Provisioning Connected Devices and SaMD for Clinical Studies

Connected-device clinical studies often depend on more than the investigational product. A study may require tablets, smartphones, hubs, gateways, chargers, cables, sensors, accessories, user credentials, mobile applications, firmware, cloud access and software as a medical device.

Although these components may come from different suppliers, they must be prepared and controlled as one study-specific system.

Authorize the Complete Study Configuration

Provisioning begins before a device is placed in a box. The sponsor should authorize the ancillary hardware, approved software and firmware versions, security settings, connectivity method, mobile-device-management profile, account structure and configuration rules.

Hardware should be received, inspected, charged, assembled into kits, and serialized or otherwise uniquely identified. The authorized software build should then be installed, with equipment enrolled in mobile device management where required.

Verify Configuration Before Applying Study Labels

Configuration must be verified, not assumed. Documented checks may cover power, battery condition, wireless or cellular connectivity, application launch, account access, device pairing, data transfer, time and regional settings, permissions, and communication with the intended platform.

Study labeling should be applied only after verification so that each labeled unit corresponds to its documented hardware and software state.

Battery-Powered Equipment Creates Shipping Requirements

Before release, the shipper must determine the battery chemistry, watt-hour rating or lithium content, quantity, condition, and whether batteries are installed in equipment, packed with equipment or shipped separately.

Lithium-metal and lithium-ion cells and batteries generally must have passed UN 38.3 design testing, with the applicable test summary available.

Packaging must prevent damage, movement, short circuits and unintended activation. The correct marks, labels, documentation, trained personnel, transport mode, carrier rules and destination requirements must also be identified.

Air Transport Requires Additional Battery Controls

Standalone lithium-ion batteries are limited to a 30% state of charge for air transport and cannot travel as cargo on passenger aircraft.

Under 2026 air-transport provisions, the 30% limit can also apply to lithium-ion batteries packed with equipment, while reduced charge is recommended for batteries contained in equipment.

Damaged, defective, swollen, leaking or recalled batteries require separate assessment and are forbidden from air transport.

Map Every Identifier Within the Kit

Traceability becomes more complex when one kit contains several identifiers. The provisioning record may need to connect the kit number, hardware serial number, IMEI, SIM or eSIM identifier, MAC address, asset tag, battery type, application and firmware versions, SaMD release, mobile-device-management record, user assignment, site, shipment and return status.

Control Returns and Re-Provisioning

Shipment, replacement, return and re-provisioning must remain within the same controlled process.

Returned equipment should be reconciled, inspected, quarantined where necessary, wiped under approved security and privacy requirements, and either retired or re-provisioned.

Return instructions must also account for battery condition, compliant packaging, required marks and the permitted transport method.

Establish an Integrated Provisioning Workflow

MDD Options can help sponsors establish and operate an integrated provisioning and distribution workflow for connected study equipment and SaMD.

Services can include ancillary sourcing, kit assembly, serialization, software installation, configuration and connectivity verification, identifier mapping, compliant battery shipping, replacement, return, secure wiping, reconciliation and re-provisioning under sponsor-authorized instructions and documented escalation controls.