In August 2026, the Medical Devices Template Team released version 1.4.0. It targets two areas that come up constantly in medical device implementation projects: giving shop floor operators a lightweight, scan-driven way to work from mobile devices, and tightening the controls around changing or deleting Data Collection readings. In addition, 1.4.0 also ships three smaller, but important enhancements to existing capabilities — Continuous Flows, eDHR Validation and Sign-off, and Automatic Explicit Add.
In this post, we’ll walk through the highlights from 1.4.0, with a closer look at the items described above.
Summary
The table below summarizes what’s new in Medical Devices Template 1.4.0.
| Feature | Description |
|---|---|
| Operator Cockpit for Mobile Devices | A lightweight, scan-driven Operator Cockpit for Zebra mobile devices, covering Check-In, Dispatch, Track-In and Track-Out operations directly at the resource. |
| Prevent User from Removing/Correcting Readings | New Data Collection configuration to block the removal or correction of previously posted reading values, with an optional override role. |
| Continuous Flows — Support Line Clearance | Line Clearance / Resource Setup can now be resolved at Continuous Flow group level, so setup is only required on the Track-In of the first Material of each manufacturing lot. |
| eDHR Validation and Sign-off — Regenerate Report on Demand | Authorized users can now re-trigger report generation for a previously attached eDHR report directly from the Protocol Instance page. |
| Automatic Explicit Add — “Skip Confirmation” Prevent Change Default Value | The default value of the Skip Confirmation flag can now be locked down, so only users in a configured role are allowed to change it. |
You can find the full list of work items in this minor release in the Release Notes.
Operator Cockpit for Mobile Devices
In the shop-floor environment, some of the most common operator actions include checking into a resource, dispatch a Material, track it In, and later track it out — and today that means navigating the full MES interface and using the standard MES pages. That works fine on a desktop terminal, but it’s a different story on a handheld device with a small screen and a built-in barcode scanner. The standard MES pages weren’t designed for those use cases, and forcing operators to zoom, scroll and tap through those screens adds friction to what should be a repetitive and quick operation.
Operator Cockpit for Mobile Devices addresses this use case directly: it’s a scan-first cockpit built specifically for mobile devices, covering the most repetitive resource-level operations — Check-In, Dispatch, Track-In, and Track-Out — in a compact UI.
The workflow follows the natural sequence an operator performs at a resource:
- Scan the Resource. The operator must scan the barcode of the Resource to begin any operation.
- Check-in into the Resource. If the Resource requires Check-In, the cockpit prompts for it before anything else.
- Browse or search Materials. Once checked in, the cockpit lists Materials at the Resource with system state
Queued, and lets the operator filter by system state or Material name. - Scan (or manually select) a Material. Scanning several materials build up a batch of Materials to act on; scanning the same Material again deselects it.
- Dispatch and Track-In, or Track-Out and Move Next, depending on where the selected Materials sit in the flow.
For cases where a barcode can’t be scanned directly, the cockpit also exposes an Insert Barcode action from the menu bar, letting the operator key in the relevant value manually without breaking the scan-driven flow.
Two things need to be in place before the cockpit can be used on a given Resource:
- The lookup table
MedDevMaterialStateForMobileCockpitmust have data — this drives the system-state filter shown in the UI, it should match the different material states (Queued, In Progress, etc.). - The Resource attributes
MedDevMobileCockpitDefaultDispatchAndTrackInandMedDevMobileCockpitDefaultTrackoutAndMoveNextmust be set totrue.
Known issue
The first time the cockpit is opened, you may run into aLookupTable with Name= was not found in the systemerror. This is a known issue in this release, with a documented workaround available at the end of the feature guide, and a proper fix is expected in a future patch.
Prevent User from Removing/Correcting Readings
Data Collections are at the heart of most medical device manufacturing processes, capturing the readings that ultimately feed into regulatory artifacts like a Device History Record (DHR). By default, nothing stops an operator from going back and changing or removing a value that had already been posted on a Data Collection instance — which is a problem in a regulated environment where the integrity of a reading, once recorded, matters.
Prevent User from Removing/Correcting Readings closes this gap with a simple, configuration-driven switch. Set the new Data Collection attribute MedDevPreventChangeReadings to true, and any subsequent attempt to modify or remove a previously posted value on that Data Collection instance is blocked — whether the post happens through the standard Post Data action, during a Process Material step, or at Track-Out.
However, there are legitimate cases (a quality investigation, an authorized correction) where someone needs to be able to override this behavior. That’s what the second half of the feature is for: the MedDevOverridePreventChangeReadingsRole attribute lets you name a role that’s an exception from the restriction. If the current user belongs to that role, changes and removals are allowed to go through as before; everyone else is subject to the restriction.
When a change is attempted, the system doesn’t just fail silently — it returns a clear error identifying exactly which data points (Parameter / Sample / Reading) were affected.
This gives you a single, template-level mechanism to enforce “write-once” readings where it matters, without having to build custom validation logic per project.
Other Enhancements
Alongside these two new features, 1.4.0 delivers three more targeted improvements — one each to Continuous Flows, eDHR Validation and Sign-off, and Automatic Explicit Add.
Continuous Flows: Support Line Clearance
Line Clearance (Resource Setup) ensures a Resource is properly prepared before it starts processing a Material, helping prevent product mix-ups and contamination.
With this enhancement, Line Clearance can now be resolved at the Continuous Flow group level: change-over setup is triggered based on a change in the Material’s ManufacturerLotNumber, rather than on every individual Material. In practice, this means setup is only required on the Track-In of the first Material of each manufacturing lot — subsequent chunks of the same lot flowing through the same Resource don’t force a redundant setup.
Enabling this is a two-step configuration:
- On the Resource, set Setup Mode to
On Change Over. - On the Step, set Setup Characteristic to
Rule, and assign the new template ruleMedDevContinuousFlowSetupCharacteristic, which resolves the characteristic based on the Material’sManufacturerLotNumber.
eDHR Validation and Sign-off: Regenerate Report on Demand
Back in 1.3.0, we introduced eDHR Validation and Sign-off, which automates the association of Materials to a Validation Protocol and the generation of Stimulsoft-based reports at configured Steps. At the time, we mentioned that on-demand regeneration was on the roadmap for the next version — it’s now here.
If a previously generated eDHR report needs to be reissued — e.g., after a data correction, or because the original integration entry failed — an authorized user can now trigger a new generation directly from the Protocol Instance page, without needing to reprocess the entire flow.
Two conditions need to be met for the Regenerate Report action to show up:
- The configuration entry
/MedDev/AutoReportGeneration/EnableOnDemandmust be set totrue. - The user must have access to the
MedDev.RegenerateAndAttachReportsystem feature.
Under the hood, every AttachDocument operation is now recorded in a new MedDevMaterialProtocolReportData generic table, which acts as a history of report generation events per Protocol Instance. The Regenerate Report wizard reads from this table to list all previously triggered reports (most recent first); once the user picks one, a new GenerateAndAttachReport Integration Entry is created with the same payload as the original and processed asynchronously. The regeneration still respects the Override setting from the original Smart Table configuration, so whether the new PDF replaces the existing attachment or not follows the same rule that governed the first generation.
Automatic Explicit Add: “Skip Confirmation” Prevent Change Default Value
Automatic Explicit Add, also introduced in 1.3.0, lets the system calculate and consume a FIFO-based consumption plan for Explicit Add BOMs, with a Skip Confirmation flag controlling whether the operator reviews the plan before it’s executed. That default value could already be set per project via the GUIElementDefaultValue generic table — but nothing stopped an operator from simply flipping the flag in the wizard, regardless of the intended default.
A new security functionality, MedDev.AutomaticExplicitAdd.OverrideSkipConfirmationDefault, now determines whether a user is allowed to change the applied default value in the wizard:
- If the functionality has roles assigned, only users in those roles can override the configured default.
- If the functionality has no roles assigned, the previous behavior is preserved and all users can change it.
This is a small change, but an important one for regulated environments: it means a project can decide, for example, that Skip Confirmation should always stay OFF on a given line, and enforce that decision at the role level.
Wrap Up
While continuing to tighten the compliance and traceability required by regulated environments, version 1.4.0 introduces a first set of enhancements to improve the operator experience. This will remain a key focus in the upcoming versions, with new, dedicated user interfaces and workflows aimed at streamlining daily operations.
Feel free to reach out to the Medical Template Team with questions or feedback on any of these features!
Public Documentation
- Feature Guide — Operator Cockpit for Mobile Devices
- Feature Guide — Prevent User from Removing/Correcting Readings
- Feature Guide — Continuous Flows (Line Clearance)
- Feature Guide — eDHR Validation and Sign-off (on demand)
- Feature Guide — Automatic Explicit Add (Default Skip Confirmation)
- Information Center — Release Notes + Sample Master Data