Requirements for medical devices are evolving, making evidence-based decisions more relevant than ever, especially when it comes to proving safety, effectiveness, improved patient outcomes, and regulatory requirements. In addition, there is an increasing need to accomplish this more rapidly and with greater cost-effectiveness. This is where real world data (RWD) and linked data sources come into play. Some of the most pressing challenges include understanding patient profiles, treatment patterns, healthcare burden, and clinical outcomes in the real world environment.

Key Learning Objectives:

• Understand how RWE strategies can be used to support development needs in the medical technology arena, including research initiatives, market development, and reimbursement planning, using comparative effectiveness analyses.
• Review how rich data sources used in real world evidence studies (e.g., claims data, laboratory data, EMRs, etc.) can be used to support clinical evidence requirements.
• Explore how RWE studies can support regulatory affairs strategies to satisfy market approval requirements.
• Learn how linked/integrated data sources provide options to support evidence development requirements.
• Understand what is needed for success as it relates to the evolving MedTech regulatory landscape and how RWE is being used for regulatory decision-making.

Speakers

Mitch DeKoven, MHSA
Senior Principal, Health Economics and Outcomes Research, Real World Solutions, IQVIA

Michael Hull, MS
Associate Principal, Health Economics and Outcomes Research, Real World Solutions, IQVIA

Brinda Sriskantha, PhD
Global Portfolio Strategy Lead, Real World Evidence MedTech, IQVIA