An Interface Is Done When the Customer Can Use It Without You
Interoperability Definition of Done
Companion to Medical Device Connectivity · Updated 2026-09-29
Use this as the release gate for any interface: an integration is done when a customer can use it without the manufacturer’s engineers in the room. Product managers and interoperability engineers own it; “Manufacturers Should Ship Integration With a Kit and Support” works it on the bedside monitor.
Mark each item done, partly done, or not done.
- The meaning of every element is documented, including units, identities, and provenance, from a completed Event/State/Command Modeling Worksheet.
- The interface is documented and versioned, the version policy is published, and each unit reports its interface version to the fleet view.
- The standards and profiles the interface implements are stated with their versions, and conformance is tested wherever a test exists.
- The previous interface version stays supported for a stated period after each new release.
- A simulator or test harness is available to customers and integrators, and it produces the device’s real events, including alarms, faults, and patient disassociation.
- A sandbox is available where integrators can work without a production device.
- A reference integration exists with at least one type of receiving system, in a real workflow.
- Failure behavior is documented, and the interface has passed the Synchronization Test Plan.
- Access is authenticated, and roles are documented.
- An implementation guide and a named support path exist, and the customer’s integration team can get trained.
- The customer can export its data through the interface without vendor assistance.
- Clinical or process users have confirmed that the data arrives where the work happens, with its context.
If any item is not done, don’t call the integration finished. Hold the release, or ship it labeled at the lower maturity level it actually reaches, with a dated roadmap the buyer can write into the contract. Otherwise the customer pays for the gap in integration services, workarounds, or both, and the manufacturer pays for it in support calls.
