UCSF

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

Note: Times shown above are in Pacific time.

Unfortunately, we have already reached capacity for the 7/28/2020 event. We may be able to release a few seats to small digital health companies so please join the waitlist through the registration link below if you are interested in participating in this session.
We plan to conduct another bootcamp in the future, so please make sure to sign up for our mailing list to be informed for future events.

 

 

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.

 

Registration

The registration fee is $10. Visit https://cersibootcamp.eventbrite.com to register or click the button below.

Click Here to Register

 

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 – 10:15 am

Welcome
Michelle Tarver, MD, PhD - Director, Patient Science and Engagement, FDA
Bakul Patel, MSEE, MBA - Director, Division of Digital Health, FDA

Logistics
Allen Chen, PhD - Program Manager, Patient Science and Engagement, FDA

10:15 – 10:45 am

Recap and Application of Concepts 1: You’ve Got a Digital Health Technology … What Do You Call It?

  • Digital Health Technologies (DHTs)
  • An Introduction to Terminology, Concepts, and Regulation

10:45 – 11:10 am

Recap and Application of Concepts 2: Patient Input and Clinical Outcome Assessments (COAs)

  • Patient Input in the DHT Development Lifecycle
  • DHTs and Clinical Trials: Introduction to Clinical Outcome Assessments (COAs) and their Development & Validation

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

Contact

Please email [email protected] with any questions.