Course Level: Intermediate
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting human factors studies throughout the process, integrating it with the device risk analysis and validating the effectiveness of the studies will be explained.
Following the implementation of the results of a Human Factors/Usability study, a validation of the safety and effectiveness of the use of the device must be conducted.
Areas Covered in this Session
- Usability Engineering
- Risk Management and Usability Engineering
- Use Specification
- Intended Users
- Anticipated User Tasks
- Intended Use Environment
- Human Factors Validation Testing
Why should you attend this webinar?
We will explain why the FDA required a number of
validation participants from each "distinct user population". We will
explain how to choose the tests to be conducted and the studies that must be
completed prior to the actual validation test. The post-test participant
inquiry is critical to validation success. we will describe how to do this.
Handouts are usability validation tracking form, protocol form, and test results report form.
Who will benefit?
Engineers, Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Design Assurance
- Document Control
- Manufacturing Engineers
- Quality Assurance
José Ignacio Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the
Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place.
By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support.
Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.