Agenda | October 14, 2024

10:30 AM

Networking Breakfast and Registration

11:00 AM

Welcome

Kolaleh Eskandanian, Kirstie Keller, Ana Loloei

11:10 AM

Opening Keynote: Thoughtful Considerations for Enhancing Our Impact in Pediatrics

John Konsin, CEO, Prapela

11:30 AM

Make Your Medical Device Pitch for Kids!

12:30 PM

Networking Lunch

1:30 PM

Make Your Medical Device Pitch for Kids!

2:30 PM

Break

2:45 PM

Panel: Bringing Pediatric-Specific Non-Invasive Monitoring Devices to Market

Moderator: Emma Moran

Panelists: Danielle Gottlieb Sen | Peta Alexander | Jonathan Tan | Monty Mythen | Julia Finkel

Synopsis: This panel builds on the insights shared during the April 26, 2024, symposium, produced by Children’s National, CobiCure, and JLABS @DC, on “Pediatric Medical Devices to Address the Heart-Brain Continuum.” At that event, experts discussed the critical need for non-invasive monitoring devices in optimizing neurodevelopmental outcomes for children with congenital heart disease (CHD). As highlighted in the discussions, there remains a significant unmet need for pediatric-specific monitoring devices—most current technologies are adapted from adult models and fail to meet the safety, comfort, and clinical precision required for pediatric use.

In this follow-up panel, our focus will shift to actionable steps for developing and bringing pediatric-specific non-invasive monitoring devices to market. Panelists will discuss the necessary innovations in technology, the regulatory challenges specific to pediatric populations, and strategies for collaboration between clinicians, engineers, and regulatory agencies. We will explore the pathway from concept to market and discuss the future of monitoring devices that address the unique physiological needs of children.

3:45 PM

Break

4:00 PM

Introducing BARDA Accelerator Network 2.0

Ashim Subedee, BARDA and Kolaleh Eskandanian, Children's National

4:10 PM

Building Regional MedTech Ecosystems to Drive Pediatric Innovation with Support from Federal and Regional Agencies

Moderator: Tiffany Wilson (University City Science Center)

Panel Members: Ashim Subedee (BARDA) |Youseph Yazdi (JHU) | Matt Cimino (Maryland Commerce) | Juan Espinoza (CTIP, FDA-funded PDC) |McKay Noll (MPDC, FDA-funded PDC)

Synopsis:This panel will provide actionable insights on how to create strong, sustainable MedTech ecosystems that prioritize pediatric inclusion while benefiting from both regional and federal support. It will explore how regional MedTech ecosystems can drive pediatric innovation, particularly through the inclusion of children in medical device development and the collaboration between government, industry, and academic partners. Participants from BARDA, Johns Hopkins University, Maryland Commerce, and the FDA-funded Pediatric Device Consortia Grant Program will share insights on the role of federal and regional government funding in creating, supporting, and sustaining these ecosystems. Discussions will highlight the importance of aligning resources, policies, and partnerships to ensure pediatric needs are addressed and innovations are accelerated.

4:45 PM

Closing Keynote/Fireside Chat: Reimagining the Home as a Health Care Hub for Children

Synopsis: Join us for an enlightening fireside chat featuring Dr. Michelle Tarver, Acting Director of the FDA's Center for Devices and Radiological Health (CDRH) and a key architect of the "Home as a Health Care Hub" initiative. The conversation will be moderated by Nada Hanafi, founding member of MedTech Color, an organization dedicated to increasing diversity and inclusion in the medical technology industry.

This fireside chat promises to provide a comprehensive look into how the "Home as a Health Care Hub" initiative could transform pediatric healthcare. Attendees will learn about the intersection of technology, design, and policy in creating home-based solutions that could meet the unique needs of children, especially those in underserved communities. The session aims to inspire innovators and healthcare professionals to collaborate in advancing pediatric device innovation and improving health equity for all children.

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