Impact Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes

Overview

Are you a digital health innovator? Are you building sensors, wearables, or other digital health tools to be used in clinical trials to capture information about how patients feel, function, or survive?

Join the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the Johns Hopkins University CERSI, and the University of Maryland CERSI for an immersive mini-bootcamp, being held virtually and in a condensed format due to the COVID-19 pandemic.

Be empowered to navigate the Digital Health Technology development and evaluation journey from patient needs assessment, to product development and validation tailored to supporting the context of use, to measuring patient outcomes and preferences.

The hands-on training will provide an opportunity for early-stage innovators to:

• Become fluent with terminology and aware of regulatory considerations and resources.
• Have more informed interactions with regulators.
• Improve their evidence generation.
• Bring safe and effective medical technologies into the healthcare system in a timely manner.

The emphasis of this bootcamp will be on Digital Health Technologies used to facilitate assessment of patient outcomes in clinical trials (i.e., Clinical Outcome Assessments (COAs)).  Instructors are from FDA CDRH.

NOTE: This bootcamp is targeted to beginner and intermediate learners.

Key Words

• Digital Health Technologies (DHTs)
• Clinical Outcome Assessments (COAs)
• Patient-Reported Outcomes (PROs)
• Performance Outcomes (PerfOs)
• Observer-Reported Outcomes (ObsROs)
• Patient Preference Information (PPI)

Learning Objectives

• Develop high-level understanding of the regulation of medical devices and use vocabulary used by FDA when communicating about patient outcome measurements and DHTs.
• Describe important considerations for development, validation, and use of DHTs and outcome measurement tools for regulatory purposes.
• Differentiate between PPI and PROs, and describe how PPI can inform on unmet needs and tool development.
• Develop practical expertise applying bootcamp concepts to cases relevant as an innovator developing and bringing medical technologies to the market.

This event is brought to you by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), the Center of Excellence in Regulatory Science and Innovation (CERSI), and the University of Maryland CERSI.

Contact

For questions and concerns, please email cersi@umd.edu.