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.
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
Agenda
Day 1
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
Day 2
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
Speakers
Mr Richard Featherstone,
Human Factors Director ,
Medical Device Usability LimitedRichard 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.
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
