Medical Device Clinical Research

& Reimbursement Conference

Understanding the Complex Nature of Conducting Medical Device Studies that Support Regulatory and Reimbursement Goals in a Cost and Time Effective Manner

January 11-12
Phoenix, Arizona

About the Conference

This conference program will bring together executives from industry to discuss and debate the challenges that they face in designing and conducting studies that support an increasing array of corporate goals. Keynote presentations will address topics of interest to clinical and reimbursement executives, on movements within the industry resulting in new evidence thresholds, as well as methods for bringing teams together throughout the product lifecycle to ensure targets are met.

Each afternoon, the audience will divide into break-out sessions that will focus more specifically on topics related to clinical research or reimbursement

Topics to Include:

General Sessions

• Understanding the Impact of Changes in Health Policy on Evidence Requirements for Medical Devices
• Comparative Effectiveness Studies Impacting Medical Devices
• Understanding Coding Principles from the Clinical Research Perspective

Clinical Study Breakouts

• Optimizing Site Selection through working with Sales, Marketing and KOL’s
• Ethical and IRB Considerations in Subject Enrollment
• Understanding Pathways for Working with FDA to Secure Device Approval
• Opportunities in Post-Marketing Clinical Research

Reimbursement Breakouts

• Developing End points to Support Reimbursement in Post-Marketing Studies
• Preparing for and Understanding Health Technology Assessments
• Recognizing Differing Evidence Requirements for Private vs. Public Payers