Program Overview
This program is tailored for the medical devices industry, where supply-chain complexity, global regulatory pressures, and patient-safety requirements demand transformation beyond efficiency alone. Delivered by an expert with years of experience in MedTech supply chains and transformation programs, the course blends conceptual frameworks, regulatory insights, case studies, and simulations to help leaders manage compliance-driven supply-chain readiness, risk resilience, digital enablement, and ESG expectations. Participants will gain tools to benchmark their supply-chain maturity, anticipate risks from EU MDR/IVDR, FDA QMSR, UDI and traceability mandates, and align KPIs such as OTIF, supplier-quality scores, recall-readiness, and carbon footprint with transformation roadmaps.
Features
- Identify readiness gaps in People, Process, Technology, Compliance, and Partner ecosystems.
- Map business-transformation drivers (compliance, digitalization, sustainability, resilience) to MedTech supply-chain levers.
- Apply regulatory-aligned frameworks (MDSAP, EU MDR/IVDR traceability, FDA UDI/QMSR) to strengthen supply-chain maturity.
- Build a MedTech-specific transformation action plan balancing regulatory compliance, resilience, and business growth.
Target audiences
- Supply Chain & OpLogistics Teams
- Procurement Teams
- Planning and Business Excellence Teams
- Quality & Regulatory Affairs Teams
- Manufacturing and Operations Professionals
Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
- Transformation Imperatives in Med-Device Supply Chains4
- 1.1Drivers of Business Transformation in MedTech: global regulatory tightening (EU-MDR/IVDR, FDA QMSR), cost-to-serve pressures, post-COVID resilience needs, ESG & traceability demands.
- 1.2Supply-Chain as a transformation lever: enabling quality-compliant speed-to-market and cost agility
- 1.3Core frameworks & maturity models: SCOR-SCM, 5 Ps of Transformation (People-Process-Platform-Performance-Partners), twin-transition (Digital + Sustainable).
- 1.4Key Med-Device Terms: UDI, e-IFU, PMS, CAPA, cold-chain compliance, lot-traceability, GxP logistics
- Readiness Gaps & Emerging Risks4
- 2.1Macro-trends: near-shoring vs global sourcing, supplier-qualification hurdles under MDR/IVDR, digital-twin visibility, cyber-secure device distribution.
- 2.2Transformation archetypes: regulatory-driven, cost-take-out, growth-enablement, sustainability-mandated
- 2.3Risk & readiness assessment: People / Process / Tech / Compliance / Partners
- 2.4Change-management challenges: QA-Ops alignment, data-integrity in ERP/eQMS, multi-jurisdiction customs & import/export compliance.
- Lessons from the Med-Device Field5
- 3.1Case 1 – EU-MDR transition: redesign of supplier network & labelling to sustain CE-mark
- 3.2Case 2 – US-FDA QMSR alignment: harmonising global sites’ QMS & SC metrics
- 3.3Case 3 – Cold-chain-sensitive diagnostics: balancing GDP/GMP compliance with cost-to-market
- 3.4Case 4 – Digital-twin rollout: predictive risk-response for component shortages during a recall
- 3.5KPIs that matter – OTIF in regulated shipments, lot-trace compliance, NC/CAPA cycle-time, lead-time compression
- Readiness in Action4
- 4.1Heat-Map Workshop: score own SC maturity & compliance risk exposure
- 4.2Scenario Simulation: respond to disruption (supplier non-conformance / sudden reg-change) using resilience levers
- 4.3Stakeholder-Mapping Game: identify QA/RA, Ops, Supplier, and Commercial champions & blockers
- 4.4Linking supply-chain readiness with transformation success & regulatory continuity
- Wrap-Up & Key Take-Aways3
Instructor
