The medical device industry operates at the intersection of innovation and responsibility, where safeguarding patient lives and ensuring compliance with stringent regulations are equally critical. Effective Software Bill of Materials (SBOM) management has emerged as an essential strategy for navigating cybersecurity and regulatory challenges in this high-stakes environment.
Unique Challenges Facing Medical Device Manufacturers
Medical device manufacturers face challenges: evolving regulations, complex supply chains, and maintaining stakeholder confidence.
The Shifting Regulatory Horizon
Regulatory bodies, including the FDA, increasingly emphasize transparency and robust lifecycle management of SBOMs. New requirements demand precision and agility, and failure to comply could lead to delays, denied approvals, or even recalls. Without effective SBOM management practices, organizations risk regulatory penalties and damage to their reputations.
Elevated Risk of Compromise
Medical device organizations face a significantly higher risk of cyber compromise compared to other healthcare sectors. According to SecurityScorecard’s 2024 “The Cyber Risk Landscape of the U.S. Healthcare Industry” report, medical device and equipment companies scored 2-3 points lower in security ratings than the overall healthcare sample. These organizations also experienced a 16% higher rate of reported breaches and compromised machines. This underscores the urgency for tailored cybersecurity solutions to mitigate risks and maintain trust.
Complex Supply Chains
Medical devices often depend on a vast ecosystem of suppliers, legacy components, and third-party software. Managing vulnerabilities across this intricate supply chain is vital to ensure both security and compliance. A single overlooked vulnerability could compromise device functionality, patient safety, and trust.
Maintaining Stakeholder Confidence
Trust is the foundation of the medical device industry. Manufacturers must demonstrate to regulators, healthcare providers, and patients that their devices remain secure throughout their lifecycle. Achieving this requires proactive and transparent software supply chain risk management.
The Case for MedTech Expertise
Generic cybersecurity solutions often fall short of addressing the specific needs of medical device manufacturers. MedTech expertise brings critical advantages, including:
- Specialized Knowledge: A deep understanding of the interplay between compliance, safety, and innovation ensures that SBOM management practices align with regulatory and industry demands.
- Tailored Approaches: Customized solutions that meet manufacturers where they are—whether implementing SBOM practices for the first time or optimizing mature vulnerability management processes—allow for greater adaptability and effectiveness.
Best Practices for SBOM Lifecycle Management
To navigate these challenges effectively, medical device manufacturers should adopt strategies that ensure comprehensive SBOM management:
- Automating Compliance: Streamlining the creation and management of SBOMs to align with FDA requirements and global standards minimizes friction and accelerates time to market.
- Integrating Deployed and Build SBOMs: Combining these elements provides a complete view of vulnerabilities across the software supply chain, enabling informed, proactive decision-making.
- Fostering Stakeholder Confidence: A proactive approach to supply chain risk management builds trust among regulators, healthcare providers, and patients, solidifying the manufacturer’s reputation.
Setting a New Standard for SBOM Cybersecurity
The regulatory and threat landscape will continue to evolve, demanding a forward-thinking approach to SBOM management. MedTech expertise is no longer optional but critical in ensuring patient safety, regulatory compliance, and operational excellence. By embracing comprehensive SBOM practices, medical device manufacturers can safeguard their products, protect their patients, and set new benchmarks for security and trust in the industry.
About the Author
Ken Zalevsky is the CEO of Vigilant Ops, Inc. He is a passionate advocate for the application of advanced technology to improve cybersecurity across all industries.
He has collaborated with the United States Food and Drug Administration, US Department of Homeland Security, and the National Telecommunications and Information Administration (NTIA) on various cybersecurity initiatives, including cyber simulation exercises, industry guidance documents, and most recently, SBOM initiatives.
Ken has been a featured speaker at numerous cybersecurity conferences over the years and actively participates on various cybersecurity industry working groups. He has authored numerous cybersecurity whitepapers, blogs, magazine articles, and his work has been published in various industry journals, where he has advised medical device manufacturers on cybersecurity best practices and coached hospitals as they continually struggle with record numbers of breaches.
Ken is a certified Cybersecurity Leader from the School of Computer Science at Carnegie Mellon University and earned an undergraduate degree in Applied Math and a graduate degree in Business Management, both from Carnegie Mellon University. Ken also attended the Executive Education program at Harvard Business School
Ken can be reached online at [email protected] and at our company website www.vigilant-ops.com
