Cutting Edge Pediatrics

Nick Von Bergen
Professor of Pediatric Cardiac Electrophysiology, The University of Wisconsin - Madison

Abstract: Dr. Von Bergen and Atrility Medical, in collaboration with the University of Wisconsin invented, developed, manufactured and now sells the AtriAmp, a device specifically designed to address the clinical needs of pediatric patients.  Dr. Von Bergen will use experience to discuss some of the challenges and resources available for those interested in pediatric device innovation.

Bio: Dr. Nick Von Bergen is a full time pediatric cardiac electrophysiologist at the University of Wisconsin - Madison.  He is also the inventor of the AtriAmp, a device designed to improve rhythm diagnosis for post-operative cardiac patients, and the co-founder of Atrility Medical.  His clinical, academic and commercial interests are all centered on improving pediatric cardiac care.

Pranava Sinha, MD, MBA
Division Chief of Pediatric Cardiac Surgery
University of Minnesota Medical School

Pranava Sinha, MD, has been appointed as the new Division Chief and Professor of Pediatric Cardiac Surgery in the Department of Surgery at the University of Minnesota Medical School and the M Health Fairview Masonic Children's Hospital. Dr. Sinha will serve a critical role in building and co-leading an interdisciplinary team to provide exemplary patient care and family experience. He will be Co-director of the Heart Center at the M Health Fairview Masonic Children's Hospital and the inaugural holder of the John Bass Chair in Pediatric Cardiovascular Health.

Balakrishna Haridas
Professor-of-Practice, Director Translational Research, Biomedical Engineering,Texas A&M University

Abstract: Percutaneous fetoscopic surgery, while significantly less invasive than open in utero surgery, carries a very high risk of chorioamniotic membrane separation and preterm prelabor rupture of membranes (PPROM).  In this presentation, Dr. Haridas will discuss the development of the ChorioAnchor, a percutaneously delivered novel resorbable anchoring system for fixation of the chorioamniotic membranes during fetoscopic surgery.  He will also discuss how the FDA funded P50 pediatric consortium program, multiple SBIR grants, and a regional innovation ecosystem were leveraged to invent, develop, manufacture, test, and move this device along the regulatory pathway.

Bio: Dr. Haridas is a biomedical engineer, medical device researcher, entrepreneur & educator with ~30 years of industrial and academic experience in translational research, development, and commercialization of FDA Class II and III medical devices for minimally invasive & endovascular interventions, soft tissue repair, drug delivery systems, and AI/ML platforms for medical devices. He has raised over $100 million in funding, led/participated in multiple med tech ventures and driven ~18 products through 510k/PMA FDA and CE regulatory clearances & approvals.   Over the course of his career, Dr Haridas has served in various senior leadership roles spanning translational research, entrepreneurship, and commercialization in large corporations, startup companies, and academic positions at the University of Cincinnati, and Texas A&M University. In recognition for his contributions over the years, he was inducted as a Fellow of the American Institute of Medical &
 Biological Engineering (AIMBE), and as a Senior Member of the National Academy of Inventors (NAI). 

Dr. Haridas is currently a Professor of Practice & Director of Translational & Industrial Research in the department of Biomedical Engineering at Texas A&M, and the Deputy Executive Director & Co-Founder of the FDA P50 Southwest national Pediatric Devices Innovation Consortium (SWPDC).  His current research focuses on pediatric & fetal surgery, soft tissue repair, and minimally invasive surgery systems and is the inventor of the ChorioAnchor technology featured in this presentation.

Jonathan Strutt
Pediatric Emergency Medicine, University of Minnesota

Abstract: I will discuss the design process including obstacles and multiple iterations of what ultimately became a tool to confirm nasogastric tube placement.

Bio: Jonathan Strutt, MD is an Assistant Professor in Pediatric Emergency Medicine at the University of Minnesota Medical School.  His primary research focus is in innovation and technology where he holds five medical device patents including nasogastric tube placement confirmation, a smartphone application measuring capillary refill time, and a neonatal pneumothorax decompression device.  He advises biomedical and mechanical engineering undergraduate students in their senior design course and mentors post-graduate students in medical device development.

Gwen Fischer
Associate Chair of Research, Associate Professor, Department of Pediatrics

Dr. Fischer is an Associate Director of the Earl E. Bakken Medical Devices Center, Associate Chair of Research, Associate Professor, Department of Pediatrics, Faculty Member, Division of Pediatric Critical Care Medicine, Pediatric ECMO Co-Director, UofMN Medical School. Dr. Fischer is a Pediatric Critical Care Physician with a passion for development and testing of innovative medical products and pharmaceuticals. Her expertise is in critical care from preemies to adults, and devices for adults and pediatric patients with an emphasis in congenital heart disease, ECMO, and cardiopulmonary devices. Dr. Fischer founded and directs an industry-academic consortium to accelerate pediatric medical devices (www.thepdic.org). Dr. Fischer has significant experience in developing medical devices and has successfully worked with numerous medical device companies in product development, including clinical studies, and commercialization. Dr. Fischer has con
 sulted with the FDA Pediatric Advisory Committee and reviewed post-market SAE for drugs and devices. Dr. Fischer is a sought-after speaker with a portfolio of publications on medical device, critical care, ECMO, drugs and innovation. Dr. Fischer has received numerous awards including ‘Minnesota’s Top Doctor.”