Archives: Agenda

• Navigating global and domestic trial complexities by adapting to regional regulatory landscapes and healthcare systems
• Optimizing site selection and patient recruitment by balancing global expansion with local engagement strategies
• Building strong CRO and vendor partnerships by ensuring alignment on trial objectives and performance expectations
• Streamlining trial processes by leveraging digital tools, real-time monitoring, and risk-based management approaches

• Navigating MDR complexity with intelligent EDC solutions

• Enhance data quality for faster CE marking
• Dynamic study management: flexibility & patient engagement

This session will showcase effective, tech-driven approaches to improving complex clinical workflows.

• Demonstrating how innovative tools reduce workflow friction
• Showcasing case study data across dynamic, multi-stakeholder clinical workflows
• Highlighting methods for optimizing project delivery through centralized platforms
• Streamlining patient eligibility review processes
• Enhancing remote monitoring with integrated solutions
• Leveraging a single collaboration platform for complex data exchanges and coordination

Our sixth annual medical device industry report surveyed over 500 professionals, revealing the current landscape of challenges, opportunities, and goals facing medical device companies. This session highlights key findings, including:

• Pre-market companies overestimate time-to-market (predicting 3.7 years for Class II and 6.6 years for Class III, while actual timelines are 2.7 and 4.6 years).
• Post-market companies spend over 52 hours monthly on reactive remediation, significantly more than the 17 hours pre-market.
• 50% of post-market companies identify project management and timeline risks as their top new product launch challenge.
• Ensuring data integrity and compliance throughout clinical trials
• Addressing data errors, regulatory risks, and inefficiencies to accelerate innovation with Greenlight Guru

• Ensuring ethical AI use by considering patient rights, informed consent, and the responsible integration of AI in clinical trials
• Mitigating bias in AI datasets by identifying sources of bias, improving data diversity, and implementing fair AI practices
• Promoting accountability and transparency by establishing clear oversight, understanding algorithm decision-making, and maintaining regulatory compliance

Moderator
Cathrine Longworth, Editor-in-Chief, Healthcare, GlobalData

Panelists
Mac McKeen, Adjunct Professor, University of Minnesota
Ivan Pandiyan, Executive – R&D, Product, Program, Digital/ AI Transformation, GE Healthcare
Tarek Haddad, Senior Director AI Research, Medtronic

This session focuses on regulatory strategies that enable the continuous improvement of AI algorithms in clinical applications. We will examine the Predetermined Change Control Plan (PCCP) approach and FDA methodologies to ensure compliance while maintaining innovation.

Key Topics:

• Understanding the PCCP approach – how it facilitates AI updates while ensuring regulatory compliance
• Best practices for AI algorithm updates – methods for maintaining performance, safety, and clinical efficacy
• Case studies – real-world examples of AI regulatory approvals and iterative updates in clinical settings

• Addressing complexities of European market access frameworks
• Leveraging EU MDR compliance to optimize market entry
• Integration of local and global market strategies
• Collaborative approaches to overcome regulatory and funding barriers

Moderator
Dave Ribble, Medical Devices Expert, GlobalData

Panelists
Divya Raman, Senior Director of Policy, Intelligence, and Strategy, Teleflex
Jason Neff, Senior Principal Scientific Affairs Specialist, AtriCure
Lisa Griffin Vincent, Chief Regulatory, Quality, Clinical Officer, GT Metabolic