Digital Health 2

Lisa Lavin
Founder, Chairman, and CEO at Omcare

Lisa Lavin is Founder, Chairman, and CEO at Omcare, a digital health company that aims to change the way the world cares by extending the reach of caregivers, increasing medication adherence, and improving treatment outcomes through the power of remote care using interactive video technology. Lisa is a serial entrepreneur with over 25 years of experience building new business from the ground up within the healthcare and high-tech sectors. Lisa is active in local and national organizations that support entrepreneurialism and women in business. Lisa is a Minnesota Cup Division winner, Eureka Award winner for Innovation, was recognized by Minneapolis / St. Paul Business Journal as one of 25 Women to Watch, Minnesota Business’ Real Power 50 and The New York Observer's 2020 List of the Hottest “Flyover Tech” Companies in Digital Health.

Isabel Fulcher, PhD
VP of Data Science at Delfina

Isabel Fulcher, PhD, is VP of Data Science at Delfina, whose mission is Creating a safe, healthy, and supported journey for every pregnancy. Isabel specializes in developing statistical and data science methods to draw insights from complex data sources. She has worked extensively with clinicians and health officials in the United States and Tanzania to improve access to quality reproductive healthcare. As VP of Data Science, she harmonizes rich data sources, innovative data science tools, and the vast clinical expertise at Delfina to build patient-centered technologies that improve pregnancy care for all birthing parents. Isabel has a PhD in biostatistics and was formerly a postdoctoral fellow at the Harvard Data Science Initiative.

Balakrishna Haridas, PhD, FAIMBE, NAI
Texas A&M University

Digital Health Systems for Adverse Event Detection & Management (AEDM) – A Real World Evidence Framework for Pediatric Devices

Abstract: This presentation will focus on discussing the implementation of a new digital health real world evidence based adverse event detection & management system (AEDM) for pediatric T1 Diabetes patients. This real-world evidence (RWE) demonstration project is funded by the FDA P50 Pediatric consortia grant to the Southwest National Pediatric Device Innovation Consortium (SWPDC). The AEDM system predicts hypoglycemic risk in conjunction with contextualization of multimodal consumer health wearables data representing three glycemic risk amplifiers - sleep, exercise & driving. We will discuss how the AEDM platform is now being expanded within to cover a broader set of clinical indications via Biodesign Innovation based needs discovery approach to discover new value creation opportunities for digital data-based RWE studies in pediatric medical devices. Finally, we will share our learnings around challenges in value creation, improving patient outcomes, and barriers to success that exist within the overall framework of digital health systems today to stimulate discussion during the session.

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 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 lead investigator managing the digital data & AEDM system development for Real World Evidence Projects under the SWPDC.

Jessica Falcone
Program Director for NIBIB’s Division of Discovery Science and Technology, NIH

Dr. Jessica Falcone serves as a program director for NIBIB’s Division of Discovery Science and Technology at NIH, and oversees the medical device program at NIBIB. Dr. Falcone has a background in neural engineering and neuroscience. She received her Ph.D. from the Georgia Institute of Technology, where she studied brain electrodes and how to modulate the immune response and blood-brain barrier to extend chronic recordings. She then joined the Bioelectronic Medicine group at the Feinstein Institute of Medical Research and worked on chronic vagus nerve electrodes for murine models. Most recently, Dr. Falcone was a Technical Sales Engineer at Tucker-Davis Technologies (TDT) – a company that builds research systems for neuroscientists. Her technical expertise at TDT included electrophysiology, fiber photometry, auditory, and behavioral control.

Filip Kostal
Medical Alley 

Filip Kostal is Startup Principal at Medical Alley, the world’s foremost network of healthcare organizations.