs
  • User requirements and the design trace matrix
  • Building a user interface specification

Formative and validation testing methods

  • Formative testing methods
  • Human factors validation methods

Use-related risk

  • Regulatory requirements for use-related risk
  • ISO14971 applied to combination products
  • Risk analysis methods
  • Risk control
  • Residual risk analysis

HF and clinical trials

  • How HF and clinical trials differ
  • How to gather HF data during clinical trials
  • Changing the user interface during the trial program
  • HF requirements for INDs and IDEs

Technical data requirements

  • HF contents of a design history file
  • HF contents of a EU technical file

Predicate devices, platform devices and post-market surveillance

  • Platform devices – how to incorporate HF
  • Platform device due diligence
  • Post-market HF requirements – US and EU

Generic devices, biosimilars and ANDAs

  • How to do a database and literature search for known use problems
  • ANDA submissions and HF
  • ANDA versus 505(b)(2) HF requirements
  • FDA HF requirements for biosimilars 

Practicalities – how to stay legal

  • GDPR, IRB, HIPAA and the Sunshine Act
  • When to apply for ethics/IRB approval
  • Common GDPR problems during HF testing

Wrap-up

  • Common pitfalls and top tips
  • Top tips

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Richard Featherstone
Knowledge Specialist Ltd

Richard Featherstone was one of the early pioneers of applying human factors research methods to combination products, having set up Medical Device Usability in 2008. Richard has been designing and conducting human factors studies for over 15 years, and his experience includes a wide range of drug delivery technologies including inhalers, auto-injectors, nasal sprays and associated devices such as tele-health systems. Following his most recent role as Research Director in Human Factors for Emergo by UL, Richard is now providing freelance consultancy and training services. Richard has advised some of the world’s largest pharmaceutical and medical device companies as well as small start-ups. Over 15 years of human factors work has meant that Richard has built a considerable body of knowledge of the regulatory requirements for usability testing, in particular in a European context.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

5-6 December 2024

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Timings may be different for each day
Course code 13998

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 31 Oct

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Not ready to book yet?

for 7 days, no obligation

15-16 January 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Timings may be different for each day
Course code 14548

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 11 Dec

View basket 

 
Not ready to book yet?

for 7 days, no obligation

13-14 May 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Timings may be different for each day
Course code 15126

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 08 Apr

View basket 

 
Not ready to book yet?

for 7 days, no obligation

16-17 September 2025

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 14723
Optional £270/€351/$405 per night

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 12 Aug

  • 2 days classroom-based training
  • Optional accommodation - 2 nights including breakfast, checking in the day before the course
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Human Factors and Usability Engineering in the Development of Drug Delivery Products training course


As a newcomer to this field, I had hoped for a thorough introduction to Usability Testing. I am pleased to say that my expectations were met. Additionally, I had looked forward to networking, and I found ample opportunity to do so.

Jun 5 2024

Bettina Meervaldt Larsen
Global Trial Manager, Novo Nordisk

Jun 5 2024

The speaker has remarkable experience that he tried to share with us, which was really appreciable. He had also the ability to adjust the agenda to cover our points of interest. He tried to mix between theory and real-life examples. Discussing with him was really informative.

Haymen Girgis
Associate Director Medical Affairs, Becton Dickinson

Jun 5 2024

I was hopping to understand the meaning of Human Factor and Usability in the Generic context and I obtained this knowledge.

Iñigo Gamboa
Medical Advisor, Cinfa S.A.

Nov 27 2023

Richard is very knowledgeable in the topic and was able to answer all questions by providing both regulatory references and examples which made understanding requirements easier.

Geno Govender
Senior Manager - Quality Devices, Vectura Limited

Nov 27 2023

Richard was very keen of answering any questions coming from the participants and trying to adapt the training course to the participants needs/requests.

J.Ignasi Escamilla
Device Development Advisor, Ferrer Internacional S.A.

Mar 7 2023

Overall I really enjoyed the course - good discussions.

enrica papi
HF manager, GSK

Dec 7 2022

Everything was perfected. If i have a another chance to sign up, I definitely will do

Jiyoung Won
Student, Dongguk University

Dec 7 2022

His lecture was so good. Thank you

Jinsoo Lee
Student, Donggukuniversity

Sep 14 2022

A+, one of the best webinars I've attended. I was hoping to learn more about Human Factors development to strengthen our R&D team. The presenter, Richard Featherstone, was excellent at going over every single detail. Was definitely accomplished. Richard was very thorough and informative for an individual who had no prior experience with Human Factors. The simplicity, organization, overall flow, and the amount of information within the webinar.

Brent Nelson
Director, Analytical R&D/QC, Renaissance Lakewood, LLC.

Sep 27 2021

Richard was great. He made sure we were engaged at all times and was very conscientious that we were happy with what we were learning throughout and made it clear he was happy to tailor anything to fit our needs and expectations.

Georgia Rolland
Project Co-ordinator, Cambridge Design Partnership

Sep 27 2021

This training provided a comprehensive view of what is expected from regulators. [Richard] paid attention to speak clearly (appreciated from not-native English speakers) and was attentive to the participants.

Emmanuelle Tourte
Head of Regulatory Compliance & Data Management, Guerbet

Feb 23 2021

A great webinar on human factors. Great presenter with a lot of knowledge on the subject!

Pontus Adler
Research Scientist, Camurus AB

Feb 23 2021

Richard was very knowledgeable, engaging and approachable. He was clearly passionate about his subject, which was infectious. I was very happy with this course and would gladly recommend it to others.

Charlie Irving
Senior Design Engineer, Renishaw Neuro Solutions Ltd

Sep 30 2020

I like the fact that (the speaker) took the time to answer questions

Jos Wesselman
Sr. Manager Development, Basic Pharma Technologies B.V.

Sep 30 2020

Despite being on-line it has been very interactive. The presenter is an expert on the matter and explains in a very clear and concise way.

Alba Marcé
Regulatory Affairs Specialist, Grifols, S.A.

Sep 30 2020

The content, presentation and speaker have been very good. The online version of the course has also work well. The only "problem" with the online version of the course is that we do not have direct interaction with other participants. So, at some point it would help to connect everybody with camera to share opinion or experiences.

Laura Lopez Vicente
R&D Manager, Instituto Grifols S.A.

Oct 2 2019

I am very satisfied with the course. I learnt a lot and the subject of HFE studies is much clearer to me. We were able to have very good discussions with the speaker who seemed to be very knowledgeable.

Nina Bladh
Director CMC Regulatory Affairs, Camurus AB

Feb 27 2018

Really great overview, could be more detailed but would require more time. Richard gets an A+

Matthew Gottschalk
Director of Human Factors - Europe, Worrell

Apr 5 2017

Very informative, clearly giving in depth and suitable info

Emily Clements
Market Research, Nemaura Pharma Ltd

Apr 5 2017

Speaker was very responsive to specific questions, which I appreciated

Andrea Fernandes
Manager, Integrated Care Strategy, Portal Instruments

Apr 5 2017

All good - content and instruction

Herve Pacaud
Business Development Director, Aptar France SAS

Jun 15 2016

The course content is very relevant for anyone who is a beginner (like myself) in HF studies, the presentation style was informal and relaxed which helped the attendees to take part and there was plenty of useful audience participation

Valerie Joynson
Senior Scientific Assessor, MHRA

Jun 15 2016

Very good, well presented and met my expectations - adapted to non-expert

Claire Jahan
Market Intelligence, APTAR FRANCE SAS

Jun 15 2016

Very good, pace right and a good refresher

Joe Neale
Director, Technical Development, Provensis Ltd, a BTG International Group Company

United Kingdom

  • 3M
  • Bespak
  • Bespak Europe Ltd
  • Biocompatibles UK Ltd.
  • Boston Scientific
  • Cambridge Design Partnership
  • Chiesi
  • DCA Design International
  • GlaxoSmithKline
  • GSK
  • Independent
  • Indivior Plc
  • Maddison ltd
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicines and Healthcare Regulatory Agency
  • MHRA
  • Nemaura Pharma Ltd
  • Nicovations
  • OrganOx Ltd
  • Owen Mumford Ltd
  • Pfizer R&D UK
  • Presspart Manufacturing Limited
  • Provensis Ltd, a BTG International Group Company
  • Renishaw Neuro Solutions Ltd
  • Springboard Pro Ltd
  • Vectura Limited
  • Worrell

France

  • AdhexPharma
  • APTAR FRANCE SAS
  • Becton Dickinson
  • Eveon SA
  • Guerbet

Germany

  • Boehringer Ingelheim Corporate Center GmbH
  • Boehringer Ingelheim GmbH & Co KG
  • Boehringer Ingelheim Pharma GmbH & Co. KG
  • medac GmbH
  • Vetter Pharma International GmbH

Spain

  • Cinfa S.A.
  • Ferrer Internacional S. A.
  • Ferrer Internacional S.A.
  • Grifols, S.A.
  • Instituto Grifols S.A.

United States of America

  • Portal Instruments
  • RAI SERVICES COMPANY
  • Renaissance Lakewood, LLC.
  • Savara Pharmaceuticals
  • Silgan Dispensing Systems

Denmark

  • Alk Abello A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • Zealand Pharma A/S

Italy

  • Chiesi Farmaceutici
  • Chiesi Farmaceutici SpA
  • CHIESI SPA

Korea, Republic Of

  • AJOU University
  • Dongguk University
  • Donggukuniversity

Netherlands

  • Basic Pharma Technologies B.V.
  • Venn Life Sciences ED B.V.

Switzerland

  • CSL Behring
  • ​ F. Hoffmann-La Roche Ltd

Belgium

  • Ablynx NV

Finland

  • Orion Corporation Orion Pharma

Ireland

  • Emergent BioSolutions

Israel

  • Flextronics Design srl

Lithuania

  • AOP Orphan Pharmaceuticals GmbH

Poland

  • HTL-STREFA S.A.

Sweden

  • Camurus AB

Enrol or reserve

Run Human Factors and Usability Engineering in the Development of Drug Delivery Products Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online
Contact us 

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy