MDIC Case for Quality Program - Product Quality Outcomes Analytics Working Group Report


Healthcare provider stakeholders, including physicians, clinicians and supply chain professionals utilize data to make procurement decisions for medical devices to ensure and improve patient access to high quality devices. The integrity of these decisions depends upon the accuracy and completeness of the underlying data. There are three (3) significant challenges to accurate and complete data on medical device quality:

  • Lack of unbiased, relevant, consistent and available data
  • Lack of consistently defined device quality dimensions, or applied analytical methods
  • Lack of secure process and operating model to build stakeholder confidence and enable individual companies to be fully transparent about product quality

The Medical Device Innovation Consortium (MDIC) Product Quality Outcomes Analytics project team is a multi-disciplinary group comprised of representatives from manufacturers, providers, FDA, and Value Analysis Committees (VACs). The team's objectives are to provide information about the feasibility and effectiveness of using publicly available data and to recommend analytic techniques to enable assessments of medical device product quality. Standardized medical device performance data and analytics could be utilized for comparative analysis by several stakeholders in order to improve procurement decisions and potentially improve patient outcomes.

Executive Summary
MDIC-facilitated discussions within the Medical Device industry ecosystem clearly show that stakeholders would benefit from access to medical device quality information in order to support purchase decisions that can potentially result in improved patient outcomes and better cost management. Yet there is no formal approach to measure and provide feedback to reward the market for quality. To address this gap, the Case for Quality Product Quality Outcomes Analytics (PQOA) team embarked on a pilot to determine whether cross-manufacturer comparative analysis of quality would be feasible and effective to support value analysis team purchase decisions. This pilot focused on knee and defibrillator implants. Voice-of-the Customer feedback was gathered through surveys and focus group sessions.

The project team developed and evaluated standardized definitions for Quality that included the following seven (7) domains:

  • Safety 
  • Effectiveness 
  • Reliability 
  • Patient Experience
  • Usability 
  • Availability 
  • Compatibility

Survey data showed that the vast majority of respondents (over 80%) thought these seven (7) domains defined medical device quality very well (59%) or pretty well but would add more domains (25%).

To evaluate if it is feasible to compare manufacturers across these domains using data and analytic techniques, the team contracted with a third-party. The subsequent dashboards developed during this effort were based on input from a multi-disciplinary group that included hospital Value Analysis Committees (VACs), manufacturers, regulators, industry SMEs and data scientists.

This report is a summary of the team’s observations and recommendations for the development of a formal approach to measure medical device product quality outcomes in order to provide feedback and reward the market for Quality. Recommendations included the need to improve data robustness as well as the need to develop an operating model that would enable data access and transparency for scale and sustainability in the future.


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