Safe Space Project Team Seeks Industry Input on Post-Market Signal Management Practices

The Medical Device Innovation Consortium (MDIC) Safe Space Project Team is seeking input from across the medical device ecosystem to better understand current practices, challenges, and opportunities in complaint management and post-market safety surveillance.

Through a new industry assessment, the team aims to establish a baseline understanding of how organizations are implementing standardized safety data practices, including International Medical Device Regulators Forum (IMDRF) coding, and exploring the use of artificial intelligence (AI) in post-market safety signaling and surveillance.

Established in 2020, the MDIC Safe Space Project Team brings together manufacturers, solution providers, regulatory stakeholders, and healthcare providers to address shared medical device challenges, advance industry practices, and improve patient safety.

The team’s recent work has focused on modernizing medical device recall and field action communications. Its Pilot Study Report on Modernizing Recall Notifications demonstrated the potential for digital approaches to improve response rates, response times, consistency, and usability.

Building on these findings, the team developed best practices to support more standardized, digital-first recall communications and continues to advance guidance on field action requirements.

The Safe Space Project Team is now expanding its work to complaint management and post-market safety practices. This survey is intended to establish a baseline understanding of current practices, challenges, and opportunities across the medical device ecosystem. 

Stakeholder feedback will help the team: 

• Assess current IMDRF coding utilization, adoption, and implementation challenges. 
• Identify successful adoption strategies and indicators of organizational maturity. 
• Inform practical recommendations, implementation frameworks, and adoption guidance. 
• Better understand current approaches to AI-enabled safety signaling and surveillance. 
• Identify common barriers and emerging practices related to AI and data readiness, including governance and resource needs. 

The insights gathered will help inform practical resources and recommendations designed to strengthen complaint management, safety surveillance, and industry-wide adoption of effective practices.