By Kim Kaplan, Senior Product Manager, ISACA

Device manufacturers increasingly recognize that compliance with regulations as an end goal vs. a starting point does not necessarily translate to device quality.

By driving toward a culture of continuous improvement beyond compliance, ISACA’s Medical Device Discovery Appraisal Program (MDDAP) is helping to advance device quality and patient outcomes.

MDDAP provides the model of best practices and appraisal method leveraged by the Voluntary Improvement Program (VIP), the first Case for Quality initiative recognized by FDA that offers participants regulatory opportunities to accelerate improvements to device quality and manufacturing.

As Kim Kaplan, senior product manager for MDDAP at ISACA, recently said, “MDDAP is a tailored version of CMMI that enables medical device manufacturers to better understand, measure and improve their capabilities to deliver high-quality products to patients.”

Based on years of post-appraisal survey data, participants generally proclaim that MDDAP improves product quality in several key areas, including:

• Communication
  • Improved alignment of objectives across company
  • Better knowledge of what product quality is and how to produce it with new ideas and perspectives
  • Common language across teams, better sharing of information and access between departments, ability to get the right people together
  • Predictable communication pathway for escalations with faster resolution of needs
  • Standardized reporting metrics, higher understanding of measurement systems, and tracking mechanisms that support accountability
• Shift from Reactive to Proactive
  • Roadmap toward anticipating and preventing both delays and nonconforming products
  • Stronger ability to make corrections before errors become a nonconformity
  • Improved risk mitigation of nonconforming products, process control, and supply chain
  • Increased rigor around training and understanding processes
  • Agility in decision making
• Culture
  • New focus on continuous improvement and a quality culture
  • Moving from the mindset of a start-up to a mature company
  • Pursuit of systemic changes rather than only addressing the problem at hand
  • Choosing to tackle projects with lasting benefits
  • Shifting from tactical to strategic thinking
  • Increased customer satisfaction
  • Recognition that everyone contributes to quality

To underscore the difference between focusing on compliance vs. quality, George Zack, principal and co-founder at Two Harbors Consulting, LLC and MDDAP appraiser, puts it this way: when his 16-year-old son had just earned his driver’s license, he was compliant with meeting state requirements by passing the mandatory exam, but characterizing him as a quality driver at that moment would have been misleading.

MDDAP appraisals allow device manufacturers to have the transparent conversations – whether within their site or in collaboration with other stakeholders – to improve their performance. An overwhelming 95%+ of program participants report that the appraisal provided value to their organization, and 85%+ indicate the appraisal method provided a direct value to improving product quality.

“The way we approach MDDAP appraisals is not to get a certificate, it’s to collect information on how your organization can be better,” Zack said. “Taken in that spirit, I’m not surprised at those percentages because people see value in the approach.”