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

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Why the Need to Integrate Strategies? Work smarter Consistent approach-lay groundwork for future projects and create efficiency Reduce internal costs Expedite approval Generate revenue faster Gain market acceptance Become market leader Copyright Emerson Consultants, Inc. 2011 4
Why the Need to Integrate Strategies? Clinical protocol critical to reimbursement, regulatory, and marketing success Needs of FDA, CMS, and the market are different but a well-designed study can incorporate all these stakeholder’s needs Most importantly, in today’s healthcare environment a company cannot successfully bring a product to market on a project-by-project basis Copyright Emerson Consultants, Inc. 2011 5
Page 1 and 2: The Secret to a Successful Product
Page 3: Objectives Understand why it is cri
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 and 14: “A” Team REGULATORY AFFAIRS CLI
Page 15 and 16: Clinical Research Produce clinical
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

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