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

More documents

Recommendations

Info

Phase II: Verification Key Integrated Activities Update individual strategies Monitor market changes and competition Establish bench test requirements and test plans Develop risk management plan Pre-clinical studies Develop clinical protocol Build relationships with key stakeholders Establish clinical trial reimbursement Select investigators Develop study budget Develop patient recruitment plan Develop publication strategy Copyright Emerson Consultants, Inc. 2011 28
Develop Clinical Protocol Protocol Summary Example Ablation Device for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation Purpose Primary Study Objective To compare the safety and effectiveness of the Ablation Device to antiarrhythmic drugs (AAD) in the treatment of atrial fibrillation To demonstrate that the Ablation Device is more effective than medical management with AADs, with an acceptable safety profile, for treating patients with symptomatic Paroxysmal Atrial Fibrillation (PAF) who were refractory or intolerant to AAD therapy. Study Design A prospective, randomized, controlled, multi-center study, involving up to 200 subjects. Patient Population Key Inclusion Criteria: 1. Patients with symptomatic PAF who had 3 AF episodes in the 6 months prior to randomization 2. Failure of at least one AAD 3. Age 18 years or older Copyright Emerson Consultants, Inc. 2011 29
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 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: Phase II: Verification Milestones:
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 ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?