Session Chair:
- Deidra Ansah, Texas Children's Hospital /Baylor College of Medicine
Speakers:
- "Pediatric Pulmonary Flow Restrictor"
Juan Carlos Samayoa, University of Minnesota - "From Implantables to Today's Wearable Tech - A 2026 Perspective"
Alisa Niksch, Owlet Baby Care, Inc. - "From Spark to Light: Engineering Multicenter Validation in Pediatric Device Development"
Danielle Gottlieb Sen, Le Bonheur Children's Hospital and the University of Tennessee Health Science Center
Click on the drop downs below for additional information.
Presentation Details
Juan Carlos Samayoa, MD
Assistant Professor
Division of Pediatric Cardiology
University of Minnesota
"Pediatric Pulmonary Flow Restrictor"
Bio: Dr. Samayoa grew up in Guatemala, where he completed medical school. He then completed two years of research fellowship, followed by residency training and advanced pediatric cardiology training at leading U.S. academic centers. He joined the University of Minnesota in 2023 as a pediatric interventional cardiologist and specializes in cutting-edge techniques that offer hope and healing to patients facing complex cardiac challenges from birth. Dr. Samayoa is a driving force in cardiovascular research, relentlessly pursuing advancements in congenital cardiac interventions.
Alisa Niksch, MD
Senior Director of Medical Affairs
Owlet Baby Care, Inc.
"From Implantables to Today's Wearable Tech - A 2026 Perspective"
This will be a discussion on the history of cardiac implantable devices, their algorithms, and the influence they had on today's sensor and wearable technologies. Despite these influences, as proof emerged that connected cardiac devices could influence clinical outcomes, the broader digital health industry has had inconsistent recognition of the ecosystem that enabled this success. My career path was driven by a recognition of these successes, and the gaps of a new generation of technology.
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.
Danielle Gottlieb Sen, MD, MPH
Associate Professor of Surgery
Le Bonheur Children's Hospital
University of Tennessee Health Science Center
"From Spark to Light: Engineering Multicenter Validation in Pediatric Device Development"
Pediatric device innovation frequently stalls not because of lack of ideas, but because the systems required to generate regulatory-ready evidence remain fragmented. Multicenter validation is structurally necessary in pediatrics due to small patient populations, physiologic heterogeneity, and increasing expectations for generalizable evidence. However, multicenter studies often encounter operational friction arising from inconsistent institutional processes, measurement frameworks, funding instability, and fragmented data infrastructure. This talk examines these barriers through an engineering lens, framing multicenter validation as a system in which friction can either dissipate energy or produce progress. Using examples from pediatric device development, we explore how harmonization of academic medical center processes, sustainable infrastructure funding, coordinated data networks, and consistent regulatory engagement can transform friction into a productive force. Designing these aligned systems is essential to translating innovation into validated technologies that improve outcomes for children.
Bio: Danielle Gottlieb Sen is a pediatric and congenital heart surgeon. She completed medical school at the University of California San Francisco, General Surgery residency at Harvard/Massachusetts General Hospital, Cardiothoracic Surgery fellowship at Columbia/New York Presbyterian and a Congenital Heart Surgery fellowship at Boston Children’s Hospital. She is board-certified in General Surgery, Cardiothoracic Surgery, and Congenital Cardiac Surgery. She has two Masters degrees, including a Master of Science from UC Berkeley, and a Master of Public Health from Harvard School of Public Health. In addition to being a clinical congenital heart surgeon at Le Bonheur, she maintains an affiliate appointment in the Whiting School of Engineering at Johns Hopkins and leads a research group that is focused on designing and commercializing pediatric monitoring devices. She is one of 22 women congenital heart surgeons in the United States, and is a mom to a 12 year-old son, Aiden
Deidra Ansah, MD, FASE (Chair)
Assistant Professor of Pediatrics
Section of Pediatric Cardiology
Texas Children's Hospital /Baylor College of Medicine
Bio: I am a pediatric cardiologist sub-specializing in non-invasive cardiac imaging. I focus on delivering multi-disciplinary team-based care for high-risk cardiac patients. Beyond clinical work, I am passionate about supporting pediatric device and MedTech entrepreneurs particularly those from underrepresented backgrounds.