Medical Devices

Work Streams and Projects

The projects and outcomes of MDEpiNet will be firmly rooted in the tenets of public health, epidemiology and regulatory science.

Ongoing projects are organized among “work streams,” specific to a particular subject:


Methodology Work Stream

Evidence Synthesis - Novel Approaches to Enhance Post-market Evaluation of Medical Devices:

  • Evaluate selected medical devices based on public health importance/need and availability of existing data sources
  • Obtain safety and effectiveness estimates in the post-market setting
  • Develop and apply modeling techniques to enhance post-market surveillance
  • Translate the results of modeling for regulators, physicians and patients and disseminate the results

Patient-Centered Outcomes:

  • Adapt existing patient centered total product life cycle framework to evaluate selected medical devices
  • Account for comparator selection, device characteristics, operator characteristics, procedure/intervention characteristics, intervention setting characteristics, patient characteristics and appropriate outcome measures selection
  • Utilize appropriate statistical techniques to compare adverse events between comparator or exposure groups and translate the modeling results for regulators, physicians and patients and publicize the results

Infrastructure Gaps:

  • Evaluate existing gaps in approaches to medical device studies of approved medical devices by developing innovative methodologies using existing data sources and infrastructure
  • Identify and describe unique challenges and gaps in studying various classes of medical devices
  • Identify sustainable data and methods for evaluation of selected classes of medical devices

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Infrastructure Work Stream

FDA International Consortium of Orthopedic Registries (ICOR):

  • Work with ICOR registries to classify orthopedic medical devices
  • Develop new methodological approaches to implement and harmonize UDI information into meaningful attributes and characteristics

IDEAL -- Idea, Development, Exploration, Assessment, Long Term Study:

  • Develop infrastructure and methodology to integrate evidence throughout the total product life cycle
  • Lower barriers to clinical trial development and execution
  • Promote innovation in the development of medical devices

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UDI Work Stream

Roadmap:

  • Develop a detailed white paper and roadmap of tasks and potential hurdles to adopting a unique device identifier (UDI) based national medical registry

Unique Device Identifier (UDI) Demonstration:

  • Identify and describe the outcomes and patient populations, including specifications of applicable comparator or exposure groups of interest, for two cardiovascular device areas within an electronic healthcare record environment
  • Identify and describe the outcomes and patient populations, including specifications of applicable comparator or exposure groups, for three orthopedic device areas within ICOR

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Page Last Updated: 07/02/2014
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