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.

The use of real world evidence (RWE) to support market access decisions, reimbursement strategies, and comparative effectiveness has become increasingly imperative and far-reaching in the last several years. Various data assets, such as medical and prescription claims and electronic medical records (EMR), provide a rich resource in support of clinical evidence development across the medical technology industry.

In this webinar, IQVIA experts will focus on the medical technology (MedTech) environment, examining how and why RWE is imperative and should be leveraged early in planning stages. The speakers will explore ways in which RWE studies can provide meaningful support for research, marketing, clinical, regulatory decision making, and reimbursement requirements.

The presentation will be of most interest for those in the medical device, diagnostic, and equipment space, with roles related to medical affairs, HEOR, regulatory, reimbursement, or RWE.

Share this invitation with a colleague, and we look forwarding to seeing you there!

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.

Featured Speakers

Mitch DeKoven, MHSA

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

As Senior Principal, Health Economics and Outcomes Research at IQVIA, Mitchell DeKoven leads teams in a variety of health economics and outcomes research projects, including value development plans, retrospective database studies, and observational surveys. DeKoven sits on the editorial advisory boards of several publications such as Journal of Comparative Effectiveness Research. He has also published over 40 peer-reviewed journal articles. DeKoven received a Master of Health Services Administration from the University of Michigan, and a bachelor’s degree in Spanish from Washington University (St. Louis).

Michael Hull, MS

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

Michael Hull is an Associate Principal on IQVIA’s Real World Solutions team. He has conducted research in numerous therapeutic areas, including cardiovascular, respiratory, infectious, dermatology, oncology, neurological, and rare diseases, and has co-authored more than 70 publications and presentations. Hull has worked in health economics and outcomes research since 2014, and for more than 20 years has held several key clinical research, scientific, and leadership roles in the medical device industry. He earned a Master of Science degree in Biostatistics from the University of Minnesota, and a Bachelor of Science degree in Psychology from the University of Michigan.

Brinda Sriskantha, PhD

Global Portfolio Strategy Lead, Real World Evidence MedTech
IQVIA

As Global Portfolio Strategy Lead for Real World Evidence MedTech, Brinda Sriskantha is responsible for developing cutting-edge real world solutions for MedTech companies around the globe by translating the evolving methodological real world research standards and real world data generation methods into feasible operational delivery strategies to meet the needs of regulators, payers, providers, and patients. A subject matter expert in RWE medical device and digital health studies, she seeks to generate product value by leveraging the most effective, innovative, and compelling strategies within the marketplace from concept to patient. Dr. Sriskantha has previously held positions in Global Business Operations, Project Consulting, and Clinical Research. She obtained a Bachelor of Science in Chemistry and a PhD in Nanotechnology from the University of Kent, UK.

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