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

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Questions to Ask….. Is it a New Technology? First to market What are the indications for use? Align with existing codes/coverage decisions What is the site of service? Safety Different reimbursement rates/methods Class l, ll, or lll What is the clinical data requirement? FDA CMS or other payers Societies Market Copyright Emerson Consultants, Inc. 2011 6
Questions to Ask What does the FDA Guidance Document require? Example: Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies (draft guidance March 2008) FDA encourages study sponsors to use the pre-submission process to gain informal feedback on proposed clinical protocols for DES, including feasibility or pivotal studies. Study design may be superiority or non-inferiority End points: death, MI, Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), stent thrombosis) How does FDA guidance document impact reimbursement? VBRs and IBDs with allograft One on label and one off label Payers will not cover and pay for off label use Marketing cannot promote Copyright Emerson Consultants, Inc. 2011 7
Page 1 and 2: The Secret to a Successful Product
Page 3 and 4: Objectives Understand why it is cri
Page 5: Why the Need to Integrate Strategie
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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