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Engineers: Practical Application of Project Management Principles

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Predictability throughout the commercialization chain is critical to allow manufacturers to speed products to market and gain share within the growing orthopedic industry. As an engineer, your technical and regulatory expertise will be overshadowed if you cannot properly plan and execute a project. One skill every engineer must learn and hone is project management. Start with the steps shared in this session.

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Engineers: Practical Application of Project Management Principles

  1. 1. Chris McDade, PMP Senior Project Manager DePuy Synthes Trauma Engineers: Practical Application of Project Management Skills
  2. 2. • Employee of DePuy Synthes Trauma • Views expressed in this presentation are not those of DePuy Synthes Trauma • All images were publicly sourced and readily available Disclosures
  3. 3. • Scope • Timeline/Schedule • Cost • Resources What is Project Management? • Risk Management • Team Management • Reporting • Planning
  4. 4. • Scope • Resources • Cost • Unexpected Events (Risks) • Prioritization Project Delays Minimize Delays = Predictability
  5. 5. Advantages • Help Patients • Competitive Edge • Planned Revenue • Planned Costs Planning Challenges • New Regulatory Requirements • Change Management Predictability in Medical Device
  6. 6. Phases of a project Charter Phase 1 (Plan) Phase 2 (Design) Phase 3 (V&V) Phase 4 (Launch) Phase 5 (Close) -Business Case -Unmet Need -Project Value -Schedule -Project Scope -Feasibility -Resourcing -Drawings -Prototypes -Inputs -Outputs -Design Risk -Testing -Design Verification -Design Validation -Regulatory Clearance -Final Release -Marketing Materials -Process Validations -Lessons Learned -Metric Assessment Gate C Gate 1 Gate 2 Gate 3 Gate 4 Gate 5
  7. 7. R&D • Technical/Functional Expert • Responsible for Tasks • Estimates for Planning • Accountability Project Teams R&D Quality Regulatory Supply Chain Marketing Operations Core Team Extended Team R&D Sponsor
  8. 8. • Scope & Assumptions • Tasks - Estimates • Learn the processes = DO • Resource Needs • Time Estimates • Experience Project Management – Early Phases Charter Phase 1 (Plan) Phase 2 (Design) Phase 3 (V&V) Phase 4 (Launch) Phase 5 (Close)
  9. 9. Project Estimation Techniques • Analogous • High Level • Top-Down/Bottom up • Detailed • Three-Point • Weighted Project Feasibility Project Planning Charter Phase 1 (Plan)
  10. 10. Three-Point Estimating – Time & Cost Optimistic (O) = 1 weeks Most Likely (ML) = 2 weeks Pessimistic (P) = 4 weeks • Triangular Distribution (O + ML + P)/3 Δ = (1wks+2wks+4wks) / 3 = 2.33wks • Beta Distribution (O + 4ML + P)/6 β = (1wks+[4 x 2wks]+4wks) / 6 = 2.17wks
  11. 11. 80/20 Rule 80% Work 20% Work
  12. 12. Project Management – Active Phases Charter Phase 1 (Plan) Phase 2 (Design) Phase 3 (V&V) Phase 4 (Launch) Phase 5 (Close) • Project Risks • Risk Based Scheduling • Critical Path • Total Slack
  13. 13. • Risk Tools and Techniques • Risk Register • Experience (SMEs) • Lessons Learned • Cadence • Initial Assessment • Changes • Revisit and update throughout project Project Risks Known- Knowns Unknown- Unknowns Unknown- Knowns Known- Unknowns
  14. 14. Risk Register Example Risk Rank Risk Description Prob Impact Total Mitigate/Avoid/ Accept/Transfer Strategy 1 Process Capability Failure Med High High Mitigate Perform test run 2 Engineering resource is removed from project for a short amount of time Low Med Med Avoid Understand critical path, arrange for stand-in resource Mitigate – Reduce prob or impact Avoid – Bypass the Risk Accept – Low prob or impact Transfer – Third Party
  15. 15. Estimation Techniques Risk Based Scheduling 80/20 Rule Risk Based Schedule
  16. 16. Critical Path Critical Path: Any delays will impact the project Total Slack: Time before task ends up on critical path
  17. 17. • Accuracy • Learn and understand processes • Utilize estimation techniques • Account for Risk • Utilize tools to document • Update throughout project • Risk Based Schedule • Manage critical path Summary and Closing Result = PREDICTABILITY
  18. 18. Questions

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