Typical clinical uses
- Large-volume IV infusion pumps
- Smart syringe and PCA pumps
- Ambulatory and home infusion pumps
- Insulin and specialty drug-delivery pumps
- Connected auto-injectors and on-body delivery systems
MedTech segment · Infusion / Drug Delivery
Infusion & Drug Delivery cybersecurity.
Cybersecurity for infusion pumps and connected drug delivery.
What we mean by infusion / drug delivery.
Infusion pumps were the original FDA cybersecurity story and remain a focus for both pre- and postmarket scrutiny. We help pump and connected-delivery manufacturers harden drug-library distribution, EHR interoperability, and network management interfaces.
Infusion pumps and connected drug-delivery devices have been the highest-volume target of FDA cybersecurity advisories. Hospital security teams now expect mature MDS2, SBOM, and pen test summaries up front - and a postmarket plan that addresses end-of-life components in already-deployed fleets.
Reviewers expect threat models that explicitly assume the hospital network is hostile, not friendly, and that document a signed, rollback-safe field-update mechanism.
Key data flows & integrations
- Pump ↔ hospital Wi-Fi (WPA-Enterprise, certificate-based)
- Pump ↔ drug-library / DERS server (signed payloads)
- Pump ↔ EHR (HL7, infusion documentation)
- Pump ↔ field-service / asset-management tools (authenticated)
- Pump ↔ manufacturer cloud for telemetry (where applicable)
Threat surface
Cyber risks specific to infusion / drug delivery.
Drug library distribution
Drug-library updates are a high-impact target - they need signed payloads and verified delivery.
Hospital network exposure
Pump fleets sit on hospital VLANs with ASTM, HL7, and SNMP exposed - frequently with default credentials.
Postmarket vulnerability response
Long device lifetimes require an active SBOM monitoring and CVD program.
Top concerns
Top cybersecurity concerns for infusion / drug delivery.
Infusion pumps and connected drug-delivery devices have been the highest-volume target of FDA cybersecurity advisories - hospital security teams now expect mature evidence.
- Drug-library tampering and dose-rate manipulation
- Wireless network configuration weaknesses (Wi-Fi, WPA-Enterprise)
- Outdated embedded OSes and unpatched components
- Default / shared service credentials on pumps
- Telnet/FTP-style legacy management interfaces still enabled
- Hardcoded keys in firmware images
- MDS2 inconsistency with the actual deployed configuration
- Postmarket SBOM monitoring against new CVEs
Operational challenges
Where infusion / drug delivery teams get stuck.
Long product life vs. EOL components
Pumps in service for 10-15 years run components that go end-of-life - postmarket plans must address compensating controls.
Hospital network as untrusted
Reviewers expect threat models that assume the hospital network is hostile, not friendly.
Field-update logistics
Field-service updates to deployed fleets need authenticated, signed, and rollback-safe channels - documented in the SPDF.
What FDA scrutinizes
Reviewer focus areas
Drug-library integrity
DERS and drug-library updates must be authenticated, signed, and tamper-evident - reviewers cite this directly.
End-of-life components
10-15 year fleets run components that go EOL; postmarket plans must document compensating controls.
Regulatory pathways and standards
Regulatory pathways
FDA pathways we support
510(k) PMA Supplement
Standards & guidance
Applicable standards
FDA 2026 Premarket Cyber Guidance AAMI SW96 IEC 62304 ISO 14971 IEC 80001-1
Services
How we help infusion / drug delivery teams.
FAQs
Infusion / Drug Delivery cybersecurity FAQs.
How do you test pumps without a hospital network?
We rebuild a representative segment in our lab - switch, EHR simulator, and management server - and run authenticated and unauthenticated tests against it.
Is drug-library distribution in scope for cyber?
Yes, explicitly. Drug libraries are safety-critical configuration data - we test the signing, distribution, verification, and rollback path.
What about legacy pumps already deployed?
We help you stand up a postmarket program: SBOM monitoring, CVD intake, vulnerability disclosures, and a documented patching strategy aligned to FDA postmarket guidance.
Do you cover the pump server / management station?
Yes - the management server is treated as a connected system component with its own threat model, OS hardening review, and pen test.
How do you handle interoperability with hospital EHRs?
HL7/FHIR endpoints are tested for authentication, authorization, and parser robustness. We document the assumptions on the hospital network in your IFU and MDS2.
Can you support a 510(k) Special for a cyber-only change?
Yes - we deliver a focused delta threat model, updated SBOM, and targeted test report scoped to the cyber change so reviewers can clear it quickly.
Infusion pump cybersecurity
Meet FDA expectations for your infusion or drug-delivery device.
Network and protocol testing, drug library integrity, and post-market patching strategy for connected pumps.
- 30-min discovery call
- Fixed-fee proposal in 48 hrs
- No sales pressure
Other segments
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In their words
Backed by MedTech leaders.
HT
"Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
Hank Tucker
CEO · MedTech Manufacturer
For Infusion / Drug Delivery
Get Infusion / Drug Delivery cybersecurity that lands.
Cybersecurity for infusion pumps and connected drug delivery.