Strategy and Solutions
The client is a leading infusion pump manufacturer preparing for a large-scale deployment of 10,000 units across hospital networks. With increasing regulatory scrutiny and cybersecurity risks in connected medical devices, the client required a secure, compliant IoMT platform aligned with FDA 510(k) cybersecurity labeling requirements. To achieve this, the organization partnered with Zymr to design and implement a secure, scalable solution.
The client faced significant challenges in meeting evolving FDA cybersecurity requirements for connected medical devices. Existing device architecture lacked standardized security controls, making it difficult to ensure compliance with frameworks such as NIST 800-213.
The infusion pumps required secure communication, firmware updates, and interoperability with hospital systems. However, there was no centralized platform to manage device connectivity, monitor data, or ensure secure data exchange.
Additionally, vulnerabilities within the system posed risks to patient safety and regulatory approval. Without robust security mechanisms such as secure boot, encryption, and authentication, the product could not pass FDA pre-submission audits.
The client needed a comprehensive IoMT platform that could address cybersecurity risks, enable compliance, and support large-scale hospital deployment.
Zymr enabled the client to build a secure and compliant IoMT platform tailored for infusion pump deployments, ensuring both regulatory approval and operational scalability.
Zymr implemented a secure IoMT architecture aligned with FDA and NIST cybersecurity guidelines, enabling safe and scalable infusion pump operations.
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