Medical Device Case Study

Technical Environment: Medical devices

Context: 

Our Client is an international manufacturer of Class 2B neuro-life science products.

The challenge was to project manage the transfer of a product and process licenced from a US-based competitor, initially to their UK plant, and ultimately to Ireland. This localisation project involved many risks and high complexity, requiring tight management and control.  Achievement of the scheduled handover date was critical.  Project management expertise was an essential prerequisite, coupled with experience of process transfer, validation and ramp-up in highly-regulated environments.  Project scope included re-layout of the manufacturing site in Ireland to accommodate the new process.

Tecknic’s role: 

  • Project review and development

  • Planning and team communication using, international conferencing, MS Project

  • Management of cross-functional project teams in UK & IRL

  • International coordination of activities between US Multinational Companies

  • Technical support

  • Complex Project Management

Objectives:

  • Set up a new manufacturing site in Ireland

  • Transfer, install, commission and validate new processes

  • Set up new processes in the UK

  • Establish device production by agreed date   

Achievements:

  • New manufacturing plant set up in Ireland with supporting facilities

  • Capable resources to manage and support the manufacturing process

  • Product and processes transferred in part to the UK and IRL

  • Processes validated successfully

  • Supply chain set up and engaged

  • ISO 13485 design management approval & FDA GMP approvals (GAMP4) obtained

  • Managed CE Marking and UL registration for the product

  • On time commencement of production

  • Plant management support in place

 

Technical Environment: Medical and pharmaceutical packaging

Context

Our Client is an international Medical Packaging, Printing and Coating Company.  Operations performance was well below expectations with poor productivity, delivery performance and quality issues.  Significant industrial relations (IR) complications posed an obstacle to change.

Responsibilities

  • Lead a change programme using Lean tools to transform operational performance.

Objectives

  • Provide the technical expertise and leadership needed to establish a leaner system

  • Manage the change process from a reactionary environment to one that was proactive with problem solving using team based techniques and structures

Achievements

  • Internal processes current & future value stream mapped

  • Line balancing implemented to ensure a smooth and synchronous assembly process

  • Kanbans set up to control WIP and finished goods inventories

  • Overall equipment effectiveness (OEE) monitors established

  • Jobs re-designed and new team-based management processes in place

  • 20% increase in throughput achieved