case study
To assess global market landscape of non-clinical grade home monitors for Medical Device Company to empower patients for hypertension management and goal-setting.
  • Objective

    Customers and patients may purchase non-clinical grade home monitoring devices.
    Data from non-clinical grade devices inform and guide clinical decisions 
    Are there any consequences of using non-clinical grade devices for home monitoring?

  • Approach

    To review the consequences of using non-clinical grade devices for home monitoring
    Provide evidence on different non-clinical grade devices.
    Assess the clinical, economic, and humanistic consequence of errors. 
    Identify the relevant policies and research gaps for future real-world evidence studies.

  • Deliverables

    Guidelines, Regulations & Standards ISO for BP measurement by non-clinical grade devices
    Validation and Accuracy Studies
    Consequence of errors of using home BP monitoring devices
    Recommendation from literature

  • Outcome

    Identified relevant policies and research gaps for future real-world evidence studies
    Integrate a roadmap for client to establish manufacturing guidelines for validated and accurate home use devices.