For organizations to consider more innovative solutions to improve outcomes, quality and safety, compliance must be a starting point not the end goal—seeking continuous improvement is the key to success. This journey begins when organizations understand their strengths and identify their areas for improvement. This is what ISACA’s Medical Device Discovery Appraisal Program (MDDAP) consistently enables enterprises to accomplish.
ISACA recently released An MDDAP Use Case: How a Medical Device Manufacturer Increased Production by 62% and Reduced Staff Turnover by 70%, a case study demonstrating a successful, real-life application of the program. In this blog, ISACA Now will provide a brief overview of MDDAP and highlight some of the positive takeaways from the use case.
What is MDDAP?
MDDAP is a tailored version of the Capability Maturity Model Integration (CMMI) framework and appraisal methodology. CMMI was created in the 1980s by the US Department of Defense in order to determine reliable and high-quality vendors that could be trusted with critical outputs. Through both academic and industry research, thousands of organizations were studied in order to pinpoint the desired behaviors that allowed them to meet goals, maintain their budget and perform with high quality. CMMI has since been adopted by thousands of organizations around the world.
In the same vein, MDDAP is adopted by device-makers to accelerate innovation and improve the quality of the products and services delivered to patients. By thoroughly understanding and measuring their capabilities, they can identify areas where improvements can be made. The US Food and Drug Administration (FDA), the Medical Device Innovation Consortium (MDIC), ISACA and industry launched the Case for Quality collaborative community Voluntary Improvement Program (VIP), leveraging MDDAP, that encourages and enables the medical device industry to continually improve the quality and safety of the devices and manufacturing processes.
Real Results from an MDDAP Use Case
In a recent use case, a medical device manufacturer examined two of their facilities, Unit A and Unit B. Both units had been successfully inspected and were performing well, but leadership had suspected that something was amiss at Unit B because of complaints from staff. Within a week of applying for VIP, ISACA met with the organization and assigned them an MDDAP Lead Appraiser, who evaluated how they do their work against CMMI best practices, allowing them to easily identify areas of strength and opportunities for improvement. The Unit was then empowered to prioritize the improvements that aligned with their business goals and shared their progress quarterly with the Lead Appraiser.
After a year had passed, Unit B had improved significantly from their first appraisal. According to the use case, “they increased their production capacity by 62 percent, reduced staff turnover by 70 percent, reduced time to identify root cause of issues by 90 percent and reduced complaints by a staggering 95 percent. Site leadership noted that the organization was motivated by the right reasons and was able to accelerate a substantial culture change. Their partnership with FDA also evolved for the better.”
For more details about how this organization achieved these results—including additional statistics, timelines, charts and visual appraisal comparisons—download the use case here. Find more about MDDAP on ISACA’s website to learn how your organization can understand, measure and improve outputs with quantifiable results.
