The Secret to a Successful Product Launch: - Emerson Consultants ...

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Regulatory Affairs Navigate the FDA process Ensure product approval/clearance Import/export requirements Biocompatibility, preclinical & engineering test requirements Determine indications for use Relevant standards & guidance Copyright Emerson Consultants, Inc. 2011 14
Clinical Research Produce clinical data to support regulatory submissions Ensure study endpoints are satisfied Develop studies to support “substantial clinical improvement” and “comparative effectiveness” Determine components of the clinical strategy to support intended use for FDA and payers Copyright Emerson Consultants, Inc. 2011 15
Page 1 and 2: The Secret to a Successful Product
Page 3 and 4: Objectives Understand why it is cri
Page 5 and 6: Why the Need to Integrate Strategie
Page 7 and 8: Questions to Ask What does the FDA
Page 9 and 10: Questions to Ask Can the technology
Page 11 and 12: Questions to Ask What is the compet
Page 13: “A” Team REGULATORY AFFAIRS CLI
Page 17 and 18: Marketing Create procedure awarenes
Page 19 and 20: Product Development Phases Phase I:
Page 21 and 22: Copyright Emerson Consultants, Inc.
Page 23 and 24: Phase I:Conceptualization Key integ
Page 27 and 28: Phase II: Verification Milestones:
Page 29 and 30: Develop Clinical Protocol Protocol
Page 33 and 34: Phase III: Validation Milestones Co
Page 35: Payer Value Proposition Validate to
Page 38 and 39: Phase IV: Commercialization Key Int
Page 40: Key Functional Group Activities by
Page 46 and 47: Final Thoughts… “Integration”
Page 48 and 49: Thank You Kelli Hallas Executive Vi

The Secret to a Successful Product Launch: - Emerson Consultants ...

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