Archives: Agenda
Responsibly leveraging AI and real-time data in post-market surveillance
- AI in the post-market surveillance landscape
- How AI might enhance risk management
- Regulatory considerations: presenting AI data in submissions
Morning Refreshments & Networking
Live Virtual Session with Q&A: Reimbursement strategies in medical device clinical trials: bridging regulatory and payer expectations
- 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
NASA’s James Webb Space Telescope: lessons for health care from the edge of time
- 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
Registration and refreshments
Chairperson’s opening remarks
Approved and abandoned: why 90% of devices die without lifecycle strategy
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
PANEL DISCUSSION The intersection of geopolitics, U.S. health policy, and the medical device industry
- 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
Cybersecurity in machine learning medical devices (MLMD): new threats and vulnerabilities
- Unique characteristics of MLMDs to consider
- Exploring MLMD-related threats and their implications for patient safety
- Current standards landscape & future projects