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Medical Devices: SEM Essentials
Where Financial Performance Meets Quality Presented at the 19th Annual INCOSE Region II Fall Mini-Conference November 1, 2014
Yves Theriault, PhD, PMP President The California Institute for Performance Management
© 2014 – All Rights Reserved: The California Institute for Performance Management. Permission granted to INCOSE to publish and use.
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Defining Performance “The way someone or something functions” ◦ “The pilot thought that the plane performed well” ◦ The American Heritage Dictionary of the English Language, 4th Edition, 2009, Houghton, Mifflin,
Harcourt.
Performance must be measured.
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Defining Performance (2) Performance is a quantitative attribute,
associated with a metric or set of metrics taken in their appropriate context, which determine the relative level of success of a process, system, individual or organization. ◦ Yves Theriault, 2014
© 2014 – All Rights Reserved: The California Institute for Performance Management
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Defining Performance (3) A word On Overall Organizational
Performance ◦ The is more than Financial Metrics ◦ Social Responsibility; Sustainability…
© 2014 – All Rights Reserved: The California Institute for Performance Management
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Performance Metrics for R&D Cost of Development per commercial Medical
Devices. ◦ Is not a great metric. ◦ Some devices may cost more to develop but bring
higher revenues.
The Ratio of Total Revenues over a defined period of time to the R&D cost of the commercial devices developed during same period. ◦ Is a better metric.
© 2014 – All Rights Reserved: The California Institute for Performance Management
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Performance Metrics for R&D Number of proprietary products versus
competitors.
Time to develop new products.
Affordability on the Marketplace.
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About Performance Performance must be planned for. Performance must be monitored and measured. Performance enhancement is realized via lessons
learned and the consequent taking of appropriate actions.
Strategic implementation constitutes the cornerstone of any R&D-based organization.
To ensure performance in strategic implementation, a SYSTEM must be put in place
The Integration of PMI and SEM Global Standards Constitute a Framework for that System.
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Multidirectional Alignment Multidirectional Alignment is the
ensemble of processes enabling real-time triggering of responses from strategically deployed core competencies at all levels of an organization’s multi-functional infrastructure in order to ensure the deployment, execution, focused compliance, re-assessment, modification, improvement and re-deployment of its strategic programs on an ongoing basis.
Yves Theriault, 2008
© 2014 – All Rights Reserved: The California Institute for Performance Management
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SEM and MDA
SEM is MDA applied in the context of integrated system engineering team and total quality management.
Optimization of Total Life Cycle Value Management
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© 2014 – All Rights Reserved: The California Institute for Performance Management
Organizational Performance
Portfolio Performance
Program Performance
1 2 …10
… 2 1 3 4 5 6 7
Project Performance
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A Project Management Perspective
Performance Baseline
COST
TIME
QUALITY
SCOPE
© 2014 – All Rights Reserved: The California Institute for Performance Management
Performance Baseline
NOVELTY
AFFORDABILITY
ACCESSIBILITY
RELIABILITY
R&D Perspective
Marketplace Perspective
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Performance Baseline Uncertainty
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The ability to establish a reliable performance baseline and conform to it is directly proportional to the degree of control that the performing organization has on the project development.
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Performance Baseline Uncertainty
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By Phase
Detailed Design &
Production
Preliminary Design & Validation
Concept Feasibility
Increasing Degree of Uncertainty
Developmental Direction
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P M E C
P M E C
P M E C
P M E C
Portfolio Management
PMO
PROJECT MANAGEMENT
Training
Historical Database
Strategic Program Creation
Standardized Templates &
Guidelines Performance Assessments &
Balanced ScoreCards
PERFORMANCE MANAGEMENT SYSTEM = PMO
IT Infrastructure
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PM - SEM
WBS Iterative Process
PMI Global Standards
ANSI/EIA-632; ISO-15288; IEEE-1220 ISO 13485 Standards
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Political Pyramid ≠ Leadership
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Program Manager
Preferred Engineer
Engineer
SEM
The Glory of Technology Advancement
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The Face of Leadership
© 2014 – All Rights Reserved: The California Institute for Performance Management
Project Leader/Mentor
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Conclusion
© 2014 – All Rights Reserved: The California Institute for Performance Management
SEM is essential in achieving developmental and quality performance.
The Integration of PM and SEM Global Standards is essential to optimize overall organizational performance.
Program Manager and System Engineering Manager must work in harmony.
Leadership is a must, not an option. All of the above are essential to
affordable healthcare.
Medical Devices: SEM EssentialsDefining PerformanceDefining Performance (2)Defining Performance (3)Performance Metrics for R&DPerformance Metrics for R&DAbout PerformanceMultidirectional AlignmentSEM and MDASlide Number 10A Project Management PerspectivePerformance Baseline UncertaintyPerformance Baseline UncertaintySlide Number 14PM - SEMPolitical Pyramid ≠ LeadershipThe Face of LeadershipConclusion