Medical Device Integration Services

Medical device integration is the software that moves measurements from devices such as blood pressure cuffs, pulse oximeters, glucose meters, bedside monitors and wearables into clinical systems. It covers the connection to the device or its cloud, decoding and normalization, association with the right patient, delivery to the EHR or your product and monitoring of the whole path.

Standard Bluetooth health devices, Apple HealthKit and Android Health Connect, manufacturer clouds for cellular cuffs, scales, CGMs and wearables, and hospital monitors, pumps and vitals carts through device gateways that emit HL7 v2. When a device has no public interface we assess its SDK, GATT service or export format and build the connector.

IEEE 11073 is the family of standards for medical device communication. The 20601 exchange protocol and the 104xx specializations cover personal health devices, the 10101 nomenclature supplies the MDC codes used across devices and gateways, and SDC covers networked point-of-care devices. You need it when your devices or gateways speak it, and its codes are useful even when they do not.

Two routes. Hospital device gateways send HL7 v2 ORU^R01 messages under the IHE PCD Device Enterprise Communication profile into the EHR's device integration module, where nurses validate readings before they chart. Remote monitoring products usually write FHIR Observations or send ORU^R01 through an interface the health system enables. We scope which route each customer supports.

Association is designed per setting. Home devices are bound to a patient at enrollment by serial number or UDI, shared stations open a session per person and reset afterward, and bedside devices are associated through the gateway and the patient's encounter. Unmatched readings go to a review queue instead of guessing.

Software that only transfers, stores, converts or displays device data is a medical device data system under 21 CFR 880.6310 and is outside the device definition under section 520(o)(1)(D) of the FD&C Act. Software that analyzes device data to drive alarms or active patient monitoring is a device software function. We design the boundary with your regulatory lead.

Yes. We model readings as FHIR R4 Observations with LOINC codes, UCUM units and US Core 6.1.0 vital signs profiles, with Device and DeviceMetric resources for the source and Provenance for how the value arrived. For personal health devices we follow the HL7 Personal Health Device guide, and for hospital devices the Point-of-Care Device guide.

Bluetooth devices store readings and upload them in bursts after reconnect, so we de-duplicate on device, time and value, correct for clock drift and keep the original timestamps. A missing permission or an offline device is reported as missing data, never as a zero, and silence alerts fire when a patient's device stops reporting.

Yes. We build connectors on their own or the full RPM product around them: patient app, care team dashboard, review queues, time tracking and billing data. Our remote patient monitoring software page covers that end-to-end scope.

A first device family into one product typically takes 8 to 14 weeks. Device access and vendor agreements, the number of models and any EHR write-back set most of the date. Each additional model on the same standard profile is much faster because the connector and mappings already exist.

Cost depends on the number of device models, the transport, whether you write back to an EHR, the patient association model, the clinical rules and the support level. We give a fixed scope and price after one scoping call.

Yes. Device readings become PHI once linked to a patient. We sign Business Associate Agreements, encrypt data in transit and at rest, keep audit logs and work inside our ISO 27001:2022 certified management system.