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CMMI Institute

Capability Counts 2018

Speaker Profile

Robert Becker, Director of Quality

Edwards Lifesciences

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About

Rob Becker is currently the Director of Quality for Edwards Lifesciences Draper, Utah facility. Rob joined Edwards Lifesciences in 2010 to support initial device manufacturing for transcathether aortic valve replacement (TAVR) and has supported subsequent capacity and organizational growth. He has 25 years of experience in manufacturing and operations, including appliances, disk drives, and medical devices, preferring the dynamics of transitioning emerging technology to commercial stability. Rob holds a BS in Electrical Engineering from Cornell University and an MBA from the University of Utah.

SPEAKER PRESENTATION

Medical Device Discovery Appraisal (MDDA) Pilot Experience

Conference Track: CMMI in the Healthcare Industry

Medical Device companies commercializing innovative technology experience challenges balancing the need for continuous improvement and the constraints of the regulatory environment. Traditional focus on a compliance first approach does not address many of the critical elements that affect product quality and promote safe and effective medical devices. The MDDA Pilot provides companies the opportunity to participate in an alternate approach to compliance using the CMMI as the baseline for assessment. Edwards Lifesciences experience found the CMMI was less expensive and disruptive to business activities, provided actionable feedback for improvement, and integrated well with other feedback and planning inputs.