PDIC Breakthrough & Networking

PDIC Overview

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

SWPDC Overview

• Chester Koh, MD
  Baylor College of Medicine and Texas Children’s Hospital
• Balakrishna Haridas, PhD
  Texas A&M University College of Engineering
   

TAP Advisor
Center for Devices and Radiological Health
U.S. Food & Drug Administration

Moderator: Chester Koh

Panelists:

• Cory Criss, Midwest Pediatric Device Consortium
• Kolaleh Eskandanian, KPI
• Juan Espinoza, Consortium for Technology & Innovation in Pediatrics
• Julia Finkel, Alliance National Pediatric Device Consortium
• Kunj Sheth, Stanford Biodesign Impact
• Leanne West, Georgia Institute of Technology

Moderator: Bala Haridas

Panelists:

• Alisa Niksch, Owlet Care
• Kolaleh Eskandanian SPARK for Innovations in Pediatrics, BARDA Hub
• Annamarie Saarinen, Bloom Standard
• Dori Jones, AcQumen Medical

Founder and Principal
KPI

Dr. Eskandanian is a health care innovation and strategy executive with more than 20 years of experience building, funding and scaling national platforms across pediatric health, biotech, medtech and digital health. She has a background in mechanical engineering, industrial economics and business administration. Her work focuses on regulated medical product development and commercialization, translating promising technologies into products that reach patients. She has served as principal investigator on more than $35 million in competitive federal funding and has led portfolios advancing regulated medical products from early development through regulatory authorization and market adoption, with deep expertise in structuring and leading public-private partnerships. Dr. Eskandanian is the former vice president and chief innovation officer at Children’s National Hospital, where she built enterprise innovation infrastructure and led the FDA-funded Pediatric Device Consortium, the National Capital Consortium for Pediatric Device Innovation and the Alliance for Pediatric Device Innovation. She is the inaugural principal investigator of the Biomedical Advanced Research and Development Authority-funded SPARK Accelerator Hub, the nation’s only accelerator dedicated to pediatric countermeasures, and continues to serve as its program director. She serves on the boards of life sciences startups, is an angel investor with Citrine Angels, and a venture fellow with Alumni Ventures. In 2025, she founded KPI, a healthtech advisory firm serving startups, health systems and investors across the total product life cycle, including strategy, evidence generation, regulatory alignment, reimbursement planning and commercialization.

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.”

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

Co-Founder & CEO
AcQumen Medical

Bio: Dori Jones is the Co-Founder and CEO of AcQumen Medical, a startup developing and commercializing UltraTrac - the first ultrasound-guided impedance technology for rapid and accurate assessment of blood flow in critically ill infants and children.  Dori has been supporting cardiac and critical care devices in various roles for 19 years; she has degrees in Mechanical and Biomedical Engineering and a background in R&D, clinical education and marketing. She's been responsible for both pre-commercial research and post-commercial adoption for medical device companies ranging from startups to Abbott and Medtronic.  Her passion for pediatric innovation was sparked by her own experience as the mom of a NICU and pediatric ICU patient.

His clinical area of expertise is in minimally invasive surgery in children for pediatric urologic conditions, and especially with robotic surgery and the pediatric device needs in this area.  He served as the founder of the Pediatric Robotic Surgery Program at BCM / Texas Children’s Hospital and Baylor College of Medicine as well as USC / Children’s Hospital Los Angeles. He also serves as the Managing Director and Pediatric Program Director of the North American Robotic Urologic Society’s annual meeting (NARUS.US).

He is also the founder and executive director of the Southwest-Midwest National Pediatric Device Innovation Consortium (SWPDC.org) which is one of five FDA P50 grant-supported multi-institutional consortia that is dedicated to improving children’s health by supporting pediatric device innovators in creating novel pediatric medical devices with local, regional, and national institutional and innovation partners.  He also has been a NIH / NIDDK-funded principal investigator for research in bladder tissue engineering / regeneration / inflammation and other non-cancer urologic conditions. 

CEO, Research PI
Bloom Standard

Bio: Annamarie is a public health economist, Humphrey Policy Fellow, and mother of a baby diagnosed with critical heart defects. She is the co-founder and CEO of the Newborn Foundation and Bloom Standard, an ultrasound data intelligence platform for maternal, newborn and child health applications. Annamarie has helped develop and launch 4 separate medical devices into the field - and has been recognized for spearheading the U.S. effort to become the first nation to implement universal newborn screening for heart defects (CCHD) - the most common and deadly birth defect. To date, 70 million newborns have been screened as part of implementation in all 50 states and millions more in two dozen countries internationally. Annamarie was appointed by the U.S. Secretary of Health and Human Services to the federal Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) and serves on the Minnesota Department of Health's Newborn Advisory Committee. She has been a co-PI on 12 multi-center clinical research projects and co-author on 18 published manuscripts tied to diagnostics, screening and device development for pediatric patients. Under her leadership, development for Bloom Standard’s RAPIDscan technology has been supported by the Gates Foundation, the Mayo Clinic Platform_Accelerate program, and the FDA-funded Pediatric Device Consortia (PDC), including Children’s National Medical Center, the Alliance for Pediatric Device Innovation, UCSF-Stanford Pediatric Device Consortium, University of Minnesota PDIC, Stanford Biodesign / Impact 1, Southwest National Pediatric Device Innovation Consortium, Texas Medical Center Innovation, Swansea University School of Medicine, Health and Life Science, the Welsh Government, and more than a dozen academic and clinical partner sites globally.

Consulting Co-Director
Stanford Biodesign Impact

Kunj Sheth is a pediatric urologist and consulting co-director of Stanford Impact1 and UCSF-Stanford PDC, which aims to improve the health, safety, and quality of life of pediatric patients and pregnant women. Through her experiences in early stage urology startups, she has firsthand experience navigating different funding landscapes with variable market sizes, including a fetal HDE device with high-life saving impact potential. She has also served as co-chair of a large tertiary care hospital value committee.

Chief Engineer Pediatric Technologies, Georgia Institute of Technology
Chief Research and Innovation Officer, Shriners Children’s
President, International Children’s Advisory Network

Leanne West is deeply embedded in the pediatric healthcare innovation ecosystem locally and globally, bringing together partners to accelerate solutions for children. She is a Regents Researcher and Chief Engineer of Pediatric Technologies at the Georgia Institute of Technology, where she also directs the Pediatric Innovation Network. She shares her time with Shriners Children’s as their Chief Research and Innovation Officer. West also is the President of the International Children’s Advisory Network (iCAN), a nonprofit elevating pediatric patient voices in healthcare, research, and innovation.

West serves on the MDIC NESTcc executive committee, the MDIC Health Economics and Patient Value committee, the Board of Georgia Technology Authority (GTA), the Technology Association of Georgia (TAG) Digital Health Board, the Georgia Health Information Network (GaHIN) Board, the executive team of the International Society for Pediatric Innovation (iSPI), and the Board of Patient Focused Medicines Development (PFMD). She is also on the Steering Committee for the Pediatric Trials Network (PTN).