Guest Speaker Archives

Needs Assessment and Product Requirements

• Elements of Design and Development (focus on Product Requirements)
  • Tammy Carrea, Sicel Technologies
    • 11/12/08 Talk on Product Requirements
    • Product Requirement Examples
    • 1/29/09 Talk on Manufacturing Specifications
• User Needs and Product Requirements
  • Ted Mosler, Gilero
    • 9/17/08 talk
    • 9/27/07 talk
    • 10/05/06 talk
• Introduction to Engineering World Health and Need Finding
  • Bob Malkin, Professor of the Practice, Duke Biomedical Engineering
    • 9/15/08 talk
    • 9/11/07 talk

Industry Perspectives on Product Development

• Product Development in the US Medical Regulatory Environment (11/1/07)
  • Claire Laverde, Sr. Design Engineer, Clinical Technologies and Services, Cardinal Health
    • 11/17/08 Talk
    • 11/1/07 Talk
• A Real World Look at Design Controls (2/8/07)
  • Samir Dandekar, Director of Business Development, Code Refinery
• Free Design and The Open-Source Hardware Movement (11/21/06)
  • Chuck Messer, Tackle Design
  • [ Wheelchair PDF] [ Bookmarks]
    
• Product Development Presentation (a real world perspective) (9/21/06)
  • Harold Trammel, Sr. Project/Design Engineer - R&D, BD Biosciences

Legal (Invention, IP, and Tech Transfer)

• Introduction to Intellectual Property (9/10/08)
  • Mindy Fleisher, University Outreach Coordinator, USPTO
• Introduction to the IP Disclosure (2/14/08)
  • Terry Bray, NCSU Office of Technology Transfer
    
• Searching for Patents and Prior Art (9/13/07)
  • John Calvert, United States Patent and Trademark Office
• Intellectual Property (2/22/07)
  • John Tehrien, Smith Anderson
  Searching for Patents and Prior Art (10/3/06)
  • John Calvert, United States Patent and Trademark Office

Quality, Regulatory, and Risk Assessment

• From Larry Pope's Presentation (3/20/08):

  • Process Validation Presentation
  • GHTF Process Validation Guidance
  • Example PDF Conversion Validation
  • Example X-ray Validation Plan
  • MDI Validation Plan and Protocol
  • Project Quality Plan Template
  • Quality Plan Template

• Qualification Validation (3/13/07)
  • Larry Pope, Advanced Liquid Logic
• Biomaterials Review (2/6/07)
  • Lois Smart
• Quality Planning for the Product Design to Manufacturing Transition (11/7/06)
  • Larry Pope, Advanced Liquid Logic
    [PRR-checklist] [ Quality Plan Template] [ Roles & Resp.] [ Technical Eval Checklist]
• Regulatory and Risk Assessment (10/24/06)

  • Rita Geiger, President, InfoStrength

Manufacturing and Prototyping

• Polymer Basics and Plastic Part Design (1/15/08)
  • Dan Fuccella, Applied Technologies [Choosing the Right Plastic] [Part Design Basics]
  • Plastic Selection Considerations based on Dan's 1/27/09 talk (Excel file posted 2/12/09)
• Rapid Prototyping and Medical Modeling (11/16/06)
  • Dr. Ola L. A. Harrysson, NCSU Industrial Engineering

Career Planning

• Career Advice (10/31/06)
  • Andrew DiMeo, Senior Design "Featured" Speaker

Hospital Orientation

• WakeMed Orientation (1/19/08)
  • Carnessa Ottelin and Ylenia Sharif, WakeMed Health and Hospitals

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