Archives: Agenda

How it runs: A brief 10-minute “problem statement” is presented by the moderator, followed by a 30-minute collaborative “whiteboard” session where the group drafts a potential framework or solution. At the end each table will summarize their potential solutions.  

• Choosing when RWD can credibly support device regulatory questions
• Establishing data quality, provenance, and governance requirements
• Designing hybrid evidence packages combining trials and RWE

• Managing diagnostic and device complexity at site level
• Addressing sponsor–site misalignment early
• Practical tips for improving feasibility and retention

• Home Market Approval ≠ EU Readiness
• Can you reuse your clinical data and what to take care off?
• Clinical evidences is not a one time work… it is a lifecycle work under MDR

• Identifying where misalignment between clinical, regulatory, and commercial teams most commonly breaks down and delays submissions or launches
• Understanding which decisions need cross-functional alignment from day one to ensure evidence supports both approval and adoption
• Sharing leadership-level lessons on how to structure collaboration early to avoid costly rework later in development

Moderator

Jodi Lamberti, VP, Clinical and Commercial Development, Visura Technologies

Leveraging GlobalData’s proprietary medtech databases on clinical trials, investment and new product pipeline, Charlie will present an overview of what companies, products, indications, applications and geographies are experiencing the most growth. Major takeaways include:

• Detailed analysis on trends in medtech clinical trials at a global level over the last three years
• Highlights on new medtech products in early-stage development, especially those in the clinical trial phase
• Insights into recent patterns on grant funding, venture funding and equity investment into early stage medtech companies