This unique course is aimed at people who have experience with Human Factors application in Medical Devices, have been on an introductory course in past and wish to develop their skills to improve their chances of a right-first-time submission to the FDA.
The course offers you the chance to hear directly from the designer of the initial and on-going Human Factors review process at the FDA, and one of the world’s leading consultants in HF in Medical Devices.
With the experience of over 1000 new device reviews at the FDA and 1000’s of industry applications under their belts, you will learn what the assessor is looking for and how to construct your approach and submission strategy to ensure success.
Ten Reasons to Attend
- Intensive and comprehensive discussion of FDA pre-market perspective, precedents & priorities for every topic presented in the course.
- How the FDA Guidance, “Applying Human Factors etc” applies to your submission to the FDA.
- How to interpret, understand, and respond to FDA feedback on pre-submissions including “Type C” meetings, and pre-submission review deficiencies.
- HF Testing, test theory and test data, test processes, protocol development and sources of test bias.
- Analysis of use-related risks, considerations of IEC-14971, implied or missing methods/priorities.
- “How-to” identify critical user tasks and develop a Use-related Risk Analysis (URRA) from scratch that will be acceptable upon review and prevent unpleasant surprises when your HF submission is reviewed.
- Special considerations discussion, and review expectations of CDER draft guidance for industry – “Human Factors Studies & Related Clinical Study … etc” AND “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA”
- In-class Formative testing, theory and practice using a sample medical device with IFU.
- Group projects beginning with overall HF evaluation plan, identification of users, user groups, use environments, user tasks, task criticality, URRA, formative testing, simulated-use based HF/U (Summative) validation testing, data collection, analysis and evaluation of test data, and HF test report.
- How to avoid vagueness and incompleteness in your submission.
Ron Kaye recently retired from the FDA’s Center for Devices and Radiological Health where he led the development of its Human Factors initiative during his 19 year tenure at the agency. Ron was the lead author of the original FDA human factors guidance released in 2000, and the current HF guidance released in February 2016, which represents the perspective of the FDA on pre-market submission human factors requirements.
During his time at CDRH, Ron participated in over 1000 new device reviews involving human factors work submitted to almost all CDRH divisions, has trained FDA inspectors in HF, and has participated in Agency post-market responses and recalls associated with use error issues. Ron has been integrally involved in the education of the FDA and device manufacturers regarding the human factors process in device design and testing.
Ron’s participation as a faculty member of the AAMI HFE short course has brought the FDA human factors message to over 1200 industry practitioners over the past seven years, resulting in a significant improvement in human factors work for new device submissions.
He has also been a co-author of the AAMI/ANSI (HE-75) Standard, Human Factors in the Design of Medical Devices and has been a member of the international working group that produced IEC 62366, Application of Usability Engineering to Medical Devices.
Dr Robert North
Bob North is Chief Scientist for Human Centered Strategies and an expert on human performance modelling and prediction. Bob is an expert in use error analysis and prediction/ prevention for home and hospital medical devices. Prior to his consulting career, Bob managed the human factors departments at Medtronic and Honeywell International.
Not only is Bob co-author on FDA human factors standard: ANSI/AAMI HE-75 Human Factors Design Guidelines for Medical Devices, but he’s also a recognised expert on IEC-60601-1-6 Collateral Standard, Electronic Medical Devices and FDA/CDRH guidance Applying Human Factors and Usability Engineering to Medical Devices.
He has served as an adjunct faculty member for short courses (representing the FDA’s position) on Design Controls for manufacturers and written over a dozen scholarly articles on Human Factors.