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World's Largest Event for Medical Manufacturing  MD&M East Jacob K. June 3-5 2008 Javits Convention Center New York, NY
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Conference

Thursday, June 5, 2008
9:00 A.M. - 1 P.M.

Session 403 - Medical Device Design Transfer as a Process

Instructors: David Vogel, PhD., Founder and President, Intertech Engineering Associates, Inc.; Robert Barrett, Lead Systems Engineer, Intertech Engineering Associates, Inc.; Paul DeCosta, Director, R&D, Ethicon Products, J&J Ethicon

Defining the Problem

Production Specifications: How much is too much – how little is too little?

  • Borrowing Techniques from Software Design and Validation
  • Define these terms, describe how concepts can apply to design transfer
  • Planning, Lifecycles, Identifying Requirements,
  • Designing, Implementing, Testing & Validation,
  • Risk Management, and Configuration Management

Developing a Design Transfer Process

  • Example of a Design Transfer Process
  • How to plan it
  • How to document it
  • How to know if it is working
  • What to do if it isn’t

Special Considerations for Outsourced Production

  • Why is outsourced production different
  • How to mitigate risks identified with outsourcing

Dealing with Legacy and Acquired Products

  • Defining the problem
  • How does lifecycle apply to these devices
  • Developing Design Transfer Processes for these “not so special” situations

Note: this session ends at 1:00 pm.

ABOUT THE INSTRUCTORS

David Vogel, PhD., Founder and President, Intertech Engineering Associates, Inc.

David Vogel, Ph.D. is the founder and president of Intertech Engineering Associates Inc., of Norwood, Massachusetts. Founded in 1982, Intertech has served the medical device industry by providing electronics hardware and software development services. Dr. Vogel and his Intertech engineering team have developed engineering processes that facilitate product design compliance with FDA Quality System Regulations (QSR). The product verification and validation services provided by Intertech have had a 100% safety record. Dr. Vogel received a BS in electrical engineering from M.I.T. He earned a master's degree in bioengineering, a master's degree in electrical and computer engineering, and a doctorate in biomedical engineering from the University of Michigan.

 

Robert Barrett, Lead Systems Engineer, Intertech Engineering Associates, Inc.

Robert E. Barrett is a Lead Systems Engineer with Intertech Engineering Associates, Inc., (www.inea.com) in Northern Illinois , with a 20 year progressive track record of leadership, teamwork and results focus, in the areas of software embedded medical device design, systems engineering, quality management and project management. Robert has also spent 18 years with Baxter Healthcare Inc. gaining management experience in a matrix based organization supporting multiple project and process initiatives. Intertech is an outsource engineering service provider to the medical device industry providing services related to product development and validation, validation of quality and production software, training, and management consulting.

 

Paul DeCosta, Director, R&D, Ethicon Products, J&J Ethicon

Paul DeCosta is Director of R&D for Ethicon, a Johnson and Johnson Company. He has over 15 years of experience in medical device new product development and introduction in various leadership roles in R&D and Operations. Prior to joining Ethicon, Paul worked for Hewlett Packard Patient Monitoring Division and Polaroid Corporation Medical Imaging Division.

Paul holds an MBA and an MS degree in Engineering from Massachusetts Institute of Technology, an MS degree in Biomedical Engineering from Rutgers University and a BS degree in Electrical Engineering from Worchester Polytechnic Institute. Paul is a Certified Six Sigma Design Excellence Black Belt and Six Sigma Green Belt.

 

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