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 Program
Center for Devices and Radiological Health
US Food & Drug Administration

"FDA TAP Program for Breakthrough Medical Devices"
Overview and updates on FDA’s Total Product Life Cycle Advisory Program for breakthrough medical devices

Bio: Kai Kadoich’s 16-year career in MedTech has spanned a variety of consulting, industry, and government roles. At L.E.K. Consulting, Kai advised MedTech and pharma companies on market entry, competitive strategy, and portfolio decisionmaking. At Medtronic, Kai worked in the Japan region and in the Cardiovascular and Neuromodulation businesses, where he held leadership roles in marketing, strategy, business development, and business management. Kai has experience with all stages of the MedTech product lifecycle including M&A/investing, portfolio planning, product development, product launch, commercialization, and market development. Kai joined the FDA as a TAP Advisor in 2023 and is based in the Twin Cities.

Moderator: Chester Koh

Panelists:

• Cory Criss, Midwest Pediatric Device Consortium
• Kolaleh Eskandanian, KPI
• Juan Espinoza, The Consortium for Technology & Innovation in Pediatrics
• Julia Finkel, Alliance National Pediatric Device Consortium
• Kunj Sheth, Stanford Biodesign Impact
• Leanne West, Shriners Children’s

Moderator: Bala Haridas

Panelists:

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

Assistant Professor, Division of Pediatric Surgery
Director, Innovation Center at Nationwide Children’s Hospital
Principal Investigator, Midwest Pediatric Device Consortium 
Program Director, Surgical Critical Care Fellowship 
Co-director, Extracorporeal membrane oxygenation (ECMO) 

Bio: Dr. Criss is a pediatric surgeon at Nationwide Children’s Hospital (NCH), program director of surgical critical care, and co-director of the extracorporeal membrane oxygenation (ECMO). His clinical work is focused on esophageal and thoracic disease, ECMO, critical care, and pilonidal disease. In addition, Dr. Criss is the founder and director of the Innovation Center at Nationwide Children’s Hospital, an internal hospital accelerator with a full-time biomedical engineering, entrepreneur, and advisor team focused on driving innovative projects forward, identifying new ideas, and device development. He is the principal investigator and COO of the ~6.95 million dollar FDA funded Midwest Pediatric Device Consortium (MPDC) a multi-institutional consortium focused on pediatric device development for inventors across the country. In addition, he also services on the Technology Innovation Prioritization Committee, the Steering Committee of the Product & Equipment Value Analysis (PEVA) team, Clinical Pathways Program, and Center for Surgical Outcomes Research. 

Founder and Principal
KPI

Biomedical Advanced Research and Development Authority
SPARK for Innovations in Pediatrics, BARDA Hub

Bio: 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.

Chief Research Informatics Officer
Lurie Children's

Principal Investigator and Executive Director
The Consortium for Technology & Innovation in Pediatrics

Bio: Juan Espinoza, MD, is the Principal Investigator and Executive Director of CTIP (The Consortium for Technology & Innovation in Pediatrics), a pediatric medical device accelerator funded by the FDA. A board-certified pediatrician and informaticist, Dr. Espinoza has led CTIP since 2018, expanding the program’s national footprint and deepening its support for pediatric innovation.

Dr. Espinoza’s research spans medical device development, health informatics, regulatory science, and health outcomes. He has held leadership roles in clinical informatics and digital health across several institutions, and currently serves as the Chief Research Informatics Officer at Lurie Children’s Hospital and Associate Director of the Center for Biomedical Informatics and Data Science at Northwestern University. He continues to see patients as a hospital-based pediatrician and is committed to leveraging technology and data to improve health outcomes for children, especially those in underserved communities.

Pediatric Anesthesiologist & Director of Pain Medicine Research and Development
The Sheikh Zayed Institute for Pediatric Surgical Innovation
Children’s National Hospital

Professor of Anesthesiology, Pediatrics and Critical Care Medicine
George Washington University School of Medicine

Bio: Julia Finkel, MD is a pediatric anesthesiologist and Director of Pain Medicine Research and Development for The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and Professor of Anesthesiology, Pediatrics and Critical Care Medicine, at the George Washington University School of Medicine. She has extensive experience both designing and conducting multi-center pediatric analgesic clinical trials and developing pharmacodynamic assessment tools and methodologies both in the laboratory and for pediatric clinical applications. In 2015, she founded AlgometRx, Inc. to commercialize a platform technology developed to objectively measure pain and drug effect that leverages the discovery of a novel physiological biomarker. She co-leads two accelerators at Children’s national; the FDA PDC Alliance for Pediatric Innovation (APDI) and the BARDA accelerator hub, SPARK for Innovations in Pediatrics.

Associate Chair of Research, Associate Professor, Department of Pediatrics

Bio: 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. 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 consulted 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.

Professor of Urology, Pediatrics and OB/GYN, Baylor College of Medicine and Texas Children's Research Institute

Executive Director, SWPDC

Bio: Dr. Chester Koh is a  pediatric urologist and tenured Professor of Urology, Pediatrics, and OB/GYN at Baylor College of Medicine (BCM), an Advisory Council Member at the Texas Children’s Research Institute and a “physicianeer” with 30 years of experience in both medicine and engineering.  Dr. Koh received his B.S. with Honors in Mechanical Engineering from UC Berkeley, his MD from Tufts University School of Medicine, and his MBA from the University of Illinois Urbana Champaign. He also completed his urology residency at USC and his pediatric urology fellowship at Boston Children’s Hospital / Harvard Medical School.

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. 

Senior Director of Medical Affairs
Owlet Baby Care, Inc.

Bio: Dr. Alisa Niksch is a pediatric cardiologist and electrophysiologist and currently serves as Senior Director of Medical Affairs at Owlet Baby Care, Inc., providing leadership for the clinical trial strategy, regulatory processes, and commercialization of the company’s medical device products, including a leadership role in gaining the company’s first 510(k) and de novo FDA clearances. She has lent her experience to the digital health, medical device, and remote patient monitoring fields since starting her practice at Tufts Medical Center in 2010. Dr. Niksch was Chief Medical Officer of Genetesis, Inc., a company which created a novel cloud-connected and AI-powered cardiac diagnostics and imaging platform, where she led pivotal clinical trials and managed medical affairs initiatives. She has been an advisor, researcher, and thought leader for multiple healthcare companies like AliveCor, Cohere Health, Ometri, PraxSim VR, Medaica, Mindchild Medical, Zephyr Technologies, and Sproutling. She continues to be a startup mentor with programs at Northeastern University and MassChallenge HealthTech. She has authored  book chapters and articles in peer-reviewed journals on digital health, wearable technologies, and hospital at home care models. She has spoken on the applications of AI in medicine and the role and design of wearable technologies in clinical practice. She is a graduate of The University of Virginia School of Medicine, and completed her cardiology and electrophysiology fellowship training at Morgan Stanley Children’s Hospital at Columbia University Medical Center and Stanford/UCSF Medical Centers, respectively. 

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

Bio: 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 Research and Innovation Officer, Shriners Children’s

Chief Engineer Pediatric Technologies, Georgia Institute of Technology

President, International Children’s Advisory Network

Bio: 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).