Medical Devices: SEM Essentials - sdincose.org...Medical Devices: SEM Essentials Where Financial Performance Meets Quality . Presented at the 19th Annual INCOSE Region II Fall Mini-Conference

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.

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.

© 2014 – All Rights Reserved: The California Institute for Performance Management

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


Defining Performance (3) A word On Overall Organizational

Performance ◦ The is more than Financial Metrics ◦ Social Responsibility; Sustainability…


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.


Performance Metrics for R&D Number of proprietary products versus

competitors.

Time to develop new products.

Affordability on the Marketplace.


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.


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


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



Organizational Performance

Portfolio Performance

Program Performance

1 2 …10

… 2 1 3 4 5 6 7

Project Performance

A Project Management Perspective

Performance Baseline

COST

TIME

QUALITY

SCOPE


Performance Baseline

NOVELTY

AFFORDABILITY

ACCESSIBILITY

RELIABILITY

R&D Perspective

Marketplace Perspective

Performance Baseline Uncertainty


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.

Performance Baseline Uncertainty


By Phase

Detailed Design &

Production

Preliminary Design & Validation

Concept Feasibility

Increasing Degree of Uncertainty

Developmental Direction

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


PM - SEM

WBS Iterative Process

PMI Global Standards

ANSI/EIA-632; ISO-15288; IEEE-1220 ISO 13485 Standards


Political Pyramid ≠ Leadership


Program Manager

Preferred Engineer

Engineer

SEM

The Glory of Technology Advancement

The Face of Leadership


Project Leader/Mentor

Conclusion


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

Medical Devices: SEM Essentials - sdincose.org...Medical Devices: SEM Essentials Where Financial Performance Meets Quality . Presented at the 19th Annual INCOSE Region II Fall Mini-Conference

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