Archives: Agenda

• 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

Regulatory approval is no longer the finish line—it’s just the starting point. In today’s MedTech landscape, clinical success alone doesn’t guarantee market survival. This session offers a lifecycle-driven blueprint that integrates clinical, regulatory, reimbursement, and market strategy from the start. Through real-world cases and usable frameworks, you’ll learn how to build devices that get adopted, paid for, and scaled. In this session we will explore:

• How clinical trial design can sabotage reimbursement success and how to fix it
• A blueprint for integrating clinical, regulatory, and market access planning
• Real-world examples where lifecycle thinking saved or doomed devices
• A checklist for building lifecycle-centric strategies from day one
• A high value bonus handoutwill be provided to those who attend the talk

• Assessing the impact of recent U.S. policy changes on the FDA’s effectiveness and medical device regulation
• Navigating international relations and potential WHO disengagement in shaping global regulatory alignment and CE mark recognition
• Understanding the broader implications for community-building and industry collaboration amid shifting geopolitical and regulatory landscapes

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

Panelists
Divya Raman, Senior Director of Policy, Intelligence, and Strategy, Teleflex
Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific

• Unique characteristics of MLMDs to consider
• Exploring MLMD-related threats and their implications for patient safety
• Current standards landscape & future projects

• 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