FIND YOUR CONSULTANT
JOIN OUR COMMUNITY
FIND YOUR CONSULTANT
JOIN OUR COMMUNITY

Industries > 

Life Sciences > Medical Devices & Diagnostics Practice (Capital Equipment & Disposables/IVD)

Medical Devices & Diagnostics Practice (Capital Equipment & Disposables/IVD)

Umbrex connects companies in medical devices & diagnostics (capital equipment & disposables/IVD) to independent consultants with deep experience in the industry.

Over 90% of our Medical Devices & Diagnostics (Capital Equipment & Disposables/IVD) Practice consultants are alums of McKinsey, Bain, or BCG.

Finding the right consultant should be this easy.

1

Tell us about your project

2

Interview candidates

(We’ll provide bios within 48 hours on average)

3

Select your consultant and start work!

Find a consultant in our Medical Devices & Diagnostics (Capital Equipment & Disposables/IVD) Practice

Prefer email? Write to [email protected]

Client Segments Umbrex Serves

  • Imaging and patient monitoring OEMs: Manufacturers of radiology, ultrasound, patient monitoring, and critical-care capital equipment; accelerate innovation, connectivity, installed-base monetization, service, and value-based contracting (excluding dental imaging).
  • Surgical and interventional device manufacturers: Firms producing implants, instruments, endoscopy, and surgical robotics across ortho, cardio, neuro; optimize evidence, surgeon adoption, pricing, ASC strategy, and global launch excellence.
  • Consumables and infection prevention manufacturers: Producers of single-use disposables, infusion and dialysis sets, wound care, PPE, and sterilization; improve portfolio value, manufacturing yields, supply resilience, GPO contracting, and channel economics.
  • Clinical diagnostics (IVD) companies: Clinical IVD instrument and reagent manufacturers serving hospitals and reference labs; strengthen evidence, menu expansion, automation, LIS integration, POC deployment (excluding research-only life-science tools).
  • Medtech contract manufacturers and component suppliers: Contract manufacturers and specialty suppliers providing machining, molding, electronics, coatings, sterilization, and packaging to device OEMs; scale quality systems, NPI, cost, capacity, and customer diversification.
  • Imaging and patient monitoring OEMs: Manufacturers of radiology, ultrasound, patient monitoring, and critical-care capital equipment; accelerate innovation, connectivity, installed-base monetization, service, and value-based contracting (excluding dental imaging).
  • Surgical and interventional device manufacturers: Firms producing implants, instruments, endoscopy, and surgical robotics across ortho, cardio, neuro; optimize evidence, surgeon adoption, pricing, ASC strategy, and global launch excellence.
  • Consumables and infection prevention manufacturers: Producers of single-use disposables, infusion and dialysis sets, wound care, PPE, and sterilization; improve portfolio value, manufacturing yields, supply resilience, GPO contracting, and channel economics.
  • Clinical diagnostics (IVD) companies: Clinical IVD instrument and reagent manufacturers serving hospitals and reference labs; strengthen evidence, menu expansion, automation, LIS integration, POC deployment (excluding research-only life-science tools).
  • Medtech contract manufacturers and component suppliers: Contract manufacturers and specialty suppliers providing machining, molding, electronics, coatings, sterilization, and packaging to device OEMs; scale quality systems, NPI, cost, capacity, and customer diversification.

Selected Capabilities of our Medical Devices & Diagnostics (Capital Equipment & Disposables/IVD) Practice

Operations

  • Manufacturing Excellence And OEE Uplift: Deploy lean, standard work, SMED, and TPM across device and IVD lines; raise OEE, yield, and throughput; cut scrap, labor hours, and cost of goods.
  • New Product Introduction And Process Validation: Industrialize designs with DFM/DFA and PFMEA; plan IQ/OQ/PQ and PPQ; accelerate tech transfer and ramp-to-volume with right-first-time yields and stable takt.
  • Sterilization, Cleanroom, And Contamination Control: Optimize EtO, gamma, and e-beam cycles, load density, and aeration; tighten cleanroom procedures and environmental monitoring; reduce bioburden, rework, rejects, and sterilization turnaround time.
  • IVD Reagent Manufacturing Optimization: Optimize formulation, mixing, filtration, filling, lyophilization, and packaging; minimize potency drift and QC holds; increase lot-release velocity, yield, and batch reliability.
  • Test Strategy And End-Of-Line Automation: Redesign functional test, calibration, and burn-in; implement in-line test automation and fixtures; reduce cycle time, rework, RMAs, and warranty cost for capital equipment manufacturing.

Organization

  • Operating Model And Organizational Design: Redesign global product line and regional matrix with interfaces across research and development, quality, regulatory, and operations; set spans and layers; accelerate decisions and accountability.
  • Governance And Decision Rights Redesign: Establish design control and stage-gate governance, decision rights, and escalation across research and development, clinical, quality, and regulatory; cut rework, cycle time, and launch risk.
  • Global Business Services And Shared Services: Stand up shared services for finance, procurement, human resources, master data, and analytics; define service catalogs and service level agreements; reduce cost-to-serve, errors, and time-to-close.
  • Talent Strategy And Capability Building: Build talent strategy for systems engineering, software, quality, regulatory, manufacturing; create academies, career paths, and workforce plans; improve retention, capability depth, and leadership bench.
  • Performance Management And Incentive Architecture: Design key performance indicator (KPI) hierarchy, dashboards, and incentives aligned to quality, compliance, on-time launch, cost, and service; cascade goals; increase accountability and cross-functional performance.

Pricing

  • Price Architecture And Monetization Model Design: Define price architecture for equipment, disposables, and IVD; design reagent rental, pay‑per‑use, subscriptions, and service bundles; maximize margin, recurring revenue, and customer lifetime value.
  • Global Price List And Corridor Management: Set regional list prices, corridors, and channel margins; incorporate FX and reference benchmarks; govern price harmonization; prevent gray‑market arbitrage; protect price integrity and brand.
  • Tender, GPO, And IDN Pricing Optimization: Design tender and GPO pricing ladders, rebates, and walk‑away points; simulate award scenarios; improve win rate, compliance, and margin across hospital IDNs and public procurement.
  • Deal Desk And CPQ Pricing Governance: Stand up deal desk with approval matrices, floor prices, and value calculators in CPQ; reduce cycle time, discount variance, and margin leakage on complex deals.
  • Price Realization And Waterfall Improvement: Build price waterfall to pocket margin; fix leakage from discounts, free goods, installation, freight, warranty, and training; raise net price, profitability, and control.

Transformation

  • Enterprise Performance Transformation And EBITDA Uplift: Lead enterprise-wide transformation for medical devices and IVD; prioritize value levers and sprint execution; deliver EBITDA uplift, cash acceleration, and durable margin expansion.
  • Transformation Office And Value Capture: Stand up transformation office, benefits tracking, OKRs, risk management, and cadence; enforce accountability and course corrections; ensure synergy realization and on-time delivery.
  • Zero Based Cost And SG&A Reset: Deploy zero-based budgeting and design-to-value; restructure SG&A, indirect spend, and overhead; capture structural cost reductions without compromising quality, compliance, or growth.
  • Post Merger Integration And Carve Out Execution: Execute integrations and carve-outs across capital equipment, disposables, and IVD; harmonize processes and systems; deliver synergies while protecting supply continuity, customers, and compliance.
  • Working Capital And Cash Excellence: Run cash acceleration sprints across order-to-cash, procure-to-pay, and forecast-to-fulfill; reduce DSO and inventory days; free cash and strengthen covenant headroom.

Compliance

  • Healthcare Compliance Program Design And Governance: Design device and IVD compliance programs aligned to AdvaMed and MedTech Europe; govern HCP interactions, Anti‑Kickback Statute compliance, Open Payments; improve monitoring and audit readiness.
  • Third-Party Risk And Anti Bribery Compliance: Implement third‑party risk management for distributors and agents; conduct due diligence, contract clauses, and monitoring under FCPA and UK Bribery Act; reduce corruption, sanctions exposure.
  • Tender And Antitrust Compliance: Build tender governance, competition law guardrails, and information‑sharing protocols; run bid review committees and training; prevent collusion risk and ensure compliant public procurement participation globally.
  • Data Privacy And Connected Device Compliance: Design privacy and cybersecurity compliance for connected devices and diagnostics; align to GDPR and HIPAA; enable consent, data minimization, DPIAs, incident response, and vendor oversight.
  • Global Trade And Export Compliance: Stand up import and export controls program; manage ECCN and HTS classification, restricted party screening, and licensing under EAR/ITAR; reduce delays, penalties, and supply interruptions.

Program & Portfolio Management

  • Portfolio PMO And Stage-Gate Governance: Establish design-control stage-gate PMO across capital equipment, disposables, IVD; standardize charters, tollgates, and KPIs; increase on-time submissions, builds, and launches.
  • Resource And Capacity Portfolio Planning: Model constrained engineering, test labs, quality, regulatory, and suppliers; scenario plan prioritization; maximize throughput, cycle time, and portfolio on-time-in-full.
  • Launch Readiness And Cutover Management: Orchestrate integrated launch plans across manufacturing, quality, regulatory, supply, marketing, service; run rehearsals and war rooms; hit validation, ship, and revenue ramp milestones.
  • OEM And Alliance Program Management: Manage original equipment manufacturer partners, contract manufacturers, and platform alliances; govern milestones, tech transfer, process performance qualification (PPQ); reduce delays, deviations, and budget overruns.
  • Portfolio Reporting, Risk, And Benefits Realization: Build dashboards, critical path, dependency maps, earned value, and risk burndown; tie to business cases; increase transparency, predictability, and benefits realization.

Information Technology

  • ERP Transformation And S/4HANA Template: Design and roll out SAP S/4HANA blueprint for medical devices and IVD—manufacturing, serials, UDI, warranty, service, revenue recognition; improve close speed, traceability, and control.
  • PLM, ALM, And Digital Thread Enablement: Implement PLM and application lifecycle management integrating CAD, requirements, BOM, software, DHF, and ERP; enable change control and digital thread; reduce cycle time and rework.
  • MES And eDHR Deployment: Select and implement MES with electronic Device History Record; digitize work instructions, travelers, and genealogy; increase right‑first‑time, traceability, and cut release cycle time.
  • Connected Device IoT Platform Enablement: Deploy IoT platform for equipment and analyzers; collect telemetry; enable remote diagnostics, OTA updates, predictive maintenance; integrate FSM/CRM; reduce downtime and RMAs.
  • Enterprise And Product Cybersecurity Architecture: Design enterprise and product cybersecurity—Zero Trust, secure SDLC, SBOM, vulnerability management; meet FDA premarket/postmarket guidance; protect patient data, cloud connectivity, and OT.

Regulatory Affairs & Certifications

  • Regulatory Strategy And Classification Pathway: Determine classification and pathway across FDA 510(k), De Novo, PMA, EU MDR/IVDR, UKCA; align indications, claims, and evidence; compress review timelines.
  • Technical Documentation And Submission Development: Author FDA 510(k)/De Novo/PMA and EU MDR/IVDR technical documentation; map GSPR/SPR; compile risk, sterilization, biocompatibility, software, cybersecurity; reduce deficiencies and questions.
  • Clinical, Analytical, And Performance Evaluation: Build CER/PER, PMCF/PEP, analytical validity and clinical performance plans; design CLIA waiver studies; justify equivalence; meet IVDR scrutiny and FDA expectations.
  • UDI, Labeling, And EUDAMED/GUDID Enablement: Design global UDI, eIFU, and labeling; execute GUDID/EUDAMED submissions, translations, country requirements; enable traceability, recalls, and faster registrations.
  • Certifications, Notified Body Readiness, And Global Registrations: Prepare ISO 13485 and MDSAP audits; manage CE marking with notified bodies; coordinate Health Canada, NMPA, PMDA, ANVISA, TGA registrations; accelerate market access.

Quality Management Systems

  • Quality System Design And Harmonization: Design and harmonize QMS to ISO 13485 and 21 CFR 820 Quality Management System Regulation; standardize procedures; cut deviations, cycle time, audit findings.
  • Design Control And Risk Management Excellence: Strengthen design control, Design History File and Device Master Record traceability, ISO 14971 risk management, usability, and verification validation governance; reduce gaps, complaints, and time-to-approval.
  • Corrective And Preventive Action And Change Control Optimization: Redesign triage, root cause analysis, effectiveness checks, and change control; deploy risk-based workflows; eliminate backlog, recurrence, and cycle time.
  • Supplier Quality And Corrective Action Governance: Establish quality agreements, risk-based audits, incoming controls, and supplier corrective action requests; improve incoming quality, first article approval, on-time-in-full (OTIF), and compliance.
  • Complaint Handling And Vigilance Process: Build complaint intake, investigation, FDA Medical Device Reporting and EU vigilance controls, trending, feedback loops; accelerate closure, reduce errors, enhance signal detection and recall readiness.

Reimbursement & Market Access

  • Reimbursement Strategy And Evidence Roadmap: Define end‑to‑end reimbursement strategy for devices and diagnostics; align clinical endpoints and economic evidence; secure coding, coverage, and payment; accelerate adoption and revenue.
  • Coding And Payment Pathway Development: Secure coding and payment pathways: CPT and HCPCS applications, DRG and APC mapping, CLFS and OPPS rate strategy; improve payer processing and provider economics.
  • Coverage Policy And Payer Engagement: Shape national and local coverage determinations, develop payer value dossiers, and run medical policy engagements; reduce prior authorization barriers and expand coverage criteria.
  • Health Technology Assessment And Value Dossier Development: Build Health Technology Assessment submissions and value dossiers for NICE, G‑BA, CADTH; deliver evidence syntheses and stakeholder engagement; secure favorable recommendations and access.
  • Provider Value Analysis And Access Enablement: Win hospital value analysis approvals and formularies; craft clinical, economic, and operational cases; standardize value analysis committee toolkits; accelerate site adoption and contracting readiness.

Connect with the right consultant

Umbrex rapidly connects you with independent professionals who combine top‑tier consulting experience at firms such as McKinsey, Bain, Boston Consulting Group with hands‑on roles.

Find a consultant in our Medical Devices & Diagnostics (Capital Equipment & Disposables/IVD) Practice

Prefer email? Write to [email protected]