Session Organizers: Gwen Fischer, University of Minnesota and Balakrishna Haridas, Texas A&M Engineering
Role of Real World Data for Accelerating Pediatric Labeling of Devices- Impella Example
Angela Lorts, MD, MBA
Director, Ventricular Assist Device Program
Chief Executive Officer of ACTION
Director, Industry Partnerships and Innovation
Professor, University of Cincinnati Department of Pediatrics
Cincinnati Children’s Hospital Medical Center
Cincinnati, OH
Dr. Lorts is a pediatric heart failure cardiologist. Her clinical and research interest are in heart failure and mechanical support. She dedicated her academic career to improving the care and outcomes for heart failure patients by co-founding and directing a collaborative learning network (ACTION). ACTION was founded in 2017 and now includes over 60 institutions in North America as well as many international institutions. ACTION has over 50 leaders focusing on important projects and publishing data to inform on heart failure patient care and treatment. In addition, Dr. Lorts is the physician lead for Industry Partnerships and Innovation at Cincinnati Children's Medical Center and currently working to expediate device development for children.
Sonya Bhavsar, J&J MedTech
Sonya Bhavsar
Sr. Director, Expandable Technologies and Pediatrics Platform
J&J MedTech, Heart Recovery
Rachel Brucker, Medtronic
Rachel Brucker JD, MBA
Sr. Program Manager, Special Requests Program R&D
Cardiac Implantables Technology Development Center
Medtronic
Mike Medina, Novare Medical Consulting
Mike Medina, MS
Regulatory, Clinical & Quality Executive
Novare Medical Consulting
Mike Medina is a seasoned executive with 19 years of experience in the medical device industry, specializing in regulatory, quality and clinical leadership. He has a proven track record of securing innovative product approvals, particularly in the pediatric field. Mike played a pivotal role in achieving best-in-class and first-ever product approvals with the U.S. FDA, leveraging real-world data and the Humanitarian Device Exemption pathway. His expertise led to the approval of the first-in-kind medical device designed to treat pediatric scoliosis, setting a new benchmark in innovation and patient care. Mike continues to advise on pragmatic regulatory and clinical strategies for the purposes of accelerating device development, and population-specific product labeling for underserved patient populations that have historically proven to be difficult to study prospectively.
Session Organizer
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 (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.”
Balakrishna Haridas, PhD
Professor of Practice, Biomedical Engineering
Cain Faculty Fellow
Director, Research - Translational & Industrial Research, Biomedical Engineering
Deputy Executive Director, Principal Investigator and Co-Founder, FDA Southwest Pediatric Devices Innovation Consortium
Affiliated Faculty, Professor, Mechanical Engineering
Texas A&M University College of Engineering
Dr. Haridas is a biomedical engineer, medical device innovator, entrepreneur & educator with ~32 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 Fellow 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-midWest Pediatric Devices Innovation Consortium (SWPDC). His current research focuses on pediatric & fetal surgery, soft tissue repair, and minimally invasive surgery systems and leads the digital health initiatives around Real World Evidence Projects under the SWPDC.