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
25-26 Sep 2019
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:
Welcome and introductions
Guidance, standards and the law – what MUST be done
How to provide the regulators with specific usability data for your device
Starting at the right place
How to pass the validation study
Setting up a HF study – who are your users?
Testing the right product
Simulated use environments
Labelling, packaging and the instructions for use
Frequent versus worst case scenarios
Richard Featherstone, 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.