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.

2. Chris McDade, PMP
Senior Project Manager
DePuy Synthes Trauma
Engineers: Practical
Application of Project
Management Skills

3. • 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

4. • Scope
• Timeline/Schedule
• Cost
• Resources
What is Project Management?
• Risk Management
• Team Management
• Reporting
• Planning

5. • Scope
• Resources
• Cost
• Unexpected Events (Risks)
• Prioritization
Project Delays
Minimize Delays = Predictability

6. Advantages
• Help Patients
• Competitive Edge
• Planned Revenue
• Planned Costs
Planning Challenges
• New Regulatory Requirements
• Change Management
Predictability in Medical Device

7. 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

8. 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

9. • 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)

10. Project Estimation Techniques
• Analogous
• High Level
• Top-Down/Bottom up
• Detailed
• Three-Point
• Weighted
Project Feasibility
Project Planning
Charter
Phase 1
(Plan)

11. 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

12. 80/20 Rule
80% Work
20% Work

13. 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

14. • 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

15. 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

16. Estimation Techniques
Risk Based Scheduling
80/20 Rule
Risk Based
Schedule

17. Critical Path
Critical Path:
Any delays will
impact the project
Total Slack:
Time before task
ends up on
critical path

18. • 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

19. Questions