Promoting Collaboration to Improve Pediatric Care.
The Pediatric Device Innovators Forum is a recurring collaborative educational experience hosted by the FDA-supported pediatric device consortia and designed to connect and foster synergy among innovators across the technology development ecosystem interested in pediatric medical device development.
A COLLABORATION BETWEEN THE FDA & THE 5 PEDIATRIC DEVICE CONSORTIA
UPCOMING FORUM | 10.07.22
Each forum will focus on a different topic relevant to pediatric medical device innovators. Our upcoming forum is shown below; keep checking back with us for future forum topics!
Role of the Unique Device Identifier (UDI) in Improving Pediatric Health Equity
Hosted by the UCSF-Stanford Pediatric Device Consortium
Friday, October 7th, 2022 | 11:30pm - 1:00pm PT (2:30pm - 4:00pm ET)
Learning Goals:
Introduce the role and value of the unique device identifier (UDI) in facilitating pediatric device innovation and real-world evidence studies.
Discuss the challenges with UDI implementation and identify strategies to increase support for adoption at children’s hospitals nationwide.
Agenda:
11:30-11:32 am Welcome
Michael Harrison, MD; PI & Director, UCSF-Stanford PDC
11:32-11:35 am Introduction: Overview & Goals for PDIF #8
Stefano Rensi, PhD & Elizabeth Gress, MPA; RWE Leads, UCSF-Stanford PDC
11:35-11:45 am Keynote: Impact of UDI in Bolstering Health Equity for Pediatric Patients
Florence Bourgeois, MD, MPH; Harvard Pediatrics & Computational Health
11:45am-12:15 pm Panel 1: Perspectives from Supply Chain, Value Committees, and Academic Research
Moderator: James Wall, MD, Stanford Director, UCSF-Stanford PDC
Panelists:
Florence Bourgeois, MD, MPH; Harvard Pediatrics & Computational Health
Kunj Radu Sheth, MD; Stanford Pediatric Urology / Value Committee
Erika Torjusen, MD; FDA Office of Orphan Products Development
12:15-12:45 pm Panel 2: Challenges and Opportunities for UDI Uptake
Moderator: Stefano Rensi, PhD; RWE Lead, UCSF-Stanford PDC
Panelists:
Indira Konduri, UDI Lead @FDA CDRH
Juan Espinoza, MD; CHLA & CTIP
Natalia Wilson, MD, MPH; ASU & NESTcc UDI Investigator
Vasum Peiris, MD; FDA Center for Devices and Radiological Health
12:45-12:59 pm Audience Q&A / Discussion
Moderator: Janene Fuerch, MD; Stanford Assistant Director, UCSF-Stanford PDC
12:59-1:00 pm Announcement of PDIF #9