Case for Quality Collaborative Community transitions voluntary improvement program

The United States Food and Drug Administration (FDA), Medical Device Innovation Consortium (MDIC), ISACA, and medical device industry stakeholders developed the Case for Quality Voluntary Improvement Program (VIP) to shift medical device manufacturers’ mindsets beyond regulatory compliance and toward continuous improvement. After a pilot launch in January 2018, the Case for Quality Collaborative Community has now transitioned the VIP into a fully operational program.

The VIP leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP) which provides a model and method for device makers to measure their capability to produce high-quality devices for improved patient outcomes. The MDDAP framework is a version of the ISACA Capability Maturity Model Integration (CMMI) tailored specifically for this medical device industry program.

The VIP includes a multi-pronged approach: Combining MDDAP appraisals against a set of best practices, quarterly check points with performance reports, and a supportive regulatory environment. Together, this approach empowers medical device manufacturers to design, build, and deliver safe and innovative products to market faster.

In the supportive regulatory environment, participants were able to accelerate device improvement and time to market. Results reported by pilot participants include:

  • 4x capacity increase from improvements, changes resulting from appraisal
  • 65% increase in daily production
  • 27% decrease in time to close complaints
  • >$15 million in product sales
  • Shifting from tactical to strategic thinking
  • Identifying potential issues earlier, taking action before negative impact
  • Increasing rigor, predictability in new product development
  • Improving risk mitigation of nonconforming products, process control, supply chain

The fully operational program has formalized the collaborative oversight used through the pilot into an official Governing Committee. Iterative improvements and enhancements for the program are proposed through facilitated VIP working groups. This governance structure engages all stakeholders in seeking beneficial solutions by sharing information and ideas.