PREVIOUS MEETINGS

• 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

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

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 

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

View and download a detailed version of the agenda here.

Learn more about the event and watch a brief recording here.

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.

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.

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)

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)