Evidence is an essential component of effective market access for medical technologies and in-vitro diagnostics. Unlike pharmaceutical industry, medical device manufacturers do not invest into large randomized controlled trials, and very typical design for medical devices is case series study. However, with further strengthening reimbursement/HTA framework in majority of European countries, evidence become more and more important for acceptance of technology by relevant stakeholders.

Synergus can provide support in analyzing evidence requirements for technology and contributing to evidence generation strategy. Usually, we perform analysis from perspective of different stakeholders:

  • Reimbursement/HTA authorities
    • In analysis we look into general evidence requirements of reimbursement/HTA programs and review examples of accomplished evaluations to understand evidence requirements
    • Often payers may introduce requirements for clinical studies/registries after granting reimbursement for technology. This is also taken into account for evidence generation strategy
  • Clinical societies
    • Endorsement of technology by clinical societies is essential for market access. Analysis includes review of available clinical guidelines to identify evidence gaps for technology or similar technology area
  • Medical community
    • Unlike clinical societies, practicing physicians may have different opinion about required evidence (usually – lower level of evidence). Through interviews with opinion leaders in different countries we can map requirements for acceptance of novel technology by clinical community
  • Competitive landscape
    • It is essential to understand, what competitive companies are doing in terms of evidence development, so you can adjust evidence generation strategy accordingly. Very often, understanding of evidence status and developments for competitors is needed, if customer wants to gain leadership in the area

If evidence development strategy is developed in parallel to reimbursement analysis/strategy, both strategies are matched, so customer can more effectively plan introduction of product to markets with specific evidence requirements.

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