Engineers Ireland & Cora The Role of Project Management in - - PowerPoint PPT Presentation

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Engineers Ireland & Cora The Role of Project Management in - - PowerPoint PPT Presentation

Engineers Ireland & Cora The Role of Project Management in Medical Device Manufacturing John Dolan 25 th Oct 2018 1 Agenda Company Context Structure & Functions Common Pitfalls Journey Project Tools & Systems Challenges &


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Engineers Ireland & Cora

The Role of Project Management in Medical Device Manufacturing

John Dolan 25th Oct 2018

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Agenda

Company Context Structure & Functions Journey Common Pitfalls Project Tools & Systems Challenges & Strategies

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Boston Scientific 24,000

people

13,000

products

$7.2 bn

revenue

40+

Countries

#1 or #2

in 75% of our markets

One of the World’s Largest Medical Device Companies

HQ: Marlborough, Boston

= countries where we operate Key:

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4 Interventional Cardiology Cardiac Rhythm Management Urology and Women’s Health Neuromodulation Endoscopy Peripheral Intervention

Core Businesses

Key Galway Products

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Boston Scientific Galway

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Boston Scientific Galway is the company’s largest facility

  • Established 1994
  • 43 products supporting $1.7bn revenue
  • 2nd largest manufacturer in Ireland
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Galway Campus

R&D Manufacturing Operations Process Development Field Investigation Centre Global Data Centre Laboratories Regulatory Affairs Customer Technology Centre Europe Sales and Marketing

Medical Device Facility

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  • Multiple project types

 Challenge to Align

  • 100s of products

 High Complexity

  • Alongside Production

 Weak Matrix Structure

Product Lifecycle & Projects

R&D / Design Equipment Facilities CAPA Clinical Systems VIP DMAIC Process Development Acquisition Software

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  • Multiple project types

 Challenge to Align

  • 100s of products

 High Complexity

  • Alongside Production

 Weak Matrix Structure

Product Lifecycle & Projects

“Weak Matrix” Structure

Director Functional Manager Staff Staff Staff Functional Manager Staff Staff Staff Functional Manager Staff Staff Staff Project Manager

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Beware….. …affect many organisations

Scope creep Unapproved Changes Resource constraints Changing priorities Optimistic timelines Learn from the Past Too Little Planning Communication Budgets Align with Strategy

Common Pitfalls

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Journey

  • Site team focused on project management competencies

Benchmark

What are others doing in indusctry

Develop Tools

Design/develop tools to support the system

Improve

Review and improve tools & system

Training & Support

Train and support people to the new way of doing things

Develop System

Develop a process and system to run business

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Standard Process

  • Standardise Project Lifecycle
  • PMBOK Process Groups / Phases
  • Suits diversity of projects
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System Process

Process System

0. Concept 1. Initiate 2. Plan 3. Execute 4. Monitor & Control 5. Close

Tools Behaviours Measures Training Owners Purpose

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Tools

  • Consider tools which drive key behaviours

Use of tools  Effective Archive for next projects  Efficient & Improving Gantt Budget Lessons Learned Risk Register Communications Plan Charter Phase Reviews Decision Logs

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Tools

  • Single system for all tools
  • Visual & measurable
  • Archive for lessons learned

Cost Service (Supply) Quality Safety

Priorities:

Regulatory? Speed to Market? Strategic? Corporate? Factors: Timing? Alignment?

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Challenges

Flexibility Buy-In Priorities

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Summary

  • Balance structure and flexibility
  • Commit team & time to system
  • Choose tools which drive key behaviours