3rd Annual Pediatric Surgical Innovation Symposium

Children’s Need Must Drive Market Speed October 23, 2015 | The Knight Conference Center at The Newseum, Washington, DC


“Children have medical device needs that are considerably different from adults. Designing devices for children requires considerations such as growth and development, anatomical and physiological differences, hormonal influences, and activity level. The challenges also include small markets, minimal financial incentives, and regulatory issues. Often, the lack of available devices for children forces clinicians to use an adult device off-label or to improvise. Off-label use may be the only option, but such use can bring risks of serious adverse events that could be avoided if there were more US Food and Drug Administration (FDA)–approved pediatric devices. To address very similar issues related to orphan drugs, the US Congress passed the Orphan Drug Act in 1983 to provide incentives for industry investment in orphan drugs. It was not until 2007 that a somewhat analogous act, the Pediatric Medical Device Safety and Improvement Act, became public law * “
Medtech stakeholders require incentives in forms of legislation and availability of grant programs to develop medical products designed for and tested in children. We hope that friendships that are formed today will lead to partnerships and collaborations to advance innovations in pediatric surgical and medical device development.
*Eskandanian, K., Klein, M., Kim, P., Lessons From Drugs to Devices: A Pediatric Perspective. JAMA Pediatrics. 2015 Sep 8:1-2


Breakfast & Networking


Welcome & Introduction

Kurt Newman, MD | President & CEO, Children's National Health System


Plenary Case 1 Ventricular Assist Devices for Children – The Case of Berlin Heart EXCOR

Chester Koh, MD | Associate Professor of Urology, Pediatrics; Director, Pediatric Robotic Surgery Program; Pediatric Urology Fellowship Program Director, Texas Children's Hospital / Baylor College of Medicine
Timothy Baldwin, PhD, MS | Deputy Branch Chief, Advanced Technology & Surgery, National Heart, Lung, and Blood Institute, National Institutes of Health
Charles D. Fraser, Jr, MD | Surgeon-in-Chief, Texas Children's Hospital
Robert Kroslowitz | President & CEO, Berlin Heart, Inc.
Jackson Radandt | Patient Representative


Break & Networking


Make Your Medical Device Pitch for Kids! Competition 3rd Annual Sheikh Zayed Prize in Pediatric Device Innovation

Bryan Vartabedian, MD, FAAP | Pediatric Gastroenterologist, Baylor College of Medicine and Texas Children’s Hospital; Founder, 33 charts
Charles Berul, MD | Division Chief of Cardiology & Co-Director of the Children's National Heart Institute, Children's National Health System
James Clessuras, JD | Partner, The Law Firm of Wilson Sonsini Goodrich & Rosati
Martha Connolly, PhD | Director, Mtech Baltimore, University of Maryland
Peyvand Khaleghian, MD, PhD | Managing Partner, Avicenna Partners Investment Company LLC
Justin Shaka, MBA | Co-founder & CEO, REBIScan
Tiffany Wilson, MBA | Executive Director, Global Center for Medical Innovation


Lunch Keynote

Anthony Chang, MD, MBA, MPH | Chief Intelligence & Innovation Officer, Children’s Hospital of Orange County


Plenary Case 2
Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices

MODERATOR Tracy Warren | Managing Partner, Astarte Ventures
PANEL Maria Berkman, MD, MBA | Director, Broadview Ventures
Steven Hirschfeld, MD, PhD | Associate Director for Clinical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
Russell Lindemann | Founder & CEO, JustRight Surgical, LLC
Loudon Owen, JD, MBA | Managing Partner, McLean Watson Capital Inc.
Ken Schaner, JD | General Counsel, Cystic Fibrosis Foundation
Eric Stone, EdM, MBA | Co-founder & CEO, Velano Vascular, Inc.


Plenary Case 3
Off-Label & Investigational Use of Marketed Medical Devices in Pediatric Population

Matthew Oetgen, MD | Division Chief, Orthopaedic Surgery and Sports Medicine, Children's National Health System
Michael Harrison, MD | Professor of Surgery, Pediatrics, OB-GYN, and Reproductive Sciences, Emeritus, University of California San Francisco; UCSF Pediatric Device Consortium
Robin Meier | Patient Representative
B. Stephens Richards, MD | Chief Medical Officer, Texas Scottish Rite Hospital
Mark Throdahl | President & CEO, OrthoPediatrics Corp
Warren Vanhout | Manager, Field Clinical Research, Medtronic


Plenary Case 4
Pediatric Device Benefit-Risk Assessment: Voice of the Patient

Kara Haas, MD, MPH, FACS | Director, Global Strategic Regulatory Affairs, Johnson & Johnson
PANEL Amy Basken | Patient Representative
Maureen Japha, JD | Associate Director, Regulatory Policy and Legal Counsel, Faster Cures
Michelle McMurray-Heath, MD, PhD | Worldwide Vice President, Medical Devices, Johnson & Johnson
Michael C. Morton | Vice President, Corporate Regulatory Affairs, Medtronic
Andrew Pedtke, MD | Co-founder & CEO, LIM Innovations
Vasum Peiris, MD, MPH | Chief Medical Officer, Pediatrics & Special Populations, Center for Devices & Radiological Health, Food & Drug Administration
Erik D. Skarsgard, MD, MSc, FACS, FAAP, FRCSC | Professor, Pediatric General Surgeon, Chief of Surgery, BC Children’s Hospital Chair of APSA Innovation Committee


Closing Keynote

Robert M. Califf, MD, MACC
Deputy Commissioner for Medical Products and Tobacco, Food and Drug Administration MODERATOR Marshall Summar, MD | Division Chief, Genetics and Metabolism, Children's National Health System


Award Ceremony & Cocktail Reception



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