Human Factors and Usability Engineering in the Development of Drug Delivery Products

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

27 Feb 2018

GBP 699
EUR 979
USD 1,090

Book now

Introduction

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

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
  • Packaging
  • Regulatory affairs
  • Quality systems
  • Quality assurance
  • Risk management
  • Marketing
  • Usability and human factors engineering

Programme

Welcome and introductions

Guidance, standards and the law – what MUST be done

  • Requirements of IEC 62366 and FDA Human Factors guidance
  • What is the legal and regulatory status of human factors
  • How do the European and US requirements compare?
  • Which guidelines should I be following for my product?

How to provide the regulators with specific usability data for your device

  • What are the regulators looking for?
  • What are their requirements?
  • Successful applications – how to maximise the chance of a successful review

Starting at the right place

  • How and when should you start planning your human factors study?

Combination products

  • How and why are combination products different
  • How to get the Human Factors right for them
  • ANDAs – what human factors data do I need if I am submitting an ANDA?

How to pass the validation study

  • Do I need to do a validation study?
  • How do I know if my product will pass the validation?
  • How to avoid the common pitfalls in validation studies
  • US versus Europe – do I need to run a validation study in both locations?

Setting up a HF study – who are your users?

  • Key points to consider when setting up a HF study
  • Your intended users may not be who you think they are
  • How to establish the users of your product
  • How do you make sure you get the right study participants?

Testing the right product

  • How do you decide what to test?
  • Ensuring you avoid testing the wrong prototype or the wrong design iteration

Simulated use environments

  • Using higher fidelity test environments
  • Important environmental factors to consider

Labelling, packaging and the instructions for use

  • Packaging, labelling and instructions are part of the device user interface
  • Testing the packaging and labelling
  • What needs to be tested?
  • How to test successfully

Training considerations

  • Will your users be trained to use your device?
  • What training materials will you provide?
  • Is the device a home-use device, in which case do you need a no-training group?

Frequent versus worst case scenarios

  • Which scenarios should you include?
  • Do you need to test every possible scenario?

Presenter

Richard Featherstone

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.

Book now

27 Feb 2018
27 Feb 2018 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

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
  • Independent
  • Indivior Plc
  • Knowledge Pool Group Ltd
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicines and Healthcare Regulatory Agency
  • MHRA
  • Nicovations
  • 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
  • WestRock