PMCF Case Study: Cook Medical

Compared to a traditional chart review, Cook Medical saved 60% in overall time, including a nearly 50% savings in FTE hours, using 3Aware aiSurveillance.

Project Overview & Results

3Aware engaged with Cook Medical, a major U.S.-based medical device manufacturer with an extensive portfolio developed over 60+ years, on a PMCF project for the Instinct PlusTM Endoscopic Clipping Device. With the aiSurveillance platform, along with 3Aware clinical scientist support, the Cook Medical team successfully collected data on each indication targeted.

3Aware aiSurveillance uncovered safety and performance data consistent with published prospective studies. Access to unstructured physician notes provided clarity regarding potential complications, adverse device effects and performance failures, and prevented misidentification of indication.

 

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Chart Review vs. aiSurveillance

A medium-sized retrospective chart review for 150 patients, across 3-4 sites, can easily cost upwards of $400,000 USD and require 12-18 months of time to complete. This is untenable as a long term PMCF strategy for many product portfolios.

3Aware aiSurveillance automates patient chart reviews for post-market analysis of pre-identified device-specific patient cohorts. AI-optimized repeatable analytic protocols and decision-making result in ever-increasing efficiency–allowing the same review of 150 patients to be completed in a fraction of the time and cost, compared to a traditional retrospective chart review project. In addition, a 3Aware subscription includes ongoing access for other studies.

Post-Market Surveillance Options for EU MDR

Medical device manufacturers–with the involvement of notified bodies–must declare compliance, for both new and established products, to the applicable requirements of the EU MDR. EU MDR post-market requirements involve the continuous collection of clinical data, and evaluation of safety and performance after a device has been placed on the market.

Manufacturers are required to develop and implement a post-market clinical follow-up (PMCF) plan as part of their post-market surveillance (PMS) program. PMCF is the proactive collection of clinical data, and activities may include:

  • Prospective or retrospective clinical studies
  • Patient registries
  • Surveys
  • Analysis of real-world data

How Does aiSurveillance Compare?

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About 3Aware

3Aware minimizes the cost, time and risk of MedTech compliance, using AI to automate severely under-automated, mission-critical PMCF processes in a challenging regulatory environment. The aiSurveillance-powered, PMCF-optimized clinical workbench empowers clinical scientists to immediately formulate cohorts and efficiently adjudicate events for regulatory compliance purposes.

  • 3Aware enables compliance at a fraction of the time, cost and risk of status quo approaches.
  • 3Aware data content currently covers tens of thousands of devices explicitly tied to the experience of millions of patients; and is consistently growing.
  • Proven AI capabilities facilitate the mining, interpretation and structuring of critical information buried in unstructured provider notes.
  • The 3Aware platform enables analysts to immediately and directly access the distilled content they need to apply their expertise—in a clinical workbench optimized for Post-Market Clinical Follow-up.

    Learn more at 3aware.ai.