Speaker: Jose Ignacio Mora
Speaker Designation: Principal Consultant, Atzari Consulting, LLC
Human Factors/Usability is the analysis of how people interact with medical devices. Human factors usability validation is a process of evaluating a product's usability by testing it with representative users in a simulated or real-world environment. The objective of human factors usability validation is to identify and address potential usability issues and ensure that the product is safe, effective, and easy to use.
The process involves planning and preparation, selecting appropriate participants and testing environment, conducting user testing and data collection, analysis and interpretation of data, and reporting and documentation of results. A successful human factors usability validation can improve the product's usability, user satisfaction, and overall market acceptance.
This webinar will guide attendees through the process of conducting human factors studies from start to finish. The speaker, Jose Mora, will explain how to integrate these studies with device risk analysis and will cover the process of validating the effectiveness of the studies.
Following the implementation of the results of a Human Factors/Usability study, he will explain how it is necessary to conduct a validation to ensure the device's safety and effectiveness during use. He will be explaining why a number of validation participants from each "distinct user population" are required by the FDA. He will also explain how to choose the tests to be conducted and the studies that need to be completed prior to the actual validation test. Furthermore, Jose will be describing how to perform the critical post-test participant inquiry, which is important for the success of the validation.
Handouts are: usability validation tracking form, protocol form, and test results report form.
Human Factors Usability Validation (HFUV) is a critical process in the development and deployment of products, systems, or interfaces, especially in industries where user interaction plays a pivotal role, such as healthcare, aviation, and consumer electronics. 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.
José 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, now a Cardinal Health company, 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 José’’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.
