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 the mindset of medical device manufacturers 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 from a pilot into a fully operational program.
The VIP leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP) which provides a model and method by which device makers can measure their capability to produce high-quality devices with the goal to improve patient outcomes. The MDDAP framework is a version of the ISACA Capability Maturity Model Integration (CMMI) that has been tailored specifically for this medical device industry program.
The VIP includes a multi-pronged approach: a combination of annual 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 VIP, an experienced appraisal team evaluates an organization’s capabilities through conversations with individual contributors, systems demonstrations, and site tours. The results are then synthesized for the organization to easily identify areas of strength to reinforce and prioritize opportunities for improvement.
The VIP is a continuous improvement method designed to help the Collaborative Community understand how to develop better quality and outcomes, both within an organization and across industry. Information is collected during an appraisal to evaluate how work is actually performed, highlight capabilities and activities that add value, and drive discussions that align and prioritize opportunities with business performance objectives.
In the supportive regulatory environment, participants were able to accelerate device improvement and speed to market. Results reported by pilot participants include:
- Capacity increased by 4 times due to improvements and changes resulting from the appraisal
- 65% increase in daily production
- 27% decrease in time to close complaints
- Greater than $15 million in product sales
- Shifting from tactical to strategic thinking
- Identifying potential issues earlier, taking action before negative impact
- Increasing rigor and predictability in new product development
- Improving risk mitigation of nonconforming products, process control, and supply chain
The fully operational program has formalized the collaborative oversight used through the pilot into an official Governing Committee which includes members of MDIC, FDA, and industry, with ISACA and relevant collaborators serving as advisors. Iterative improvements and enhancements for the program are proposed through facilitated VIP working groups. This governance structure engages all stakeholders in seeking beneficial solutions through the sharing of information and ideas.
“We are excited that the VIP, which utilizes ISACA’s MDDAP, is now transitioning to a fully operational program. This allows better medical devices to be innovated faster and at lower costs,” says Nader Qaimari, ISACA Chief Product Officer. “ISACA is proud to have a hand in driving sustainable improvements for medical device quality, in turn offering better patient safety outcomes.”
To learn more about MDDAP, visit www.isaca.org/mddap.
ISACA® (www.isaca.org) is a global professional association and learning organization that equips individuals with knowledge, credentials, education and community to progress their careers and transform their organizations, and enables enterprises to train and build quality teams. It has a presence in 188 countries, including more than 220 chapters.