ASC Program Pilot Study: Raising the Bar for Quality Standards in Medical Devices

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 Accelerate Sustainable Capability (ASC) pilot study, facilitated by MDIC alongside the FDA and industry partners, 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 program aims to enhance the safety, reliability, and trustworthiness of medical devices. Using an approach rooted in Capability Maturity Model Integration (CMMI), the ASC pilot 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 impacts, 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 program promotes a proactive, systematic approach to quality management. The study was designed not only to improve organizations’ QMS, like the 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, shared her experience with the ASC pilot: “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.” She added that the program provided a framework for participants to advance maturity in their quality management systems, 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 Pilot 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 remarked, “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 include: 

• 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 pilot 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 program enables organizations to strengthen their quality processes and prepare for long-term success. 

A Model for Industry-Wide Quality Improvement 

The ASC program provides a model that other organizations may consider, as 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, the ASC program may complement the existing Voluntary Improvement Program (VIP) as an on-ramp or parallel path, particularly for organizations focused on sustainable quality advancements. The ASC pilot demonstrated positive progress in improving organizations’ QMS and business process maturity, with participating manufacturers resolving open advisory actions following post-pilot re-inspections by FDA. With insights gained from this pilot, MDIC and its partners are positioned to further explore ways to support resilient quality systems across the medical device industry, with the potential to positively impact patient care.