This one-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. 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 IEC 62366 and FDA human factors guidelines. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study
Please note we are also running Nasal Drug Delivery
on the 6-7 April 2017 and should you wish to attend both the Nasal Drug Delivery
conference and the Human Factors
workshop a £200/€200 discount
will be available, please enter code HFNDD
in the promotional code box when booking on-line to receive the discount or call Customer Services on +44 (0)20 7749 4730
Why you should attend
By attending this seminar you will:
- Understand the requirements of IEC 62366 and FDA Human Factors Guidance
- Know how to provide the regulators with specific usability data for your device
- Ensure you test the right product
- Learn how to get the human factors right for combination products
- Ensure you get the right study participants
- Find out how to set up simulated use environments
- Consider the labelling, packaging and the instructions
- Discuss training strategies for your device
Who should attend
This seminar will be beneficial to those working in the following areas:
- Engineering and device development
- Regulatory affairs
- Quality systems
- Quality assurance
- Risk management
- Usability and human factors engineering
- Requirements of IEC 62366 and FDA Human Factors Guidance
- How to provide the regulators with specific usability data for your device
- Starting at the right place – how and when should you start planning your human factors study?
- Test the right product – it sounds simple, but it is very easy to end up testing the wrong prototype, or the wrong design iteration, or even someone else’s product! So how do you decide what to test?
- Combination products – how and why are combination products different and how do you get the HF right for them?
- Who are your users – your intended users may not be who you think they are. So who are they, what do you know about them, and how do you make sure you get the right study participants?
- Simulated use environments – depending on the type of study, you may need to use a higher fidelity test environment, and if so, what are the important environmental factors to incorporate?
- Don’t forget the labelling, packaging and the instructions – they are part of your device user interface, and they must be tested. But what exactly needs to be tested, and how should you do it?
- Training – will your users be trained to use your device? What training materials will you provide? Or is yours a home-use device, in which case do you need a no-training group?
- Frequent versus worst case scenarios – which ones should you include? Do you need to test every possible scenario?
Richard Featherstone is Human Factors Director of Medical Device Usability Limited, a specialist human factors consultancy that works exclusively with new and emerging medical technologies. He has been designing and conducting human factors studies for over 10 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. He and the MDU team regularly test in the US, UK, Europe and Australia and undertake formative and summative testing for some of the world’s largest pharmaceutical and medical device companies as well as small start-ups. Based in Cambridge, MDU has grown rapidly to become Europe’s largest specialist medical HF consultancy with clients around the world. Over 10 years of testing has meant that Richard has built a considerable body of knowledge of the practical aspects of designing, undertaking and reporting of both types of testing.
Previous customers include...
- Ablynx NV
- Alk Abello A/S
- AOP Orphan Pharmaceuticals AG
- APTAR FRANCE SAS
- Bespak Europe Ltd
- Boehringer Ingelheim Pharma GmbH & Co. KG
- CSL Behring
- DCA Design International
- Eveon SA
- Flextronics Design srl
- Indivior Plc
- Knowledge Pool Group Ltd
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Medicines and Healthcare Regulatory Agency
- Orion Corporation Orion Pharma
- Portal Instruments
- Presspart Manufacturing Limited
- Provensis Ltd, a BTG International Group Company
- Research and Markets
- Segulah Consulting Limited
- Vetter Pharma International GmbH