KESSCO Mission

KESSCO provides executive management and consulting services for start-up, early and mid-stage medical technology companies.  We work closely with our customers to develop efficient and effective business strategies, processes, and implementations to optimize critical business requirements.  We work with the highest integrity in providing on-time, high quality, high value, and cost effective services that earn the trust and respect of our clients and partners. 

When should you consider using KESSCO?

When your company needs:

    • Experienced and focused management consulting to grow your business to the ‘next level’
    • Excellent understanding of key business and process tradeoffs necessary to meet business goals
    • Identification  and implementation of new or improved business strategies in operations, supply chain, and new product introduction to achieve time to market, process improvements, cost reduction, and/or improved quality goals
    • Development, planning, and achievement of key milestone goals
    • Understanding key technologies including electro/mechanical, robotics, software, x-ray, imaging, and patient monitoring
    • Knowledge of key processes including, vendor and contract manufacturing, lean, ERP/PLM, and medical and quality regulations 

Key Values Provided

Strategic Supply Chain and Operations Development and Implementation

  • Worldwide Supply Chain Strategy and Development

    • Supplier management, monitoring and rationalization
    • Supplier qualification and risk analysis
    • Product cost negotiations
    • Global outsourcing
    • Distribution and logistics
    • Demand/supply matching
    • Inventory Strategy and Controls
    • Component life cycle management

  • Operations Strategies

    • Manufacturing
    • Manufacturing line set up and optimization
    • Resource planning
    • Process development
    • Contract Manufacturing
      • Make/Buy analysis
    •  Lean Practices
    • Visual Manufacturing
    • Service and Repairs

  • Start-up, early and mid-stage companies
  • Due Diligence

Experience in Medical Devices, Processes, Technologies, Regulations, Tools

  • Program Management

  • Business Systems including ERP, PLM, CAPA, NCMR, etc.

  • Product and Manufacturing Engineering

    • New Product Introduction
    • Sustaining Engineering
    • Life cycle management
    • Exit strategies

  • Medical Device Regulations/Quality Systems

    • ISO 13485 – Quality systems for medical device manufacturer
    • FDA product regulation
    • cGMP – FDA Quality System Regulation
    • International testing and compliance requirements (e.g., IEC 60601…)
    • Product and Process Verification/Validation
    • RoHS and WEEE

  • Technology expertise in X-ray, Patient Monitoring, Robotics, Electro/Mechanical Devices, and Software