Continuously Enhancing Patient Safety is Everyone’s Responsibility

An enterprise culture of continuous quality improvement, cultivated by strong leadership, not only serves as a clear competitive differentiator but also builds confidence among regulators and users. The Voluntary Improvement Program (VIP) was developed in collaboration with FDA, MDIC, ISACA and the medical device industry as part of the FDA’s case for quality initiative. The program helps device makers enhance patient safety and optimize business performance while reducing costs associated with inefficiencies and quality challenges.

Device manufacturers participating in VIP continuously demonstrate improved product safety, increased speed to market, operational savings, enhanced revenue opportunities, and where applicable, decreased regulatory burdens.

Voluntary Improvement Program Journey Map

 

VIP Enables Device Makers to Cultivate a Patient-first Organizational Culture Focused on Operational Excellence

“The program has enabled us to establish new relationships with peer companies for sharing of best practices, while also strengthening our relationship with FDA. And significantly, it has given our participating sites access to the impactful regulatory benefits that this program offers– which in turn benefits our patients and customers around the world.”

Program Participant

Start Your Journey

Reported Value from Sustained VIP Enrollment

Systemic Downward
Recall Trend

Patient Access

Patient Safety

Cultural Changes

Continuous Improvement Savings

Coaching to Improve

VIP Participants Experience:

  • 62% increase in daily production
  • 70% decrease in staff turnover
  • 90% reduction in time to ID root cause
  • 95% reduction in complaints per million
  • 27% decrease in the time taken to close complaints
  • Almost 900 more high-risk patients receiving life-saving treatment
  • 4x increase in manufacturing capacity
  • $15M+ in additional sales resulting from operational improvements
  • $286K Annual savings
Futuristic Machine Engine Development Engineer Working on Computer at His Desk, Talks with Female Project Manager. Team of Professionals Working in the Modern Industrial Design Facility

Hear about the Transformative Power of VIP from ISACA's Simona Rollinson and MDIC's Joe Sapiente

Consider VIP to Gain:

  • Greater return on equity and brand loyalty.
  • Treating quality as a competitive advantage.
  • Shifting from compliance-focused to continuous improvement mind-sets.
  • Increased employee engagement, decreased turnover, and higher morale from a more integrated quality culture
  • Faster market access and product availability
  • Risk reduction through improved processes and capabilities
  • More integrated quality culture, increased employee engagement, decreased turnover, and higher morale
  • Proactively improve areas that are most impactful and business goals relevant, instead of responding to compliance remediation
  • Increased rigor and predictability in new product development and release
  • Shift from tactical to strategic thinking

Voluntary Improvement Program Partners