(Aristotle) Market Entry 1 2 Pre-CE-mark - - PowerPoint PPT Presentation

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Aug 26, 2022 111 likes •260 views

You cannot direct the wind, but you can adjust the sails (Aristotle) Market Entry 1 2 Pre-CE-mark Post-CE-mark Standard of Care Clinical Step 3 Observational Clinical Step 2 Studies Randomized Real

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You cannot direct the wind, but you can adjust the sails (Aristotle)

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Preclinical Clinical Step 1 Prospective Studies  Safety Clinical Step 2 Randomized Control Trials  Efficacy Clinical Step 3 Observational Studies  Real Life Standard of Care

Source: Malchau H. Introducing new technology: a stepwise algorithm. Spine (Phila Pa 1976). 2000 Feb 1;25(3):285.

Pre-CE-mark Post-CE-mark 1 2 Market Entry

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apply apply apply

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apply apply participate apply participate

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Approach Key

pinion leaders

(KOL)  for advice on clinical program Approach show and work horses (Hospitals)  to build Centers of Excellence Include Medical Societies‘ Workgroup Members  to develop position papers and act as experts for G-BA / IQWIG Include Medical Societies‘ DRG committee members  to apply for reimbursement changes at InEK / DIMDI

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