Archives: Agenda

• Exploring the impact of reduced medtech investments and cost-cutting strategies
• Trends in outsourcing and supplier consolidation to reduce overheads
• Encouraging innovation despite financial pressure

Moderator
Dave Ribble, Medical Devices Expert, GlobalData

Panelists
Al Crouse, VP of Quality Assurance and Regulatory Affairs, CVRx
Sameer Kumar, Chief Executive Officer, HabitAware Inc

• The sponsor’s role in building successful CRO collaborations
• Best practices that form productive sponsor-CRO relationships
• Overcoming sponsor-CRO challenges
• Managing sponsor expectations and optimizing interactions

• Exploring how combination products are regulated
• How to determine the primary mode of action (PMOA)
• Capturing and maintaining critical data points
• Challenges and best practices

• AI in the post-market surveillance landscape
• How AI might enhance risk management
• Regulatory considerations: presenting AI data in submissions

• JWST’s missions will be introduced, and its architecture discussed
• Highlighting JWST’s engineering challenges and connections to high-reliability healthcare technologies
• Exploring fault-tolerant design and testing in space and medical devices
• Discussing JWST-inspired lessons in the development of completely novel systems
• Examining JWST’s risk management approach and its application to other high reliability missions

• Incorporating reimbursement objectives into trial design and evidence development
• Recognizing the gap between regulatory approval and insurance coverage
• Utilizing reimbursement expertise to align strategies across stakeholders
• Prioritizing early engagement with payers to define evidence expectations