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


  • Maurice Jones, JD, MA CEO, OneTen

  • Patti White, MBACEO, Hemex Health

  • Vasum Peiris, MD, MPH, FAAP, FACC, FASEChief Medical Officer and Director – Pediatrics and Special Populations, CDRH, FDA

  • Kate Garrett, BSManaging Partner, Sonder Capital

  • Hanna Song, PhDChief 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


  • 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


  • 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 USMartijn Cox, PhD (Chief Technology Officer, Xeltis)

  • Materials regulation for pediatric heart valvesScott McNamee, PhD (Materials Engineer, Office of Product Evaluation and Quality, CDRH, FDA)


  • 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)