Title:
Demystifying Medical Device SBOMS: Challenges and Best Practices for Manufacturers and Healthcare Providers

Kevin Fu
Professor, Archimedes Center for
Healthcare and Medical Device Cybersecurity, Northeastern University

Matt Hazelett

Chief Operating Officer and Chief Quality Officer at MedSec

Soundharya Nagasubramanian

VP, Connectivity & Data Management at Vapotherm

David Nathans

CISO/IT/OT Cybersecurity Officer at Siemens Healthineers

Chris Reed

Sr. Director of Cybersecurity Policy | Global Regulatory Affairs at Medtronic

Axel Wirth

Chief Security Strategist at Medcrypt

Title:
Demystifying Medical Device SBOMS: Challenges and Best Practices for Manufacturers and Healthcare Providers

Speakers: Matt Hazelett /MedSec, Soundharya Nagasubramanian/Vapotherm, Chris Reed/Medtronic, Axel Wirth/Medcrypt and Kevin Fu/Archimedes Center for
Healthcare and Medical Device Cybersecurity

Abstract:
Software Bills of Materials (SBOMs) have emerged as a critical tool for understanding and managing cybersecurity risks in connected medical devices. Despite regulatory emphasis by the FDA and mandatory industry adoption, significant challenges remain in creating, maintaining, and effectively using SBOMs throughout the lifecycle of a medical device. We will explore the SBOM ecosystem in healthcare, from premarket creation to postmarket monitoring, examining the perspectives from both manufacturers and the healthcare delivery organizations.