Speaker Presentations
Introduction: Welcome and explanation of mock device to be used in the day’s discussion
  • Gayatri Rao, M.D., J.D.—Director, Office of Orphan Products Development (OOPD), Food and Drug Administration (FDA)
  • Linda Ulrich, M.D. — Director, Pediatric Device Consortia Grant Program, OOPD, FDA
Welcome  Pediatric Devices Patient and Family Member Experience 
  • Devin Alvarez — VEPTR Patient and Rixys Alfonso — Devin’s mother
Market Approaches and Considerations Entrepreneurs’ Perspectives 
  • David Ku, M.D., Ph.D. — Professor of Engineering Entrepreneurship, Georgia Tech
  • Nick Deeter — OrthoPediatrics
  • David Melnik — PediaVision
  • Tim Moran – Pediaworks and Pediacath

Perspectives on Pediatric Device Development 

  • Stephen Spielberg, M.D., Ph.D. — Deputy Commissioner for Medical Products and Tobacco, FDA  

Considerations in early stage device development: A Medical device consultant’s perspective

“Show me the Money” — Addressing Funding Issues and Concerns
Moderator:  Eric Chen, M.S.

Overview of potential funding sources

Angel Investor Perspective 
    -Do’s and Don’ts of the pitch
    -How an Angel decides where to invest

Venture Capitalist Perspective 
    -Do’s and Don’ts of the pitch
    -How a VC decides where to invest

Reimbursement strategies

Afternoon Introduction

Clinical Trials Overview and Pediatric Issues

Regulatory Overview
Moderator:  Francesca Joseph, M.D.

IDE/HUD/HDE

510K Pathway

PMA

Lessons Learned by a sponsor-investigator

Marketing Considerations: “I’ve got my clearance or approval—now what?”

Needs-assessment model (IPI)

Closing Remarks
Linda Ulrich, M.D. — FDA

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