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 & Strategies 2
Boston Scientific One of the World’s Largest Medical Device Companies HQ: Marlborough, Boston # 1 or # 2 24,000 13,000 $7.2 bn 40+ in 75% of our people products revenue Countries markets Key: = countries where we operate 3
Core Businesses Neuromodulation Interventional Cardiology Cardiac Rhythm Key Galway Products Management Endoscopy Urology and Peripheral Women’s Health Intervention 4
Boston Scientific Galway Boston Scientific Galway is the company’s largest facility • Established 1994 • 43 products supporting $1.7bn revenue • 2 nd largest manufacturer in Ireland 5 5
Medical Device Facility Manufacturing Process Operations R&D Development Field Europe Investigation Sales and Centre Marketing Galway Campus Customer Laboratories Technology Centre Regulatory Global Affairs Data Centre 6
Product Lifecycle & Projects Process Facilities Development R&D / Design Equipment Software Systems VIP DMAIC Acquisition Clinical CAPA • Multiple project types Challenge to Align • 100s of products High Complexity • Alongside Production Weak Matrix Structure 7
Product Lifecycle & Projects Director Functional Functional Functional Manager Manager Manager “Weak Matrix” Structure Staff Staff Staff Staff Staff Staff Project Staff Staff Staff Manager • Multiple project types Challenge to Align • 100s of products High Complexity • Alongside Production Weak Matrix Structure 8
Common Pitfalls Beware….. Unapproved Scope creep Resource Changing Optimistic Changes constraints priorities timelines Learn from Too Little Communication Budgets Align with the Past Planning Strategy …affect many organisations 9
Journey • Site team focused on project management competencies Benchmark What are others doing in indusctry Develop System Develop a process and system to run business Develop Tools Design/develop tools to support the system Training & Support Train and support people to the new way of doing things Improve Review and improve tools & system 10
Standard Process • Standardise Project Lifecycle • PMBOK Process Groups / Phases • Suits diversity of projects 11
Process System System Owners Training Purpose Process 4. 0. 1. 2. 3. 5. Monitor & Concept Initiate Plan Execute Close Control Tools Measures Behaviours 12
Tools • Consider tools which drive key behaviours Charter Budget Gantt Lessons Learned Risk Register Communications Plan Phase Reviews Decision Logs Use of tools Effective Archive for next projects Efficient & Improving 13
Tools • Single system for all tools Priorities: • Visual & measurable Safety • Archive for lessons learned Quality Service (Supply) Cost Factors: Regulatory? Strategic? Corporate? Speed to Market? Timing? Alignment? 14
Challenges Flexibility Buy-In Priorities 15
Summary • Balance structure and flexibility • Commit team & time to system • Choose tools which drive key behaviours 16
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