How to demonstrate the clinical and/or organizational benefits of my solution

The 7 right questions to ask yourself :

  1. Are similar devices reimbursed? If so, how does my DM differ from competitors?
  2. What data is available? Are they specific to my product & relevant?
  3. What are the indications claimed?
  4. What is the comparator to propose?
  5. For a DMN: what is the clinical and/or organizational impact? For a LPP listing: what is the level of improvement expected service (ASA)?
  6. For certain cases: what is the organization of care around my device?
  7. What is the target population (volume of patients concerned)?