{
  "_gtmos": 1,
  "exportedAt": "2026-07-21T00:00:00.000Z",
  "note": "NovintiX worked example — all seven GTM Platform workspaces.",
  "data": {
    "firm": {
      "firmName": "NovintiX",
      "tagline": "MedTech & life-sciences product engineering — from design controls to commercialization",
      "senderName": "[NovintiX Partner]",
      "senderTitle": "Engineering Partner",
      "city": "Coimbatore",
      "capabilities": [
        "Medical device product engineering (design controls & risk management)",
        "Regulatory & quality — UDI, submissions, CAPA, design history files",
        "Clinical affairs & healthcare data engineering",
        "Manufacturing & supply-chain optimization"
      ],
      "keyMessages": [
        "We de-risk device programs concept-to-commercialization — design controls, UDI and submission-ready evidence built in from day one",
        "A specialist MedTech engineering pod that plugs into your GCC without the overhead of a big SI"
      ],
      "products": [
        {
          "name": "UDI Sprint",
          "capability": "Regulatory data engineering",
          "benefit": "GUDID / EUDAMED-ready UDI records in 6 weeks"
        },
        {
          "name": "Design-Control Accelerator",
          "capability": "Device product engineering",
          "benefit": "Audit-ready DHF & risk file for one device family"
        },
        {
          "name": "SaMD Assurance Pack",
          "capability": "Software-as-a-medical-device V&V",
          "benefit": "IEC 62304-aligned evidence a notified body accepts"
        }
      ],
      "proofPoints": [
        "Concept-to-commercialization support: design controls, risk management and regulatory submissions under one roof",
        "MedTech / life-sciences focus — device, diagnostics, SaMD and combination products"
      ],
      "approach": "Founder-led (builder voice)"
    },
    "gcc.icp": {
      "solution": "Specialist MedTech & life-sciences product-engineering + regulatory pods (design controls, UDI, SaMD V&V, clinical data engineering) that plug into a GCC's device programs.",
      "segments": [
        "MedTech Engineering & R&D",
        "Diagnostics & Tools",
        "Manufacturing & Supply Chain / Quality",
        "Pharmacovigilance & Regulatory"
      ],
      "maturity": [
        "New setup (<2y)",
        "Scaling (2–5y)",
        "Mature (5y+)"
      ],
      "sizes": [
        "200 – 500",
        "500 – 1,500",
        "1,500 – 5,000"
      ],
      "geo": [
        "Bengaluru",
        "Hyderabad",
        "Pune",
        "Chennai"
      ],
      "functions": "Device R&D & product engineering, Regulatory affairs & UDI, Quality/CAPA, SaMD & digital health, Clinical data engineering, Manufacturing NPI",
      "buyers": "VP/Head of R&D or Engineering (economic buyer); Head of Regulatory/Quality (champion); Principal/Staff engineers & V&V leads (technical evaluators); Vendor Management/Procurement; EA/Chief of Staff (gatekeeper); device program teams (end users)",
      "pains": "Device programs stall in design-control and submission gaps; UDI/EUDAMED backlog; SaMD V&V evidence a notified body will accept; thin specialist bandwidth inside a scaling GCC; big SIs are too generalist and too expensive for a single device family.",
      "proof": "Concept-to-commercialization pod: design controls, risk files, UDI and regulatory submissions delivered as one accountable scope — MedTech-native, not a generalist SI.",
      "deal": "$25k – $150k (micro-pilot → device-family engagement)",
      "savedAt": "2026-07-15"
    },
    "db.accounts": [
      {
        "id": "nx_medtronic",
        "name": "Medtronic Engineering & Innovation Center (MEIC)",
        "segment": "MedTech R&D",
        "city": "Hyderabad",
        "stage": "Meeting",
        "owner": "NX",
        "functions": [
          "Device R&D",
          "SaMD",
          "Regulatory"
        ],
        "source": "seed",
        "notes": "Largest Medtronic R&D center outside the US. WHY-NOW (2026-06): expanding SaMD & connected-device programs; design-control bandwidth is the constraint. Directional — verify; not affiliated."
      },
      {
        "id": "nx_bsci",
        "name": "Boston Scientific Global Engineering",
        "segment": "MedTech R&D",
        "city": "Pune",
        "stage": "Opportunity",
        "owner": "NX",
        "functions": [
          "Device R&D",
          "V&V",
          "Manufacturing NPI"
        ],
        "source": "seed",
        "notes": "WHY-NOW (2026-07): scaling engineering + NPI; brief for a UDI/DHF remediation pod on one device family. Directional — verify; not affiliated."
      },
      {
        "id": "nx_stryker",
        "name": "Stryker Global Technology Center (SGTC)",
        "segment": "MedTech R&D",
        "city": "Gurugram",
        "stage": "Outreach",
        "owner": "NX",
        "functions": [
          "Device R&D",
          "Robotics",
          "Digital"
        ],
        "source": "seed",
        "notes": "WHY-NOW (2026-05): robotics & digital surgery build-out; risk-management and SaMD V&V demand rising. Directional — verify; not affiliated."
      },
      {
        "id": "nx_ge",
        "name": "GE HealthCare — Bengaluru",
        "segment": "MedTech / Imaging",
        "city": "Bengaluru",
        "stage": "Research",
        "owner": "NX",
        "functions": [
          "Imaging devices",
          "AI/SaMD",
          "Quality"
        ],
        "source": "seed",
        "notes": "Devices, imaging and AI at scale. WHY-NOW: AI-in-imaging SaMD evidence packs. Directional — verify; not affiliated."
      },
      {
        "id": "nx_siemens",
        "name": "Siemens Healthineers — Bengaluru",
        "segment": "MedTech / Imaging",
        "city": "Bengaluru",
        "stage": "Outreach",
        "owner": "NX",
        "functions": [
          "Imaging software",
          "SaMD",
          "Regulatory"
        ],
        "source": "seed",
        "notes": "Imaging software + digital. WHY-NOW: EUDAMED/UDI program load. Directional — verify; not affiliated."
      },
      {
        "id": "nx_bd",
        "name": "Becton Dickinson (BD) — Bengaluru",
        "segment": "MedTech",
        "city": "Bengaluru",
        "stage": "Research",
        "owner": "NX",
        "functions": [
          "Software",
          "Device engineering",
          "Quality"
        ],
        "source": "seed",
        "notes": "Software + engineering hub. WHY-NOW: device-software design-control depth. Directional — verify; not affiliated."
      },
      {
        "id": "nx_baxter",
        "name": "Baxter — Bengaluru",
        "segment": "MedTech / GBS",
        "city": "Bengaluru",
        "stage": "Research",
        "owner": "NX",
        "functions": [
          "Device engineering",
          "Shared services"
        ],
        "source": "seed",
        "notes": "Engineering + shared services. WHY-NOW: supply-chain & manufacturing quality. Directional — verify; not affiliated."
      },
      {
        "id": "nx_abbott",
        "name": "Abbott — Devices GBS (Bengaluru)",
        "segment": "MedTech / Diagnostics",
        "city": "Bengaluru",
        "stage": "Outreach",
        "owner": "NX",
        "functions": [
          "Devices",
          "Diagnostics",
          "Engineering"
        ],
        "source": "seed",
        "notes": "Devices + diagnostics shared services. WHY-NOW: diagnostics NPI + UDI. Directional — verify; not affiliated."
      },
      {
        "id": "nx_jnj",
        "name": "Johnson & Johnson MedTech — Global Services",
        "segment": "MedTech",
        "city": "Bengaluru",
        "stage": "Research",
        "owner": "NX",
        "functions": [
          "MedTech engineering",
          "Digital surgery",
          "Quality"
        ],
        "source": "seed",
        "notes": "Global services + tech. WHY-NOW: digital surgery + SaMD. Directional — verify; not affiliated."
      },
      {
        "id": "nx_snn",
        "name": "Smith+Nephew — Pune",
        "segment": "MedTech / GBS",
        "city": "Pune",
        "stage": "Research",
        "owner": "NX",
        "functions": [
          "Engineering",
          "Business services"
        ],
        "source": "seed",
        "notes": "Engineering + business services. WHY-NOW: device-family engineering support. Directional — verify; not affiliated."
      },
      {
        "id": "nx_thermo",
        "name": "Thermo Fisher — Diagnostics & Tools (Bengaluru)",
        "segment": "Diagnostics & Tools",
        "city": "Bengaluru",
        "stage": "Research",
        "owner": "NX",
        "functions": [
          "Instruments software",
          "Diagnostics",
          "Quality"
        ],
        "source": "seed",
        "notes": "Instruments + software + shared services. WHY-NOW: IVDR/UDI & instrument software V&V. Directional — verify; not affiliated."
      },
      {
        "id": "nx_philips",
        "name": "Philips Innovation Campus — Bengaluru",
        "segment": "MedTech / Health Tech",
        "city": "Bengaluru",
        "stage": "Won",
        "owner": "NX",
        "functions": [
          "Imaging",
          "Digital health",
          "SaMD"
        ],
        "source": "seed",
        "notes": "Imaging + digital health. WON (2026-07): UDI Sprint micro-pilot on one connected-device line — the reference logo. Directional — verify; not affiliated."
      }
    ],
    "db.contacts": [
      {
        "id": "nx_c1",
        "name": "[VP, Device R&D — MEIC]",
        "title": "VP / Head of Device R&D",
        "accountId": "nx_medtronic",
        "accountName": "Medtronic Engineering & Innovation Center (MEIC)",
        "city": "Hyderabad",
        "persona": "Economic buyer",
        "warmth": "warm",
        "lastTouch": "2026-06-24",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Economic Buyer"
        ],
        "notes": "Owns the device-engineering P&L for the center. Role placeholder — identify the real person before outreach."
      },
      {
        "id": "nx_c2",
        "name": "[Head of Regulatory & Quality — MEIC]",
        "title": "Head of Regulatory Affairs & Quality",
        "accountId": "nx_medtronic",
        "accountName": "Medtronic Engineering & Innovation Center (MEIC)",
        "city": "Hyderabad",
        "persona": "Champion",
        "warmth": "warm",
        "lastTouch": "2026-06-20",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Champion"
        ],
        "notes": "Feels the UDI/submission pain first — natural champion."
      },
      {
        "id": "nx_c3",
        "name": "[Principal SaMD V&V Engineer — MEIC]",
        "title": "Principal Engineer, SaMD V&V",
        "accountId": "nx_medtronic",
        "accountName": "Medtronic Engineering & Innovation Center (MEIC)",
        "city": "Hyderabad",
        "warmth": "cold",
        "tags": [
          "gcc",
          "role-placeholder",
          "bc:Technical Evaluator"
        ],
        "notes": "Judges whether the evidence approach is credible."
      },
      {
        "id": "nx_c4",
        "name": "[Vendor Management Lead — MEIC]",
        "title": "Procurement / Vendor Management",
        "accountId": "nx_medtronic",
        "accountName": "Medtronic Engineering & Innovation Center (MEIC)",
        "city": "Hyderabad",
        "warmth": "cold",
        "tags": [
          "gcc",
          "role-placeholder",
          "bc:Procurement & Vendor Management"
        ],
        "notes": "Owns MSA, rate card, security review."
      },
      {
        "id": "nx_c5",
        "name": "[Chief of Staff — MEIC]",
        "title": "Chief of Staff / EA to the Site Head",
        "accountId": "nx_medtronic",
        "accountName": "Medtronic Engineering & Innovation Center (MEIC)",
        "city": "Hyderabad",
        "warmth": "cold",
        "tags": [
          "gcc",
          "role-placeholder",
          "bc:Gatekeeper"
        ],
        "notes": "Controls calendar access to the site head."
      },
      {
        "id": "nx_c6",
        "name": "[Device Program Team — MEIC]",
        "title": "Program / Project Engineers (end users)",
        "accountId": "nx_medtronic",
        "accountName": "Medtronic Engineering & Innovation Center (MEIC)",
        "city": "Hyderabad",
        "warmth": "cold",
        "tags": [
          "gcc",
          "role-placeholder",
          "bc:End Users"
        ],
        "notes": "The team the pod works alongside day to day."
      },
      {
        "id": "nx_c7",
        "name": "[Director, Engineering & NPI — BSC Pune]",
        "title": "Director, Engineering & NPI",
        "accountId": "nx_bsci",
        "accountName": "Boston Scientific Global Engineering",
        "city": "Pune",
        "persona": "Economic buyer",
        "warmth": "warm",
        "lastTouch": "2026-07-08",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Economic Buyer"
        ]
      },
      {
        "id": "nx_c8",
        "name": "[Head of Quality Systems — BSC Pune]",
        "title": "Head of Quality Systems / CAPA",
        "accountId": "nx_bsci",
        "accountName": "Boston Scientific Global Engineering",
        "city": "Pune",
        "persona": "Champion",
        "warmth": "warm",
        "lastTouch": "2026-07-05",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Champion"
        ]
      },
      {
        "id": "nx_c9",
        "name": "[Staff V&V Engineer — BSC Pune]",
        "title": "Staff Engineer, Verification & Validation",
        "accountId": "nx_bsci",
        "accountName": "Boston Scientific Global Engineering",
        "city": "Pune",
        "warmth": "cold",
        "tags": [
          "gcc",
          "role-placeholder",
          "bc:Technical Evaluator"
        ]
      },
      {
        "id": "nx_c10",
        "name": "[Procurement — BSC Pune]",
        "title": "Procurement / Vendor Management",
        "accountId": "nx_bsci",
        "accountName": "Boston Scientific Global Engineering",
        "city": "Pune",
        "warmth": "cold",
        "tags": [
          "gcc",
          "role-placeholder",
          "bc:Procurement & Vendor Management"
        ]
      },
      {
        "id": "nx_c11",
        "name": "[Head of Digital Surgery Eng — Stryker SGTC]",
        "title": "Head of Digital Surgery Engineering",
        "accountId": "nx_stryker",
        "accountName": "Stryker Global Technology Center (SGTC)",
        "city": "Gurugram",
        "persona": "Economic buyer",
        "warmth": "cold",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Economic Buyer"
        ]
      },
      {
        "id": "nx_c12",
        "name": "[Regulatory Lead — Stryker SGTC]",
        "title": "Regulatory Affairs Lead",
        "accountId": "nx_stryker",
        "accountName": "Stryker Global Technology Center (SGTC)",
        "city": "Gurugram",
        "persona": "Champion",
        "warmth": "cold",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Champion"
        ]
      },
      {
        "id": "nx_c13",
        "name": "[Head of SaMD Regulatory — Siemens Healthineers]",
        "title": "Head of SaMD Regulatory",
        "accountId": "nx_siemens",
        "accountName": "Siemens Healthineers — Bengaluru",
        "city": "Bengaluru",
        "persona": "Champion",
        "warmth": "cold",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Champion"
        ]
      },
      {
        "id": "nx_c14",
        "name": "[Head of Diagnostics NPI — Abbott]",
        "title": "Head of Diagnostics NPI",
        "accountId": "nx_abbott",
        "accountName": "Abbott — Devices GBS (Bengaluru)",
        "city": "Bengaluru",
        "persona": "Economic buyer",
        "warmth": "cold",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Economic Buyer"
        ]
      },
      {
        "id": "nx_c15",
        "name": "[Program Lead, Connected Devices — Philips]",
        "title": "Program Lead, Connected Devices",
        "accountId": "nx_philips",
        "accountName": "Philips Innovation Campus — Bengaluru",
        "city": "Bengaluru",
        "persona": "Champion",
        "warmth": "strong",
        "lastTouch": "2026-07-14",
        "tags": [
          "exec",
          "gcc",
          "role-placeholder",
          "bc:Champion",
          "reference"
        ],
        "notes": "Sponsor of the won UDI Sprint micro-pilot — reference & case-study source."
      }
    ],
    "db.gcc.plays": [
      {
        "id": "nx_pl1",
        "name": "UDI/DHF remediation pod — Boston Scientific",
        "short": "UDI/DHF remediation",
        "status": "Active",
        "accountIds": [
          "nx_bsci"
        ],
        "notes": "Land on one device family with a scoped UDI + design-history-file remediation micro-pilot."
      },
      {
        "id": "nx_pl2",
        "name": "SaMD V&V evidence pack — Medtronic MEIC",
        "short": "SaMD V&V evidence",
        "status": "Active",
        "accountIds": [
          "nx_medtronic"
        ],
        "notes": "IEC 62304-aligned V&V evidence for one connected-device workflow."
      },
      {
        "id": "nx_pl3",
        "name": "Digital-surgery risk-file play — Stryker",
        "short": "Digital-surgery risk file",
        "status": "Planned",
        "accountIds": [
          "nx_stryker"
        ],
        "notes": "Risk management (ISO 14971) for a robotics/digital-surgery module."
      },
      {
        "id": "nx_pl4",
        "name": "Reference-expansion — Philips connected devices",
        "short": "Philips expansion",
        "status": "Active",
        "accountIds": [
          "nx_philips"
        ],
        "notes": "Grow the won micro-pilot into a device-family engagement + reference case study."
      }
    ],
    "db.gcc.landscape": [
      {
        "id": "nx_ld1",
        "name": "Global SIs (TCS / Wipro / Cognizant MedTech units)",
        "type": "Competitor",
        "strengths": "Scale, existing MSAs, staffing depth",
        "weaknesses": "Generalist; expensive for a single device family; slow to mobilize a specialist pod",
        "angle": "We are MedTech-native and land in weeks on one scoped device family — not a 12-month transformation."
      },
      {
        "id": "nx_ld2",
        "name": "Regulatory boutiques (device consultancies)",
        "type": "Competitor",
        "strengths": "Deep reg/quality expertise",
        "weaknesses": "Advisory only — hand you a report, not built evidence or engineering",
        "angle": "We build the DHF, the UDI records and the V&V evidence, not just the recommendations."
      },
      {
        "id": "nx_ld3",
        "name": "Captive/in-house GCC teams",
        "type": "Ecosystem",
        "strengths": "Own the program, domain context",
        "weaknesses": "Bandwidth-constrained on specialist design-control & submission work",
        "angle": "We are the flex specialist pod that clears the backlog without adding headcount."
      },
      {
        "id": "nx_ld4",
        "name": "UDI/EUDAMED data platforms",
        "type": "Partner",
        "strengths": "Tooling for UDI submission",
        "weaknesses": "Need services to populate & validate records",
        "angle": "We are the services layer that makes their platform produce audit-ready records."
      }
    ],
    "db.outreach.events": [
      {
        "id": "nx_ev1",
        "name": "Design Controls & UDI in MedTech GCCs — Engineering Roundtable",
        "type": "roundtable",
        "date": "2026-08-21",
        "time": "17:00",
        "venue": "Taj MG Road, Bengaluru",
        "capacity": 12,
        "guests": [
          {
            "contactId": "nx_c2",
            "name": "[Head of Regulatory & Quality — MEIC]",
            "title": "Head of Reg & Quality",
            "accountName": "Medtronic MEIC",
            "status": "Invited",
            "nextTouch": "2026-08-10"
          },
          {
            "contactId": "nx_c8",
            "name": "[Head of Quality Systems — BSC Pune]",
            "title": "Head of Quality Systems",
            "accountName": "Boston Scientific",
            "status": "Accepted",
            "nextTouch": "2026-08-14"
          },
          {
            "contactId": "nx_c15",
            "name": "[Program Lead, Connected Devices — Philips]",
            "title": "Program Lead",
            "accountName": "Philips",
            "status": "Accepted",
            "nextTouch": "2026-08-16"
          }
        ]
      }
    ],
    "db.content.campaigns": [
      {
        "id": "nx_cmp1",
        "name": "Boston Scientific — win the engineering buyer",
        "goal": "gcc",
        "accountId": "nx_bsci",
        "accountName": "Boston Scientific Global Engineering",
        "contactId": "nx_c7",
        "contactName": "[Director, Engineering & NPI — BSC Pune]",
        "startDate": "2026-08-04",
        "createdAt": "2026-07-16",
        "steps": [
          {
            "templateId": "gcc-linkedin-connect",
            "dayOffset": 0,
            "done": true
          },
          {
            "templateId": "gcc-head-charter-firsttouch",
            "dayOffset": 3,
            "done": false
          },
          {
            "templateId": "gcc-peer-operator-open",
            "dayOffset": 8,
            "done": false
          },
          {
            "templateId": "gcc-roundtable-invite",
            "dayOffset": 15,
            "done": false
          },
          {
            "templateId": "gcc-referral-broker",
            "dayOffset": 24,
            "done": false
          },
          {
            "templateId": "graceful-breakup-last-touch",
            "dayOffset": 34,
            "done": false
          }
        ]
      }
    ],
    "launch.products": [
      {
        "id": "nx_pr1",
        "name": "UDI Sprint",
        "oneLiner": "GUDID / EUDAMED-ready UDI records for one device family in 6 weeks — validated, audit-ready, done.",
        "stage": "Building",
        "createdAt": "2026-07-05",
        "positioning": {
          "alternatives": "manual UDI backlog / generalist SI",
          "attributes": "MedTech-native services pod on UDI data + validation",
          "value": "audit-ready UDI records fast",
          "segment": "MedTech GCC regulatory/quality teams",
          "category": "UDI enablement service",
          "trends": "EUDAMED go-live pressure, IVDR",
          "stIcp": "MedTech GCC device families with a UDI backlog",
          "stStruggle": "UDI/EUDAMED records pile up and stall submissions",
          "stValue": "clear the backlog with validated records in weeks",
          "stAlt": "spreadsheets + overloaded reg team",
          "stDiff": "MedTech-native pod that builds and validates the records"
        },
        "icp": {
          "firmo": "MedTech GCC, 200–5,000 seats, active device programs",
          "role": "Head of Regulatory/Quality or Engineering",
          "trigger": "EUDAMED deadline / audit finding / device-family launch",
          "holes": "no specialist UDI bandwidth",
          "wtp": "$25k–$60k per device family"
        },
        "jtbd": [
          {
            "id": "nx_j1",
            "situation": "an EUDAMED/UDI deadline is closing on a device family",
            "motivation": "records validated and submitted without pulling the core team off launch work",
            "outcome": "pass the audit and unblock the submission",
            "imp": 9,
            "sat": 2
          }
        ],
        "pillars": [
          {
            "pillar": "Speed",
            "features": "6-week scoped sprint",
            "benefit": "backlog cleared in weeks not quarters",
            "proof": "Philips micro-pilot"
          },
          {
            "pillar": "Audit-ready",
            "features": "validated records + evidence",
            "benefit": "survives notified-body review",
            "proof": ""
          },
          {
            "pillar": "MedTech-native",
            "features": "device-family literacy",
            "benefit": "no ramp-up tax",
            "proof": ""
          }
        ],
        "objections": [
          {
            "id": "nx_o1",
            "objection": "A big SI already has our MSA",
            "response": "We slot in under your existing vendor framework and land on ONE device family — proof before scale, no 12-month program."
          }
        ],
        "landing": {
          "heroPick": "0",
          "customHeadline": "",
          "subhead": "",
          "socialProof": "Piloted with a connected-device line at a Bengaluru MedTech GCC",
          "how1": "Scope one device family",
          "how2": "Build & validate UDI records",
          "how3": "Hand off audit-ready evidence",
          "plan1": "",
          "plan2": "",
          "plan3": "",
          "ctaLabel": "Book a scoping call",
          "ctaSub": ""
        },
        "checklist": {
          "pre1": true,
          "pre2": true,
          "pre3": true,
          "pre4": true,
          "pre5": false,
          "pre6": false,
          "pre7": false
        }
      }
    ],
    "launch.activeId": "nx_pr1",
    "service.firm": "NovintiX — a MedTech/life-sciences engineering specialist productizing its highest-repeat regulatory & design-control services into fixed-scope offers.",
    "db.service.services": [
      {
        "id": "nx_s1",
        "name": "UDI Sprint",
        "description": "Build & validate GUDID/EUDAMED UDI records for one device family",
        "delivery": "sprint",
        "typicalPrice": "$25k–$60k",
        "effortDays": 30,
        "repeatability": 5,
        "standardization": 5,
        "demand": 5,
        "outcomes": "audit-ready UDI records",
        "toolsIP": "UDI validation checklist + record templates"
      },
      {
        "id": "nx_s2",
        "name": "Design-Control Accelerator",
        "description": "DHF + risk file (ISO 14971) build-out for one device family",
        "delivery": "engagement",
        "typicalPrice": "$60k–$120k",
        "effortDays": 55,
        "repeatability": 4,
        "standardization": 4,
        "demand": 4,
        "outcomes": "audit-ready DHF & risk file",
        "toolsIP": "design-control template library"
      },
      {
        "id": "nx_s3",
        "name": "SaMD Assurance Pack",
        "description": "IEC 62304-aligned V&V evidence for a software-as-a-medical-device workflow",
        "delivery": "engagement",
        "typicalPrice": "$40k–$90k",
        "effortDays": 40,
        "repeatability": 4,
        "standardization": 3,
        "demand": 4,
        "outcomes": "notified-body-ready V&V evidence",
        "toolsIP": "SaMD V&V harness"
      },
      {
        "id": "nx_s4",
        "name": "MedTech Engineering Health Check",
        "description": "Rapid assessment of a device program's design-control & submission readiness",
        "delivery": "audit",
        "typicalPrice": "$8k–$15k",
        "effortDays": 6,
        "repeatability": 5,
        "standardization": 4,
        "demand": 4,
        "outcomes": "scored gap analysis + costed plan",
        "toolsIP": "readiness scorecard"
      },
      {
        "id": "nx_s5",
        "name": "Bespoke Engineering Pod",
        "description": "Custom device-engineering pod embedded in the program",
        "delivery": "retainer",
        "typicalPrice": "$30k–$50k/mo",
        "effortDays": 30,
        "repeatability": 2,
        "standardization": 1,
        "demand": 3,
        "outcomes": "varies",
        "toolsIP": ""
      }
    ],
    "service.ladder": [
      {
        "name": "MedTech Engineering Health Check",
        "promise": "Scored readiness + costed plan in a week",
        "price": "$8k"
      },
      {
        "name": "UDI Sprint",
        "promise": "Audit-ready UDI records for one device family in 6 weeks",
        "price": "$25k+"
      },
      {
        "name": "SaMD Assurance Pack",
        "promise": "Notified-body-ready V&V evidence",
        "price": "$40k+"
      },
      {
        "name": "Design-Control Accelerator",
        "promise": "Audit-ready DHF & risk file",
        "price": "$60k+"
      },
      null
    ],
    "db.service.renewals": [
      {
        "id": "nx_r1",
        "accountId": "nx_philips",
        "accountName": "Philips Innovation Campus — Bengaluru",
        "currentOffer": "UDI Sprint (micro-pilot)",
        "renewalDate": "2026-09-15",
        "health": "green",
        "value": "$45k",
        "expansionTarget": "expand to full device-family + Design-Control Accelerator",
        "notes": "Reference sponsor — expansion conversation open."
      }
    ],
    "db.service.proposals": [
      {
        "id": "nx_prop1",
        "name": "Boston Scientific — UDI/DHF remediation proposal"
      }
    ],
    "explorer.taxonomy": [
      {
        "id": "nx_d_dev",
        "name": "MedTech Product Engineering",
        "desc": "Concept-to-commercialization device engineering built to survive design review and audit, not just prototype well.",
        "capabilities": [
          {
            "id": "nx_c_dc",
            "name": "Design Controls & DHF",
            "maturity": "Differentiating",
            "desc": "Design-history-file build-out and design-control process (inputs, outputs, verification, validation, traceability) that stands up to FDA/MDR audit.",
            "features": [
              {
                "id": "nx_f_dhf",
                "name": "Design history file assembly & traceability"
              },
              {
                "id": "nx_f_dv",
                "name": "Design verification & validation planning"
              },
              {
                "id": "nx_f_tm",
                "name": "Requirements → test traceability matrix"
              }
            ],
            "boundaries": {
              "core": [
                "DHF assembly for one device family",
                "Design-control process gap remediation",
                "V&V planning and traceability"
              ],
              "adjacent": [
                "Full QMS build-out (with quality partner)",
                "Clinical trial execution (with CRO partner)"
              ],
              "out": [
                "Acting as legal manufacturer or regulatory sponsor",
                "Guaranteeing regulatory approval"
              ],
              "risks": "Never position as the regulatory decision-maker — the client's regulatory function signs. Anchor scope to one device family, not an open-ended 'quality transformation'."
            }
          },
          {
            "id": "nx_c_rm",
            "name": "Risk Management (ISO 14971)",
            "maturity": "Established",
            "desc": "Risk analysis, FMEA and risk-benefit documentation aligned to ISO 14971 for device and combination products.",
            "features": [
              {
                "id": "nx_f_fmea",
                "name": "Design & process FMEA"
              },
              {
                "id": "nx_f_rmf",
                "name": "Risk management file & report"
              },
              {
                "id": "nx_f_rb",
                "name": "Risk-benefit analysis"
              }
            ]
          }
        ]
      },
      {
        "id": "nx_d_reg",
        "name": "Regulatory & Quality Data Engineering",
        "desc": "The evidence and data layer regulators and notified bodies expect — built and validated, not just advised.",
        "capabilities": [
          {
            "id": "nx_c_udi",
            "name": "UDI / EUDAMED Enablement",
            "maturity": "Differentiating",
            "desc": "Build and validate UDI records for GUDID and EUDAMED, including data model, attribute mapping and submission-ready validation for a device family.",
            "features": [
              {
                "id": "nx_f_udimap",
                "name": "UDI attribute mapping & data model"
              },
              {
                "id": "nx_f_udival",
                "name": "Record validation & submission QA"
              },
              {
                "id": "nx_f_eudamed",
                "name": "EUDAMED / GUDID submission packaging"
              }
            ],
            "boundaries": {
              "core": [
                "UDI record build & validation for one device family",
                "Attribute mapping to GUDID/EUDAMED",
                "Submission-ready QA"
              ],
              "adjacent": [
                "UDI platform selection (with tooling partner)",
                "Label artwork & barcode printing (with packaging partner)"
              ],
              "out": [
                "Owning the regulatory submission of record",
                "Legal responsibility for data accuracy post-handoff"
              ],
              "risks": "Records are validated at handoff; the client's regulatory function owns the submission. Position validation as a starting evidence base, not a compliance guarantee."
            }
          },
          {
            "id": "nx_c_samd",
            "name": "SaMD Verification & Validation",
            "maturity": "Emerging",
            "desc": "IEC 62304-aligned software lifecycle evidence — V&V, traceability and documentation a notified body accepts — for software-as-a-medical-device and AI/ML-enabled devices.",
            "features": [
              {
                "id": "nx_f_62304",
                "name": "IEC 62304 software lifecycle evidence"
              },
              {
                "id": "nx_f_samdvv",
                "name": "SaMD verification & validation execution"
              },
              {
                "id": "nx_f_aiml",
                "name": "AI/ML change-control & performance monitoring"
              }
            ]
          }
        ]
      }
    ],
    "db.explorer.valuemaps": [
      {
        "capabilityId": "nx_c_udi",
        "capabilityName": "UDI / EUDAMED Enablement",
        "tech": "UDI attribute model mapped to GUDID/EUDAMED schemas, with automated validation catching missing/invalid attributes before submission and a QA log per device family.",
        "plain": "We turn a device family's data into complete, validated UDI records ready to submit — instead of a spreadsheet backlog the regulatory team can't get to.",
        "outcome": "Clears the UDI/EUDAMED backlog for a device family in weeks and removes the submission delays and audit findings caused by incomplete records.",
        "cxo": "Your device launches stop waiting on UDI — records are validated, audit-ready and off your regulatory team's critical path.",
        "kpi": "UDI backlog cleared per device family; submission delays avoided; audit findings on UDI records",
        "proof": "Bengaluru MedTech GCC pilot: one connected-device line's UDI records built and validated in 6 weeks, audit-ready at handoff."
      },
      {
        "capabilityId": "nx_c_dc",
        "capabilityName": "Design Controls & DHF",
        "tech": "DHF assembly with a requirements-to-test traceability matrix, design-input/output linkage and V&V planning aligned to FDA design-control and EU MDR expectations.",
        "plain": "We build the design paperwork and traceability a device needs to pass audit — so the engineering team can keep building instead of chasing documents.",
        "outcome": "A device family reaches audit-ready design-control state without pulling senior engineers off the roadmap for months.",
        "cxo": "Your design-control gaps close on a fixed scope and timeline — audit risk down, engineering capacity protected.",
        "kpi": "Design-control gaps closed; audit findings; senior-engineer hours reclaimed",
        "proof": ""
      },
      {
        "capabilityId": "nx_c_samd",
        "capabilityName": "SaMD Verification & Validation",
        "tech": "IEC 62304-aligned software lifecycle evidence with V&V execution, traceability and AI/ML change-control documentation packaged for notified-body review.",
        "plain": "For software that IS a medical device, we produce the testing evidence and paperwork a notified body will accept.",
        "outcome": "SaMD and AI/ML-enabled features clear regulatory review without the rework caused by evidence gaps.",
        "cxo": "Your software features ship because the V&V evidence file is ready when the notified body asks.",
        "kpi": "SaMD review cycle time; V&V evidence gaps at review; rework passes",
        "proof": ""
      }
    ],
    "db.explorer.usecases": [
      {
        "title": "EUDAMED UDI backlog clearance for a connected-device line",
        "industry": "MedTech",
        "function": "Regulatory",
        "problem": "A device family's UDI records are incomplete and stalling EUDAMED submission; the regulatory team has no specialist bandwidth to build and validate them.",
        "capabilityIds": [
          "nx_c_udi"
        ],
        "impact": 5,
        "feasibility": 5,
        "status": "in-market"
      },
      {
        "title": "Design-control remediation ahead of an FDA audit",
        "industry": "MedTech",
        "function": "Quality",
        "problem": "A device family's DHF has traceability gaps flagged in an internal audit; senior engineers can't be pulled off the roadmap to fix it.",
        "capabilityIds": [
          "nx_c_dc",
          "nx_c_rm"
        ],
        "impact": 5,
        "feasibility": 4,
        "status": "validated"
      },
      {
        "title": "SaMD V&V evidence for an AI-in-imaging feature",
        "industry": "MedTech / Imaging",
        "function": "R&D",
        "problem": "An AI/ML imaging feature needs IEC 62304-aligned V&V evidence a notified body will accept, and the team lacks the SaMD lifecycle depth.",
        "capabilityIds": [
          "nx_c_samd"
        ],
        "impact": 5,
        "feasibility": 3,
        "status": "idea"
      },
      {
        "title": "Risk-management file for a digital-surgery module",
        "industry": "MedTech / Robotics",
        "function": "R&D",
        "problem": "A robotics/digital-surgery module needs an ISO 14971 risk file and FMEA before design freeze.",
        "capabilityIds": [
          "nx_c_rm"
        ],
        "impact": 4,
        "feasibility": 4,
        "status": "validated"
      }
    ],
    "db.explorer.comparisons": [
      {
        "name": "UDI backlog clearance — NovintiX pod vs SI vs stay put",
        "context": "A MedTech GCC deciding how to clear a device family's UDI/EUDAMED backlog before a submission deadline.",
        "options": [
          "NovintiX UDI Sprint",
          "Global SI staff-aug",
          "Regulatory boutique (advisory)",
          "Status quo (in-house)"
        ],
        "criteria": [
          {
            "name": "Fit to use case",
            "weight": 5,
            "scores": [
              5,
              3,
              3,
              2
            ],
            "notes": [
              "MedTech-native, UDI-specific",
              "Generalist; needs ramp",
              "Advises, doesn't build",
              "No specialist bandwidth"
            ]
          },
          {
            "name": "Time to value",
            "weight": 5,
            "scores": [
              5,
              3,
              3,
              1
            ],
            "notes": [
              "6-week sprint",
              "Weeks to mobilize + ramp",
              "Report, then still build",
              "Backlog keeps growing"
            ]
          },
          {
            "name": "Total cost (per device family)",
            "weight": 4,
            "scores": [
              5,
              2,
              3,
              3
            ],
            "notes": [
              "Fixed-scope sprint",
              "Rate-card staff-aug adds up",
              "Advisory + rework",
              "Hidden cost = missed deadline"
            ]
          },
          {
            "name": "Audit-readiness of output",
            "weight": 5,
            "scores": [
              5,
              3,
              4,
              2
            ],
            "notes": [
              "Validated records at handoff",
              "Varies by staff",
              "Sound advice, unbuilt",
              "Gaps already flagged"
            ]
          },
          {
            "name": "Ramp / overhead",
            "weight": 3,
            "scores": [
              5,
              2,
              4,
              5
            ],
            "notes": [
              "Slots under existing MSA",
              "New SOW + onboarding",
              "Light engagement",
              "None"
            ]
          },
          {
            "name": "Scales to full portfolio",
            "weight": 3,
            "scores": [
              4,
              5,
              2,
              1
            ],
            "notes": [
              "Family-by-family, provable",
              "Big bench",
              "Limited",
              "n/a"
            ]
          }
        ]
      }
    ]
  }
}