Presented by
Management Forum
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)"
16-17 September 2025 »
from £1499
- Format: Classroom
- CPD: 12 hours for your records
- Certificate of completion
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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 part of our range of Medical Devices training courses
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
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
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.
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
16-17 September 2025
Classroom
Rembrandt Hotel
London
09:00-17:00 UK (London)
Course code 14723
Optional £255/€356/$407 per night
- GBP 1,499 1,699
- EUR 2,099 2,379
- USD 2,407 2,719
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
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
- Osler Diagnostics
- 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
Denmark
- Alk Abello A/S
- Genomics Plc
- Novo Nordisk
- Novo Nordisk A/S
- Zealand Pharma
- Zealand Pharma A/S
Germany
- Boehringer Ingelheim Corporate Center GmbH
- Boehringer Ingelheim GmbH & Co KG
- Boehringer Ingelheim Pharma GmbH & Co. KG
- medac GmbH
- PARI Pharma GmbH
- Vetter Pharma International GmbH
France
- AdhexPharma
- APTAR FRANCE SAS
- Becton Dickinson
- Eveon SA
- Guerbet
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
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
Run Human Factors and Usability Engineering in the Development of Drug Delivery Products Classroom for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
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:
