Archives: Agenda

• 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

• Comparing validated use cases across feasibility, monitoring, and documentation
• Defining guardrails for privacy, bias, and human oversight
• Identifying where AI adoption increases risk more than it reduces work

Moderator

Peter Horwich, President, Lot 10