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

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 Life Clinical Step 1 Control Trials Prospective  Efficacy Preclinical Studies  Safety Source: Malchau H. Introducing new technology: a stepwise algorithm. Spine (Phila Pa 1976). 2000 Feb 1;25(3):285.

• • – – • – • – – • – • • •

• • •

apply apply apply

apply apply participate apply participate

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

• • •

• • – • • – – • • • •

• • • • • •