Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Getting a Device to Market When Class Designation is Evolving

Virginia Lang (Chief Scientist, Hirlan, Inc. & Hirlan Institute of Human Factors)

Vesna Janic (Director of QA/RA, Starfish Medical)

James Jackson (Industrial Designer, Starfish Medical)

Location: 210B

Date: Wednesday, February 6

Time: 1:15pm - 2:00pm

Track: MD&M West: Product Development & User-Centered Design

Vault Recording: TBD

Incorporating device design and human factors into regulatory strategy has proven to be effective in gaining the right type of regulatory approval, especially if your product is moving from Class I through to Class III designation. During the early product development stages, a regulatory strategy needs to begin formulation when a device "go/no go" decision is being made. In this session, you’ll learn how to work with your regulatory and quality team members to plan a phased regulatory strategy that is based in device design and human factors engineering from the earliest point in the research through the development of design controls.

Topics to be covered include:
  • Understanding the principals behind the regulatory requirements for human factors usability and usability testing
  • Exploring how design and human factors can influence regulatory strategy
  • Industry examples demonstrating how using design and human factors appropriately can create a positive regulatory strategy