Agile Methods in Medical Device Development
Agile methods are well established in software development, and have been recognized by FDA as a valid alternative to the waterfall development approach typically applied in medical device Design Control systems.
By drawing on personal experiences using agile methods in medical device development, the speaker will explore:
• How agile methods can work for systems (hardware as well as for software)
• How to leverage an agile approach most effectively in a regulated environment
• How to incorporate external partners – including product development teams – in an agile development framework.
Chris Danek, PhD, MBA – Interim Executive and Advisor
Chris helps commercial and pre-commercial life sciences companies achieve operational excellence. Chris co-founded AtheroMed (acquired by Volcano) and was its CEO and later CTO. Earlier, he served as VP, R&D at Asthmatx (acquired by Boston Scientific). He has extensive experience leading cross-functional teams in the development of innovative solutions to difficult clinical problems, and as a senior manager of R&D, Operations, and Quality. Chris received a PhD in mechanical engineering from Stanford University, an MBA from The Wharton School, University of Pennsylvania, a Bachelor of Mechanical Engineering from The Catholic University of America, and is an inventor on over 50 US patents.
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