(MDIC: Arlington, VA) -- Medical Device Innovation Consortium has developed a new report in collaboration with the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, Zimmer Biomet, Medtronic, and other leaders in the medical device industry, the Accelerate Sustainable Capability (ASC) Pilot Study.

The medical device industry is fundamental to global health, providing tools and technologies that support patient care and save lives. Upholding rigorous quality and compliance standards within this sector is a complex, ongoing challenge that requires adherence to regulations and a commitment to continuous improvement. The ASC study explores a strategic approach to strengthening quality management systems (QMS) with a focus on sustainable, long-term enhancements.

By examining the foundational structures of QMS, the ASC study aims to enhance the safety, reliability, and trustworthiness of medical devices. Using an approach rooted in capability maturity model integration (CMMI), the ASC study provided manufacturers with tools to evaluate and improve their QMS and related processes. This method moves beyond conventional compliance checks, providing a collaborative framework that allows manufacturers to address regulatory compliance gaps while fostering more resilient quality practices. Early results show positive effects, with participants seeing enhancements in both process efficiency and product outcomes.

Building quality that lasts

Unlike conventional compliance efforts that may target isolated issues, the ASC study promotes a proactive, systematic approach to quality management. The study was designed not only to improve organizations’ QMS, like the Voluntary Improvement Program (VIP), but also to offer a structured pathway for addressing compliance findings in a way that supports overall business process maturity. By encouraging organizations to assess their QMS holistically, the ASC pilot helped manufacturers identify areas where they could make durable enhancements that positively influence product quality and patient safety.

Kathryn Merrill, quality/regulatory program director at Medtronic, says, “It was exciting to be part of a team of MDIC and industry members all focused on bringing high-quality products to patients. Over the past seven years, I have seen VIP achieve tangible quality benefits for organizations pursuing continuous process improvement above and beyond compliance. The ASC pilot aimed to explore whether a similar approach could support sites facing quality challenges while also bolstering their business processes.”

Merrill says the program provided a framework for participants to advance maturity in their QMS, leading to noticeable improvements in organizational performance.

The ASC study provided manufacturers with structured support, including action plans, quarterly checkpoints, and expert guidance, enabling manufacturers to close open advisory actions more effectively and achieve sustained compliance alongside quality improvements.

Key findings and impact

Seven manufacturers participated in the ASC study, each sharing unique insights and challenges. The program encouraged a shift from reactive compliance to proactive quality improvement, producing measurable outcomes. A site participant says, “Where we ended up arriving, in terms of big levers for improving issues, was surprisingly different from what we would have guessed if we had started purely from a compliance mindset.”

Key outcomes from the study:
• 91% of participants agreed that the ASC approach aligned with their quality management goals, highlighting its relevance to real-world quality challenges.
• 79% indicated that the program helped uncover opportunities to improve product quality, supporting ongoing improvement.
• Participants reported a 30% reduction in compliance resolution time, suggesting the program’s potential to reduce resource demands.

The study effectively demonstrated that a program focused on sustainable compliance, strong business systems, and continuous improvement could have far-reaching benefits within the medical device industry. By emphasizing foundational elements within QMS and providing a pathway to address compliance gaps collaboratively, the ASC study enables organizations to strengthen their quality processes and prepare for long-term success.

A model for industrywide quality improvement

The ASC study provides a model that other organizations may consider because it addresses essential aspects of compliance and quality management. Implementing this model could help organizations enhance their quality systems and adopt a more proactive approach to managing compliance requirements.

Based on the study’s findings, ASC may complement the existing VIP as an on-ramp or parallel path, particularly for organizations focused on sustainable quality advancements. The ASC study demonstrated positive progress in improving organizations’ QMS and business process maturity, with participating manufacturers resolving open advisory actions following post-pilot reinspections by the FDA. With insights gained from this study, MDIC and its partners are positioned to further explore ways to support resilient quality systems across the medical device industry, with the potential to improve patient care.

You can download the ASC study here.