Global MedTech Europe Solution

Polaris delivers innovative technology and expert consulting that will help you be compliant with new Global MedTech Europe regulations that go into effect on January 1, 2018.

Innovative Technology

Polaris’ Global MedTech Europe technology solution provides a scalable, flexible and easy-to-use system that will help you ensure that your organization is compliant with Global MedTech Europe requirements. Our tool provides unparalleled functionality and usability, including:

An external facing portal that HCOs can leverage to submit requests

An internal facing portal that can be leveraged to manage the end to end process:

  • Enter request (if not already done externally)
  • Ability to select type of HCPs that are eligible
  • Review and approve requests, using objective criteria
  • Generate an electronic contract based on pre-entered values
  • HCOs can sign digitally and attach contract to the request
  • Generate the transparency report in the format as defined by Med Tech Europe
  • Configure solution and report for future changes
  • Create the CVS report to pre-notify the education grants and donation
  • Post event transparency reports

Polaris’ innovative technology provides end-to-end solutions:

Workflow-based capture

  • Robust, customizable processes for capture, approval and payment
  • Consulting Arrangements
  • Speaker Arrangements
  • Investigator Initiated Studies/Clinical Trials
  • CME/Charitable/Sponsorships/Exhibits

Reporting, disclosure, feedback, monitoring and alerts

  • Configurable reporting rules engine, substantially reducing cost to maintain and operate
  • Automatic updates to required reports when reporting requirements change
  • All spend consolidated to unique HCP/O profiles
  • Compliance reports to validate and submit for
    disclosure — validation of data entry
  • Ad hoc, user generated capabilities to slice and dice aggregate spend data attributes for additional reporting purposes available at no extra cost
  • Pre-defined dashboards and snapshots of HCO/P spend
  • Upstream publishing of spend details to spend capture source systems and enterprise data warehouse systems
  • Alerts to monitor spend caps and thresholds
  • Approval processing before spend is incurred

Download the Polaris Global MedTech Europe Solution fact sheet now.

Our Global MedTech Europe solution integrates seamlessly with your existing IT landscape:

Integrated and spend capture

  • Integration of non-Polaris captured spend
  • Accounts Payable (SAP/Oracle/JDE)
  • Meeting Logistics, and third party vendors and partners
  • Clinical Research Organizations

Travel and expense capture

  • Integration of T&E system (i.e., Concur) through
    standardized intake
  • Focus on defaults and enhancements required
    for aggregate spend granularity
  • Defined process for resubmissions and changes

Customer master integration

  • Enterprise source of validated HCP/O profiles
    and unique identifiers
  • Match/merge capabilities to avoid duplication

Guidance and Expert Insights

Our technology solutions are informed by robust subject matter expertise and supported by our risk and process consulting services.

Our industry-leading consultants can help to ensure compliance with the new regulations as well as process optimization based on our breadth of experience in working with many large, as well as emerging, medical device companies:

  • Compliance risk management services, including risk mitigation associated with the introduction
    of the new member company requirements and tactical
    planning for their implementation
  • Deep expertise in global transparency process design,
    implementation and ongoing support
  • Complete process design support and guidance, including:
    • Best practice guidance focused on key activities   such as medical education, scholarships and charitable donations
    • Policy and SOP drafting
  • FMV benchmarking methodology, data and ongoing
    assessment support for interactions with HCO that have
    been implemented effectively by device companies across
    Europe

Polaris’ experts can work with you to make sure you and your organization are ready for the January 1, 2018 deadline.

Download the Polaris Global MedTech Europe Solution fact sheet now or contact us today.