Human Factors and Usability Engineering in the Development of Drug Delivery Products (Online: May 13-14th)

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.

Click here to attend: https://bit.ly/426hLUz

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