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

Date:

Tuesday, July 28, 2020 - 10:00 am to 2:00 pm

Location:

Online Course - Delivered Virtually by FDA Staff

Brought to you by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and the UCSF-Stanford Center of Excellence in Regulatory Science & Innovation (CERSI).

About

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 and the UCSF-Stanford 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, thus enabling innovators to have more informed interactions with regulators, improve their evidence generation, and 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)).

Key Words

Digital Health Technologies (DHTs), Digital Biomarkers, 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.

Agenda

Bootcamp participants are required to complete approximately 1 hour of pre-bootcamp activities on their own in advance of the live event. The agenda for the July 28, 2020 live virtual bootcamp is below.

Time (Pacific Time)	Topic
10:00 – 10:05 am	Welcome Allen Chen, PhD - Program Manager, Patient Science and Engagement, FDA
10:05 – 10:35 am	Recap and Application of Concepts 1: You’ve Got a Digital Health Technology … What Do You Call It? Bakul Patel, MSEE, MBA - Director, Division of Digital Health, FDA Digital Health Technologies (DHTs) An Introduction to Terminology, Concepts, and Regulation
10:35 – 11:00 am	Recap and Application of Concepts 2: Patient Input and Clinical Outcome Assessments (COAs) Michelle Tarver, MD, PhD - Director, Patient Science and Engagement, FDA Patient Input in the DHT Development Lifecycle DHTs and Clinical Trials: Introduction to Clinical Outcome Assessments (COAs) and their Development & Validation
11:00 - 11:10 am	Q & A
11:10 – 11:45 am	Hands-On Practice 1: Patient Input to Support Your DHT Development
11:45 – 11:50 am	Break
11:50 – 1:00 pm	Hands-On Practice 2: Developing Your DHT to be Used to Support Clinical Investigations If you plan for your product to be used as a COA, how will you define the Context of Use? What evidence will you develop to support your intended use and context of use? Given your product is digital, what other considerations are there when considering use in a clinical investigation?
1:00 – 1:05 pm	Break
1:05 – 1:45 pm	Hands-On Practice 3: Developing Your DHT to be Used Outside of Clinical Investigations (i.e., to Diagnose, Treat, or Promote General Wellness) If you would like to market your product for use outside of a clinical trial, how will you determine whether it is a medical device? How will you determine the regulatory requirements (if any) that apply?
1:45 – 2:00 pm	Concluding Remarks

Instructor Bios

Contact

Please email [email protected] with any questions.