MedTech · Development to production
    CASE STUDY

    The drawing is approved, the order is released, and nothing connects the two.

    Design revisions, manufacturing orders and the team's day-to-day work now hang off the same items, so a change in development reaches the shop floor without a person carrying it.

    ISO 13485EU MDR21 CFR 820ISO 14971
    KoddexHalvane MedicalLigne OstéoOrdres de fabrication

    OF-2026-0418 — Vis corticale Ø3,5

    KDX2H8Halvane MedicalOrdre ouvertISO 13485Production
    Content Where-used Activity
    reference_piece
    OST-VC-035
    revision_lancee*
    Plan OST-VC-035 · indice D
    revision_courante*
    Indice E
    quantite
    1 200
    statut*
    En cours
    ecart_de_revision
    1 indice

    Ordre lancé sur l'indice D. L'indice E a été approuvé depuis, avec une modification de congé de tête. L'écart est signalé avant que le lot ne parte : soit l'ordre est relancé, soit la dérogation est tracée.

    ordres_impactes_par_indice_E3
    Namestatut_ordre*ecart*action*
    OF-2026-0418 — Vis corticale Ø3,5En cours1 indiceÀ arbitrer
    OF-2026-0402 — Vis corticale Ø3,5Clôturé1 indiceTracé
    OF-2026-0431 — Vis corticale Ø4,0PlanifiéAucunAucune

    The customer's workspace, anonymised. Real structure, fields and states.

    3
    systems, no connectivity
    1
    graph under all of them
    0
    manual re-entries per release
    Live
    revision the shop floor builds to
    Sector Medical device manufacturingBefore ERP + EPDM + task trackerSymptom Data silos between the threeGoal Continuity to the shop floor

    Anonymised at the customer's request. The company, the device and every figure are changed. The three systems, the silo and the model are as they were.

    WHAT THEY DESCRIBED

    Three tools, each right about its own part, none of them talking.

    WHAT WE BUILT WITH THEM

    The part is the anchor. Orders, revisions and tasks hang off it.

    An ERP that does not know the revision

    Manufacturing orders reference a part number. Which drawing revision that number means today is somewhere else.

    One item, three views

    Design, production and planning read the same part from their own angle instead of holding three records of it.

    An EPDM nobody outside design opens

    Drawing and model revisions are managed properly, and production never sees them without being told.

    The order carries its revision

    A manufacturing order references the exact revision it was released against, so what was built is knowable afterwards.

    A task tracker holding the real work

    What the team is actually doing lives in a board that knows nothing about parts, revisions or orders — and is paid for monthly.

    A revision warns the floor

    Approving a new drawing revision flags the open orders built on the previous one, before the batch runs.

    Technicians in cleanroom gowns assembling medical device components on a stainless steel line
    Three systems that each hold part of the truth, and a monthly fee for the one that holds the least.
    THE MODEL

    Nothing replaced the ERP. Something finally sat under it.

    KoddexHalvane MedicalLigne OstéoOrdres de fabrication

    OF-2026-0418 — Vis corticale Ø3,5

    KDX2H8Halvane MedicalOrdre ouvertISO 13485Production
    Content Where-used Activity
    reference_piece
    OST-VC-035
    revision_lancee*
    Plan OST-VC-035 · indice D
    revision_courante*
    Indice E
    quantite
    1 200
    statut*
    En cours
    ecart_de_revision
    1 indice

    Ordre lancé sur l'indice D. L'indice E a été approuvé depuis, avec une modification de congé de tête. L'écart est signalé avant que le lot ne parte : soit l'ordre est relancé, soit la dérogation est tracée.

    ordres_impactes_par_indice_E3
    Namestatut_ordre*ecart*action*
    OF-2026-0418 — Vis corticale Ø3,5En cours1 indiceÀ arbitrer
    OF-2026-0402 — Vis corticale Ø3,5Clôturé1 indiceTracé
    OF-2026-0431 — Vis corticale Ø4,0PlanifiéAucunAucune
    The customer's workspace, anonymised. Real structure, fields and states.

    What we modelled

    Part
    10 attributes
    ƒ
    Drawing revision
    6 attributes
    Manufacturing order
    9 attributes
    ƒ
    Deviation record
    7 attributes
    Team task
    5 attributes

    From a new revision to the orders it touches

    Approving index E asks one question the three systems could not: which open orders were released on index D.

    OST-VC-035 — Drawing, index E
    OST-VC-035 — Cortical screw Ø3.5
    OF-2026-0418 — open
    Revision gap
    gap = current_index − released_index

    Open orders against the current index

    The list production never had. The right-hand column is computed from the link between order and revision.

    OrdreIndice lancéIndice courantÉcart
    OF-2026-0418DE1 indice
    OF-2026-0431EEAucun
    OF-2026-0402DE1 indice
    OF-2026-0444CE2 indices

    ƒ Écart is computed by Koddex, not typed by anyone.

    One manufacturing order, in full

    Vis corticale Ø3,5

    OF-2026-0418
    Ordre de fabrication·Released against drawing index D · current index E
    ContentWhere-used2Activity
    reference_piece
    OST-VC-035
    revision_lancee
    Indice D
    quantite
    1 200
    ecart_de_revision
    1 indicecurrent_index − released_index
    Deviation records
    DER-2026-014Congé de tête, lot en cours

    What the graph computes

    Order · Revision gap
    = current drawing index minus the index the order was released on

    The question that decides whether a batch runs, is re-released, or runs under a traced deviation.

    Part · Open orders on a stale index
    = count of open orders whose released index is behind the current one

    Turns approving a revision into a decision with a visible consequence, rather than a filing action.

    WHAT CHANGED

    The bridge between design and the floor stopped being a person.

    BeforeAfter
    What an order referencesA part numberA part at a revision
    Approving a revisionA filing actionA list of affected orders
    What the floor builds toWhatever was printedThe referenced revision
    DeviationsAgreed verbally, traced laterAttached to the order
    The three systemsThree records of the same partThree views of one item
    WHAT THIS DOES NOT DO

    Three things worth knowing before you defend this internally.

    It does not replace the ERP

    Manufacturing orders keep being executed where they are executed. What changes is that the order now references a revision, which is the link that was missing.

    Production has to accept a new signal

    A revision gap flag is only useful if somebody is accountable for arbitrating it. Adding the alert without naming that person just adds a red dot.

    The task tracker does not disappear on day one

    Day-to-day work moves last, and only once the parts and orders are trustworthy. Teams that try to move it first end up with two boards.

    Frequently asked questions

    Do we have to drop our ERP or EPDM?

    No. Both keep doing what they do well — orders and drawing revisions. What was missing was a layer underneath where a part, its revision and its order are the same object seen from three angles.

    What does the revision gap actually trigger?

    A decision, not an automation. The order is either re-released against the current index or run under a deviation that is recorded against it. The point is that the choice is made knowingly, before the batch.

    Where do we start?

    With one part family and its open orders. The continuity is visible the first time a new drawing index names the orders released on the old one — which normally takes a few days, not a quarter.