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
Newly updated programme
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. 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 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
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
- 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
Programme day one
Legal and regulatory basis for human factors
- US and EU law - the place of human factors
- International usability engineering (UE) standards
- Human Factors Guidance - FDA and MHRA
- FDA and human factors
Human factors and the design process
- Design inputs - how HF can guide your combination product design
- Design verification - examples of formative work for combination products
- Design review - how to use the outputs from formative work to feed into the design review
- Design validation - how human factors fits in the design validation work
- A detailed look at validating combination products
- Objectives, methods, analysis, and reporting
- Common problems with validation
- and how to avoid them
- Latest FDA views on validation data for combination products
Human factors and risk
- Use-related risk analysis (URRA)
- what it is, and how it differs from FMEAs
- Constructing a URRA – a practical exercise for a combination product
- Risk control measures – how to use them, document them and provide evidence that they are effective
- Residual risk – how to do a residual risk analysis
Programme day two
Human factors and the clinical trials programme
- How and where HF activities work in relation to clinical trials
- Differences between HF and clinical studies
- How to gather usability data from your clinical programme
Usability engineering process
- A practical, hands-on UE workshop, using a real combination product as an example
Generic combination products - ANDAs and HF
- Human factors requirements for ANDA submissions
- Critical design attributes
- The role of HF in determining substitutability
- Threshold analyses - latest FDA requirements
- Comparative HF studies - what they are and how to run them
Ethics and IRB
- When is IRB/ethics approval necessary for HF studies?
- Human subject protection during HF studies - risks and mitigations
- Sampling plans - who should you recruit if you don’t know what the drug will be?
- What HF data should you develop for your platform device?
Sharps prevention - simulated clinical use testing
- How to satisfy the FDA guidance on simulated use of sharps prevention features
- What HF data does the FDA want for biosimilars?
- How do FDA review the human factors data for biosimilars?
Mr Richard Featherstone,
Human Factors Director ,
Medical Device Usability Limited
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.
- Engineering and device development
- Regulatory affairs
- Quality systems
- Quality assurance
- Risk management
- Usability and human factors engineering
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.