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Medical Equipment

Connected Device Platform for Infusion and Patient Monitoring Equipment

We built a secure connectivity platform that collects status, alarm and utilisation data from installed devices across hospital networks. Service teams monitor fleet health remotely, and hospitals get utilisation insight without manual rounds.

Mid-sized medical device manufacturer serving Asian and Middle East hospitals (composite) · Medical Equipment

Connected Device Platform for Infusion and Patient Monitoring Equipment

Challenge

Hospital IT security policies and strict separation of patient data. The gateway design kept PHI on premise, sent only operational data outbound, and passed hospital security reviews.

Approach

Devices connect through an on-premise hospital gateway that supports HL7 v2 and IEEE 11073 / SDC-style device data, then forwards de-identified operational data over mutually authenticated TLS to a cloud platform. Device identity is managed with X.509 certificates provisioned at manufacturing. A fleet dashboard shows firmware versions, error codes and utilisation, and supports staged, signed over-the-air updates with rollback. The software was developed under an IEC 62304 lifecycle with ISO 14971 risk management inputs and cybersecurity documentation suitable for regulatory submissions.

Outcome

Remote visibility of device health and firmware across the installed base Illustratively ~25–40% fewer unplanned service visits through proactive diagnosis Faster, controlled rollout of firmware updates Utilisation insight helps hospitals plan device allocation Documentation package supported regulatory and hospital security reviews

✓Remote visibility of device health and firmware across the installed base
~25–40%Illustratively fewer unplanned service visits through proactive diagnosis
✓Faster, controlled rollout of firmware updates

Problem solved

Field service relied on hospital phone calls and periodic site visits. Firmware versions across the installed base were unknown, and hospitals could not see how often devices were actually used.

What we built

Devices connect through an on-premise hospital gateway that supports HL7 v2 and IEEE 11073 / SDC-style device data, then forwards de-identified operational data over mutually authenticated TLS to a cloud platform. Device identity is managed with X.509 certificates provisioned at manufacturing. A fleet dashboard shows firmware versions, error codes and utilisation, and supports staged, signed over-the-air updates with rollback. The software was developed under an IEC 62304 lifecycle with ISO 14971 risk management inputs and cybersecurity documentation suitable for regulatory submissions.

Benefits

Remote visibility of device health and firmware across the installed base Illustratively ~25–40% fewer unplanned service visits through proactive diagnosis Faster, controlled rollout of firmware updates Utilisation insight helps hospitals plan device allocation Documentation package supported regulatory and hospital security reviews

HL7 v2IEEE 11073X.509mTLSOTA updatesIEC 62304ISO 14971

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