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Podcast: Voices In Validation
Episode:

8 Essentials of Designing for Manufacturability
Category: Science & Medicine
Duration: 00:42:43
Publish Date: 2020-02-25 05:00:00
Description:

Stacey Bruzzese welcomes Roberta Goode back to the show. Today, Stacey and Roberta will be covering the essentials of designing for manufacturability.

 

  • Roberta details the 8 essentials of DFM
  • Why is Designing for Manufacturability important for medical device manufacturers?
  • Does standardization of materials help shorten the product development cycle?
  • What’s the next step after determining the practical part count?
  • What is Poka-Yoke?
  • What other points should be considered when scaling up manufacturing?

 

DFMA References

Assembly Automation and Product Design

G. Boothroyd, Marcell Dekker, Inc. 1992

Product Design for Manufacture and Assembly

G. Boothroyd and P. Dewhurst, G. Boothroyd Dewhurst, Inc. 1989

Marcell Dekker, Inc.  1994

Design and Analysis of Manufacturing Systems

Prof. Rajan Suri University of Wisconsin  1995

Product Design for Assembly: The Methodology Applied

G. Lewis and H. Connelly

Simultaneous Engineering Study of Phase II Injector Assembly Line

Giddings & Lewis  1997

Design for Manufacturing Society of Manufacturing Engineers,

(VIDEO)

Introduction to Design for (Cost Effective) Assembly and Manufacturing David

Steinstra, Rose-Hulman, 2015

IVT’s Medical Device Handbook: http://www.ivtnetwork.com/article/medical-device-validation-handbook

Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.   

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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