How Human Factors Helps Mitigate Risk, Encourage Adherence and Promote Brand Loyalty-Ed Geiselhart -10/18/2011 - 8:30am

Event Information
Event Topic: 
How Human Factors Helps Mitigate Risk, Encourage Adherence and Promote Brand Loyalty
Event Date: 
10/18/2011 - 8:30am
Event Location: 
Sunnyvale City Council Chanbers, 456 West Olive Ave., Sunnyale, CA
Speaker Information
Event Speaker: 
Ed Geiselhart
Event Speaker Title: 
Director, Product Development and Planning
Event Speaker Company: 
Insight Product Development, LLC
Event Speaker Bio: 

Ed Geiselhart has 18 years of experience working in product development consultancies. Throughout his career, he has leveraged his design background to inform research methodologies and transition research findings into actionable plans to direct strong, needs-based design and development. He maintains heavy involvement in product planning and conducting field research as well as sustaining a presence in the design and engineering development stages of programs to ensure user-based design intent throughout.

Ed’s 10+ years of experience at Insight has included project management of dozens of medical programs ranging in scope from focused, tactical research and design efforts to full turnkey development programs. Ed has spent significant time documenting best practices models to inform Insight’s product development methodology and is tasked with effectively coordinating the efforts of different disciplines for programs of all sizes. He has contributed to several professional articles and been a featured speaker on design and research integration at numerous conferences, both nationally and internationally.

Ed graduated magna cum laude with a Bachelor of Science in industrial design from the University of Cincinnati.

Event Details
Event Details: 

There are various reasons you should be concerned with Human Factors and medical device design. This includes reducing risk, fostering compliance, and pleasing your customers and the market. Another reason is the FDA’s clear statement that “each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the users and patient.” (FDA QSR: Section 820:30). Awareness is just the first step. Ensuring that your process for including Human Factors input throughout your process is key for saving time and money, staying competitive, avoiding lawsuits and getting FDA approval.

This talk will highlight important information that every medical device design organization should know for involving Human Factors in the necessary ways and how including rigorous Human Factors in an appropriate way is actually the short cut to doing ‘discount’ Human Factors. This talk will discuss the standards (such as AAMI's HE75) that are available, what they say, and how to best use them. A variety of important topics related to using Human Factors appropriately for risk mitigation, involving emotion in design, informing your design and development process, and avoiding FDA approval pitfalls will be covered in this presentation.

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