Connected medical devices — devices that transmit data to other systems, networks, or the internet — are reshaping healthcare delivery. From wearable cardiac monitors to connected insulin pumps to remote-capable surgical tools, connectivity enables clinical workflows that were impossible with standalone devices. For manufacturers, the shift to connected devices also introduces new engineering challenges, regulatory requirements, and business model opportunities.

This guide covers everything a medical device manufacturer needs to understand about building, certifying, and scaling a connected medical device.

What Is a Connected Medical Device?

A connected medical device is any medical device that communicates data to or from another device, network, gateway, or cloud platform. The connection may be wired or wireless, continuous or intermittent, local or remote. Examples include:

• Continuous glucose monitors (CGMs) — transmit readings via BLE to a smartphone or dedicated receiver

• Implantable cardiac devices — transmit telemetry data via proprietary RF to an in-home gateway that forwards it to a clinical server

• Hospital infusion pumps — connected to the hospital Wi-Fi network for drug library updates and dose tracking

• Remote blood pressure cuffs — transmit readings via Wi-Fi or cellular to an RPM platform

• Smart inhalers — log usage events and transmit them to a patient app for adherence tracking

Connectivity Options for Medical Devices

Bluetooth Low Energy (BLE)

BLE is the dominant short-range wireless protocol for consumer and clinical wearables. It offers low power consumption, strong smartphone support, and a mature ecosystem of chips and development tools. BLE is well suited for devices that pair to a smartphone or dedicated reader, which then handles the longer-range internet connection. Limitations include a range of approximately 10 meters and the requirement for a paired intermediary device to reach the cloud.

Wi-Fi

Wi-Fi enables direct internet connectivity without an intermediary device, making it suitable for larger devices that operate in a fixed location such as hospital equipment, home diagnostic devices, and bedside monitors. Wi-Fi consumes significantly more power than BLE, making it less suitable for battery-powered wearables.

Cellular (LTE-M and NB-IoT)

Cellular connectivity allows devices to connect directly to the internet from any location with carrier coverage, without relying on a paired smartphone or local Wi-Fi network. LTE-M and NB-IoT are low-power wide-area network (LPWAN) standards optimized for IoT devices, offering better battery life than standard LTE. Cellular is well suited for emergency response devices, remote area deployments, and devices worn by patients with limited technical literacy.

Proprietary RF

Implantable devices often use proprietary RF protocols operating in the MICS band (402-405 MHz) for transcutaneous communication with external programmers or monitoring equipment. These protocols prioritize reliability and low power over interoperability.

Data Architecture for Connected Medical Devices

Device identity and authentication

Each device must have a unique identity that is verified before any data is accepted by the cloud backend. Hardware-rooted device identity, using certificates stored in a secure element or TPM, provides the strongest assurance. Software-only credentials are more vulnerable to extraction and impersonation.

Data models and standards

Defining a clear data model early in the design process prevents costly rework later. HL7 FHIR is increasingly used as the standard data format for health data, facilitating interoperability with EHR systems. For device-side data, manufacturers often use lightweight JSON or binary formats that are translated to FHIR at the cloud ingestion layer.

Edge processing

In some architectures, a portion of data processing occurs on the device or a local gateway before data is sent to the cloud. Edge processing can reduce latency, lower data transmission costs, and provide a degree of functionality when cloud connectivity is unavailable. However, it adds complexity to the software architecture and must be managed carefully from a regulatory perspective.

Regulatory Requirements for Connected Medical Devices

Connected medical devices face regulatory requirements that go beyond those for standalone devices. Key areas include:

Software as a Medical Device (SaMD)

If the software running on or connected to your device performs a medical function independently of the hardware, it may be classified as SaMD and subject to independent regulatory review. Manufacturers should evaluate SaMD classification early and design their software architecture accordingly.

Cybersecurity

The FDA requires manufacturers to address cybersecurity throughout the device lifecycle, including in premarket submissions. See our guide on medical device cybersecurity for a full overview of requirements and best practices.

Post-market surveillance

Connected devices generate data that enables real-world performance monitoring at a scale that was not previously possible. Regulators increasingly expect manufacturers to use this data for proactive post-market surveillance, identifying safety signals before they become reportable adverse events.

The Business Case for Connectivity

Beyond regulatory compliance, connectivity creates tangible business value for device manufacturers:

• Recurring revenue — connected devices enable subscription-based service models that increase customer lifetime value

• Faster product iteration — OTA firmware updates allow manufacturers to improve products after shipment

• Clinical evidence generation — real-world data from connected devices supports label expansions and differentiated clinical claims

• Customer retention — connectivity creates switching costs and ongoing engagement with the patient and provider

Related Resources

Explore related topics to deepen your understanding of medical device connectivity and compliance:

• Medical Device Cybersecurity: A Complete Guide

• How to Connect a Medical Device to the Cloud

• Cloud-Based Medical Devices: Architecture and Compliance

• Remote Patient Monitoring Platform