User Needs - Creation to Design Validation

Elizabeth Bononno
Mar 18, 2021 - 01:00 PM
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A key aspect of developing a medical device that users find safe, efficient, effective, delightful (and a host of other adjectives) is understanding what users need. This webinar discusses approaches to creating and validating user needs and the role of Human Factors Engineering throughout the design and development process.

Why Should You Attend:

The development of a medical device may begin with an idea, but does that idea serve what users need? This webinar will discuss the role of Human Factors engineering in the research, definition, evaluation and testing of user needs throughout the development process and in collaboration with a cross functional team.

This webinar provides individuals with an opportunity to learn about how user needs are researched, defined, evaluated, and validated during the product development process. Human Factors engineering plays a valuable role in support of this effort during each phase of development. Learn about how deliverables required by Human Factors standards can be leveraged to support user needs from device inception to commercialization.

Design Validation means establishing by objective evidence that device specifications (outputs) conform with user needs and intended use(s) on a consistent basis. Ensuring user needs are correctly understood and defined for users and their environment(s) when a medical device is designed and developed is essential. Correctly defining user needs and assessing the design’s effectiveness, efficiency, and safety throughout development with the help of Human Factors expertise can streamline the Design Validation process. Has your organization established and maintained 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 user and patient? Are you able to validate the design in a simulated use or actual use environment that provides objective evidence that the medical device is safe, effective and meets your user’s needs? Do you understand what is considered necessary for design validation including the medical device’s packaging, labeling and instructions for use?

Areas Covered in the Webinar:

  • What is a user need?
  • How are user needs defined?
  • The role of Human Factors Engineering
  • Evaluating user needs
  • What is Design Validation?
  • Requirements for Design Validation
  • Role of the Project Team
  • Validating user needs

Who Will Benefit:

  • Human Factors Engineer
  • Usability Engineer
  • Project Manager
  • Product Manager
  • Marketing
  • Requirements Engineer
  • Software Engineer
  • Mechanical Engineer
  • Systems Engineer
  • Quality Engineer
  • Risk Management
  • R&D Leadership
  • Customer Service
  • Field Service
Webinar Events
Attend Live Webinar
Mar 18, 2021 - 01:00 PM

Duration: 90 Minutes

Single Attendee

Group-Max. 10 Attendees/Location (For Multiple Locations Contact Customer Care) Super Deal - Get CD/USB Drive Free!


Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Elizabeth Bononno, Owner and Founder, EB-UX Consulting, LLC

Elizabeth Bononno is an accomplished business owner, AAMI Human Factors Board Member and Certified Usability Analyst who brings a diverse skill set to strengthen and improve the client and user's experience. Her experience spans over 25 years of practical Marketing, Product Management, User Experience and Design Validation knowledge with medical devices and business to consumer website content research, development and analysis. Her mission is to ensure the customer and device interface quality come first through the education of teams, effective interpretation of industry standards and creation of functional practices that establish a customer focused culture and a trusted, empowered organization.

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