Archives: Agenda

• 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

• Digital patient engagement tools drive compliance: a web-based electronic patient-reported outcome platform together with an automated reminder system and multi-device accessibility enabled 98% of participants to complete visits with minimal follow-up, demonstrating how digital tools can engage diverse patient populations, including older demographics, while reducing site workload
• Integrated electronic payment system eliminates barriers: connecting an ePRO platform with digital payment solutions through API integrations ensures immediate participant compensation with multiple payment options (PayPal, Venmo, direct deposit), achieving 97%+ payment claim rates and preventing the participant dropout issues common with traditional prepaid card systems

• Translating cybersecurity expectations into clinical risk and user impact
• Planning evidence for resilience claims and update pathways
• Preparing submission-ready documentation and traceability