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First Principles
Reasoning from fundamental truths toward the fundamental objectives of safety and effectiveness.
MPSEI is organized around one framework: reasoning from fundamental truths and cause-and-effect relationships toward justified confidence, sound decisions, and improved patient outcomes.
The pathway begins with First Principles, moves through Safety & Effectiveness, Justified Confidence, and Decisions, and ends with Patient Outcomes.
The five-part MPSEI framework chain.
First Principles
Reasoning from fundamental truths toward the fundamental objectives of safety and effectiveness.
Confidence
A justified level of belief that a medical product will achieve its intended benefits while maintaining acceptable levels of risk throughout its lifecycle.
Proficiency
The capability of organizations to consistently apply sound principles, practices, evidence, and judgment to make effective safety and effectiveness decisions and continuously improve outcomes.
Reasoning from fundamental truths toward the fundamental objectives of safety and effectiveness.
Safety and effectiveness are the fundamental objectives of the framework: established through the confidence framework and integrated throughout product development and lifecycle management, not demonstrated once for approval.
A justified level of belief that a medical product will achieve its intended benefits while maintaining acceptable levels of risk throughout its lifecycle.
Safe and effective medical products do not result from compliance alone. They result from sound decisions and organizational proficiency grounded in fundamental truths, cause-and-effect relationships, evidence, engineering, risk management, continuous learning, and improvement.
Compliance should support—not replace—the fundamental objectives of safety, effectiveness, and improved patient outcomes.
Increasing regulatory complexity and business, development, and commercialization pressure can drive organizations toward checklist compliance, process adherence, and milestone completion without sufficient consideration of the quality of the underlying decisions. MPSEI seeks to help advance three shifts.
These shifts do not diminish the importance of compliance, established processes, or business and development milestones. They reconnect each to its underlying purpose: sound decisions, appropriate readiness, safe and effective medical products, and better patient outcomes.
The pillars organize the work of first-principles safety and effectiveness.
Establish the confidence framework by determining what must be true for a medical product to be safe and effective, and integrate that framework into product development and lifecycle management.
Systematically apply inversion thinking within forward-thinking decision making. As we determine what is wanted or intended and how to achieve it, deliberately examine what is unwanted but could happen, how and why it could happen, and how it can be prevented or controlled. This first-principles approach integrates risk management into decision making throughout the medical product lifecycle.
Improve organizational proficiency and capability to consistently make sound safety and effectiveness decisions by applying first-principles thinking through effective leadership, governance, culture, evidence integration, cross-functional collaboration, and continuous learning, and provide the foundation for maturity assessment, benchmarking, continuous improvement, and recognition of demonstrated organizational proficiency.
Align diverse healthcare ecosystem stakeholders around shared first principles and the fundamental objectives of medical product safety, effectiveness, and patient outcomes, while fostering collaboration, shared learning, and collective action across organizational, disciplinary, geographic, and lifecycle boundaries.
Support lifecycle confidence through evidence, real-world experience, post-market learning, continuous monitoring, adaptation, and improvement.
Safe and effective medical products do not result from compliance alone. They result from sound decisions and organizational proficiency grounded in fundamental truths, cause-and-effect relationships, evidence, engineering, risk management, continuous learning, and improvement.
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