PREVIOUS MEETINGS
PDIF #10: Overcoming Commercialization Barriers in Peds MedTech through Partnerships
Hosted by National Capital Consortium for Pediatric Device Innovation (NCCPDI), Southwest National Pediatric Device Innovation Consortium (SWPDC) and The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP)
Thursday, August 3rd, 2023 | 11:00am - 12:30pm PT (2:00pm - 3:30pm ET)
The National Capital Consortium for Pediatric Device Innovation (NCCPDI), Southwest National Pediatric Device Innovation Consortium (SWPDC) and The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) are hosting this installment of the FDA-supported Pediatric Device Innovators Forum (PDIF). This PDIF will feature a panel discussion on Overcoming Commercialization Barriers in Peds MedTech through Partnerships. Panels will include PDC supported founders and the partners they have collaborated with to advance the commercialization of their pediatric medtech devices.
Agenda:
Part 1: Learn - moderated by Kolaleh Eskandanian, Ph.D, MBA, PMP, Director, NCCPDI (30 minutes)
A conversation with Christopher Almond focused on financial barriers and opportunities for pediatric medical device development and commercialization.
Speaker:
Christopher Almond — Professor of Pediatrics (Cardiology), Stanford Medicine Children's Health
Part 2: Discuss - moderated by Juan Espinoza, MD, Director, CTIP (30 minutes)
This discussion will explore the experiences of pediatric medical device innovators with supply chain and commercialization partnerships that have supported bringing their devices to market, including the barriers and faciliators they identified on their journey.
Panelists:
Peggy Kaufman — Vice President, Contracting Operations & Center of Excellence, Vizient
Daniel Clark — Founder and CEO, Linear Health Sciences
Eric Stone — Co-Founder and CEO, Velano Vascular
Maureen L. Mulvihill — President, Co-Founder, and CEO, Actuated Medical, Inc.
Part 3: Engage - moderated by Chester Koh, MD, Director, SWPDC (30 minutes)
A question and answer session with all speakers. We will also address questions from attendees submittted prior to and during the event.
PDIF #9: Patient-Matched Medical Devices for Pediatric Patients:
A Case Study
Hosted by Pennsylvania Pediatric Medical Device Consortium (PPDC)
Tuesday, March 7th, 2023 | 12:00pm - 1:30pm PT (3:00pm - 4:30pm ET)
The Pennsylvania Pediatric Medical Device Consortium (PPDC) is hosting this installment of the FDA-supported Pediatric Device Innovators Forum (PDIF). This forum is being held in conjunction with the McGowan Institute for Regenerative Medicine’s 2023 Scientific Retreat. The PDIF will feature a panel discussion on Patient-Matched Medical Devices for Pediatric Patients, including a case study on the collaboration between Children’s Hospital of Philadelphia and Actuated Medical to develop patient-matched, non-invasive pediatric respiratory masks and nasal prongs.
Panelists include:
Natalie Napolitano, MPH, RRT-NPS, FAARC - Moderator
Research Clinical Specialist
Respiratory Therapy Department
Children’s Hospital of Philadelphia
Elizabeth Silvestro, MSE
Additive Manufacturing Engineering Manager
Children’s Hospital Additive Manufacturing for Pediatrics (CHAMP) 3D Labs
Children’s Hospital of Philadelphia
Roger Bagwell, PhD
Director of Research and Development
Actuated Medical, Inc.
Jonathan M. Morris, MD
Radiologist
Head of the 3D Anatomic Modeling Laboratory
Mayo Clinic
Prashant N. Kumta, PhD
Edward R. Weidlein Endowed Chair Professor
Swanson School of Engineering and School of Dental Medicine
Department of Bioengineering, Chemical and Petroleum Engineering. Mechanical Engineering and Materials Science
Department of Oral Biology
University of Pittsburgh
Matthew Di Prima, PhD
Materials Scientist
Division of Applied Mechanics (DAM)
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)
U.S. Food & Drug Administration
PDIF #8: Role of the Unique Device Identifier (UDI) in Improving Pediatric Health Equity
Hosted by 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
PDIF #7: Pediatric Medical Device Development, Disability Justice, and the Patient Voice
Hosted by The West Coast Consortium for Technology & Innovation in Pediatrics
Tuesday, May 24th, 2022 | 12:30pm - 2:00pm PT (3:30pm - 5:00pm ET)
Speakers:
Rob Stone — Patient Advocate, Little Lobbyists
Bonnie Swenor, PhD, MPH — Director, Johns Hopkins Disability Health Research Center
Rob Wudlick — Engineering Consultant, Abilitech Medical
Angie Conley — CEO, Abilitech Medical
Michelle Tarver, MD, PhD — Deputy Director, Office of Strategic Partnerships and Technology Innovation — Program Director for Patient Science, Digital Health Center of Excellence
Ryan Easterly — Executive Director, WITH Foundation
Theresa Hayes Cruz , PhD — Director, NICHD National Center for Medical Rehabilitation Research (NCMRR)
Agenda:
Introductory Remarks — Juan Espinoza, MD
Patient Perspective — Rob Stone
Research Perspective — Bonnie Swenor, PhD, MPH
Industry Perspective — Angie Conley, Rob Wudlick
Regulatory Perspective — Michelle Tarver, MD, PhD
Moderated Panel Discussion
Q & A
Closing Remarks and date of the next Forum
PDIF #6: Pediatric Device Trial Infrastructure: Clinical investigation of an implantable pediatric ventricular assist device - NHLBI PumpKIN (Pumps for Kids Infants and Neonates) Trial
Hosted by the Pennsylvania Pediatric Medical Device Consortium
In conjunction with the McGowan Institute for Regenerative Medicine Scientific Retreat 2022
Tuesday, March 8th, 2022 | 3:00pm - 4:30pm ET (12:00pm - 1:30pm PT)
Speakers & Panelists:
Harvey Borovetz, PhD (chair) – PumpKIN Site Principal Investigator
Distinguished Professor, Department of Bioengineering, University of Pittsburgh
Ashley Magnavita, MPH, PMP – PumpKIN contact of record, Clinical Trial Monitoring & Protocol Design
Director, Clinical Research Project Management, HealthCore
Kurt Dasse, PhD – Member, NIH Executive Committee for the PumpKIN Program
President, VADovations, Inc.
Tim Baldwin, PhD – Former Deputy Chief of Advanced Technologies & Surgery Branch, NHLBI Division of Cardiovascular Sciences, Program Officer for PumpKIN
Senior Staff Fellow/Reviewer, Circulatory Support Devices Team, FDA
Richard Schaub, PhD – PumpKIN Site Support Center Preparedness & Bioengineering Pump Management
Adjunct Assistant Professor of Bioengineering, University of Pittsburgh
Sr. Director of Artificial Heart Program, UPMC
Sr. Director of Mechanical Circulatory Support, Procirca
PDIF #5: Pediatric Surgical Device Development: Challenges and Future Directions
Hosted by The Southwest National Pediatric Device Innovation Consortium
Thursday, December 2nd, 2021 | 1:00pm - 2:30pm CT (2:00pm - 3:30pm ET)
PDIF #4: Using Real-World Evidence to Accelerate Pediatric Device Development: Challenges and Future Directions
Hosted by The UCSF-Stanford Pediatric Device Consortium
Thursday, September 23rd, 2021 | 11:00am - 12:30pm PT (2:00pm - 3:30pm ET)
Speakers & Panelists:
Felipe Aguel, PhD -- Deputy Director, Office of Clinical Evidence & Analysis, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Sanket Dhruva, MD -- Assistant Professor of Medicine, UC San Francisco and San Francisco Veterans Affairs Medical Center
Brandon Dottin-Haley -- Chief Business Development Officer, Sonavi Labs
Christian Howell -- Vice President and General Manager, Medical Devices & Diagnostics Group, Aetion
Anitha John, MD -- Medical Director of the Washington Adult Congenital Heart Program, Children’s National Hospital
Jonathan McElwee -- Senior Manager of Regulatory Affairs, AtriCure
Vasum Peiris, MD -- Chief Medical Officer and Director for Pediatrics and Special Populations, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Erika Torjusen, MD -- Director of the Rare Pediatric Disease, Humanitarian Use Device, and Pediatric Device Consortia Grant programs, Office of Orphan Products Development, U.S. Food and Drug Administration
Nancy Yu -- CEO, AllStripes
Agenda:
Welcome and Introductory Remarks - Hanmin Lee, MD, Stefano Rensi, PhD & Elizabeth Gress, MPA (11:00am PT / 2pm ET)
FDA Perspective: Overview of RWE @ FDA - Felipe Aguel, PhD (11:08am PT / 2:08pm ET)
RWE in the Startup World: 3 Snapshots - Moderator: James Wall, MD (11:17am PT / 2:17pm ET)
Panel Discussion - Moderator: Stefano Rensi, PhD (11:48am PT / 2:48pm ET)
Audience Q&A - Moderator: Janene Fuerch, MD (12:13pm PT / 3:13pm ET)
Closing Remarks and PDIF #5 Announcement - Chester Koh, MD (12:28pm PT / 3:28pm ET)
View and download a detailed version of the agenda here.
Learn more about the event and speakers by viewing the event brochure.
PDIF #3: Focused Ultrasound for Pediatric Indications
Hosted by The National Capital Consortium for Pediatric Device Innovation
Thursday, July 22nd, 2021 | 2:00pm - 3:30pm ET
Hosted by The National Capital Consortium for Pediatric Device Innovation
Thursday, July 22nd, 2021 | 2:00pm - 3:30pm ET
Speakers:
Jessica Foley, PhD — Chief Scientific Officer, FUS Foundation
Michael Anderson, MBA, FAAP, FCCM, FAARC — Senior Advisor, Children's National Hospital and US Department of Health and Human Services
Roger Packer, MD — Senior Vice President of the Center for Neuroscience and Behavioral Medicine, Children’s National Hospital
Arjun Desai, MD — Chief Strategic Officer, Insighttec
Karun Sharma, MD — Director, Interventional Radiology, Children's National Hospital
Arun Menewat, MD — Chairman and CEO, Profound Medical
Francesca Joseph, MD — Co-investigator, National Capital Consortium for Pediatric Device Innovation, Children’s National Hospital
Gordon Schatz, JD — President, Schatz Reimbursement Strategies, LLC
Mary Daymont, MSN — Vice President of Revenue Cycle and Care Management, Children’s National Hospital
Agenda:
Welcome and Introductory Remarks (2:00pm - 2:05pm)
Keynote Fireside Chat - Jessica Foley and Michael Anderson (2:05pm - 2:15pm)
Case study #1: Osteoid Osteoma (panel discussion and Q&A) (2:15pm - 2:50pm)
Case Study #2: DIPG (panel discussion and Q&A) (2:50pm - 3:25pm)
Closing Remarks and date of the next Forum (3:25pm-3:30pm)
Learn more about the topic and speakers here.
PDIF #2: Health Equity Challenges in Pediatric Medical Device Development
Hosted by The West Coast Consortium for Technology & Innovation in Pediatrics
Thursday, May 20th, 2021 | 3:00pm - 4:30pm ET
Speakers:
Maurice Jones, JD, MA — CEO, OneTen
Patti White, MBA — CEO, Hemex Health
Vasum Peiris, MD, MPH, FAAP, FACC, FASE — Chief Medical Officer and Director – Pediatrics and Special Populations, CDRH, FDA
Kate Garrett, BS — Managing Partner, Sonder Capital
Hanna Song, PhD — Chief Diversity Officer, Children's Hospital Los Angeles
Gordon Schatz, JD — President, Schatz Reimbursement Strategies, LLC
Charisee Lamar, PhD, MPH - Director, Office of Health Equity, NICHD
Agenda:
Introductory Remarks — Juan Espinoza, MD (3:00pm-3:05pm)
Framing Health Equity - Maurice Jones, JD, MA (3:05pm-3:15pm)
Case Study: The Gazelle Sickle Cell Disease Diagnostic Device — Patti White, MBA (3:15pm-3:25pm)
Moderated Panel Discussion (3:25pm-4:00pm)
Audience questions addressed to the panelists (4:00pm—4:25pm)
Closing Remarks and date of the next Forum (4:25pm-4:30pm)
PDIF #1: Biomaterial Challenges in Pediatric Prosthetic Heart Valves Development
Hosted by the Pennsylvania Pediatric Medical Device Consortium
Thursday, March 11th, 2021 | 3:00pm - 4:30pm EST
Speakers:
Pediatric heart valve prostheses: Addressing unmet needs — Jonathan Chen, MD (Chief, Cardiothoracic Surgery, CHOP)
New synthetic biomaterials for pediatric heart valves — William Wagner, PhD (Director, McGowan Institute, Univ. of Pittsburgh)
Preclinical development of a novel heart valve prosthesis for pediatrics — Narendra Vyavahare, PhD (Professor, Dept. of Bioengineering, Clemson University)
Pediatric prosthetic heart valve trials in the US — Martijn Cox, PhD (Chief Technology Officer, Xeltis)
Materials regulation for pediatric heart valves — Scott McNamee, PhD (Materials Engineer, Office of Product Evaluation and Quality, CDRH, FDA)
Agenda:
Introductory Remarks—Vasum Peiris, MD, CDRH, FDA (3pm-3:05pm)
Panelists Introductory Remarks (3:05pm-3:20pm)
Questions (pre-submitted) addressed to the panelists (3:20pm-4:00pm)
Audience questions addressed to the panelists (4:00pm—4:25pm)
Final remarks, Post Forum activities, and topic and date of the next Forum (4:25-4:30pm)