Originally Aired - Wednesday, November 20 • 9:00 AM - 9:45 AM Pacific Time (US & Canada); Tijuana
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Location: Great America Ballroom K
Title: Product Development 101
Description:
Many entrepreneurial medical professionals have great ideas for a new product, but what does the path to market look like? We have all heard of Design Controls, Verification & Validation, and Regulatory Approval, but what does this all mean? This session will focus on the classic path through a stage / gate process from concept through V&V to regulatory approval and finally design transfer to manufacturing. We will discuss when the proper time is to implement design controls and what that means. We will discuss the necessary milestones / end points to move into the next phase of the process. We will discuss lessons learned that resulted in either good or bad outcomes from a failure to gain regulatory approval to spiraling costs and an inability to exist the V&V phase. We will discuss V&V strategies and use case studies as supporting examples of good and bad strategies.
Type: Master Class Conference
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