Mangelnde DMR-Transparenz führt zu falschen Sourcing- und Kapazitätsentscheidungen
Definition
Executives and procurement teams rely on accurate, current DMR data to make supply chain and capital investment decisions. When DMR information is fragmented (component specs in engineering spreadsheets, cost data in legacy ERP, sterilization requirements in paper files), decision-makers often choose suboptimal suppliers or underestimate equipment capex. Example: A production manager decides to source a critical sub-assembly from Supplier A based on quoted lead time, unaware that the DMR mandates Supplier B's version for biocompatibility reasons. Order is placed, shipped, and discovered non-compliant at receiving—wasting €20,000 and delaying production 6 weeks. Similar errors cascade across sourcing, equipment selection, and production planning.
Key Findings
- Financial Impact: Supplier errors (non-compliant orders, rework): €10,000–€40,000 per incident; equipment over-investment (buying redundant sterilization systems): €50,000–€200,000; production delays due to capacity miscalculation: 2–4 weeks lost revenue = €50,000–€150,000 per product launch; estimated 2–3 major decision errors annually per manufacturer = €200,000–€800,000 annual exposure
- Frequency: Supply chain errors: 2–3 per year; capacity planning errors: 1 per major product launch (1–2 annually); equipment investment mistakes: every 3–5 years
- Root Cause: Siloed DMR data (no single source of truth); manual data entry errors in supplier specifications; outdated equipment requirements not flagged; no real-time cost analytics from DMR; poor change management visibility (product redesigns not reflected in sourcing criteria)
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Medical Equipment Manufacturing.
Affected Stakeholders
Procurement / Supply Chain, Production Planning, Finance / Cost Accounting, Regulatory Affairs, Executive Management
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Financial Impact
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Current Workarounds
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Methodology & Sources
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Related Business Risks
Manuelle DMR-Verwaltung erzeugt Produktionsengpässe und Lieferverzögerungen
Kapazitätsverluste durch HTA-Bewertungsengpässe
Bußgelder für verspätete Lieferketten-Meldungen
Kosten durch mangelhafte Eingangsinspektion und Materialzertifizierung
Bürokratische Mehrkosten durch MPBetreibV-Anpassungen
Lieferkettenstörungen durch unzureichende Materialzertifizierung
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