Initiatives

MPSEI initiatives organize first-principles safety and effectiveness work across medical product development, lifecycle management, decision quality, risk management, combination products, AI, and pharmaceutical lifecycle practice.

First-Principles Safety & Effectiveness Engineering for Medical Products
Establish a first-principles confidence framework that begins with the patient and intended benefit, and integrate it into product development and lifecycle management.
Read more about Safety & Effectiveness Engineering
First-Principles Risk Management for Medical Products
Systematically apply inversion thinking within forward-thinking decision making. As organizations determine what is wanted or intended and how to achieve it, they deliberately examine what is unwanted but could happen, how and why it could happen, and how it can be prevented or controlled, embedding effective risk management into decisions throughout the medical product lifecycle.
Read more about Risk Management
First-Principles Decision Excellence & Organizational Maturity
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. Through the RM3 Framework, this initiative will support organizational assessment, targeted improvement, benchmarking, and recognition of demonstrated maturity.
Read more about Decision Excellence & Organizational Maturity
First-Principles Safety & Effectiveness Engineering for Combination Products
Apply the first-principles safety and effectiveness confidence framework to the integrated development and lifecycle management of combination products, including the justified reuse and bridging of platforms, prior knowledge, and evidence.
Read more about Combination Products
First-Principles Safety & Effectiveness Engineering for AI
Apply the first-principles safety and effectiveness confidence framework to AI-enabled medical products and AI-enabled development and manufacturing processes, with an emphasis on continuous assurance as technologies and use conditions evolve.
Read more about AI
First-Principles Pharmaceutical Development & Lifecycle
Apply first-principles thinking to pharmaceutical development and lifecycle management by integrating product and process understanding, quality, risk management, manufacturing, and continuous improvement to build justified confidence in product safety and effectiveness.
Read more about Pharmaceutical Lifecycle
First-Principles Safety & Effectiveness Engineering for Cell & Gene Therapies
Apply the first-principles safety and effectiveness confidence framework to cell and gene therapy development, manufacturing, clinical delivery, and lifecycle management by integrating product and process understanding, patient-specific considerations, analytical characterization, manufacturing science, risk management, clinical evidence, and long-term learning.
Read more about Cell & Gene Therapies

First-Principles Risk Management for Medical Products

Systematically apply inversion thinking within forward-thinking decision making. As organizations determine what is wanted or intended and how to achieve it, they deliberately examine what is unwanted but could happen, how and why it could happen, and how it can be prevented or controlled, embedding effective risk management into decisions throughout the medical product lifecycle.

First-Principles Decision Excellence & Organizational Maturity

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. Through the RM3 Framework, this initiative will support organizational assessment, targeted improvement, benchmarking, and recognition of demonstrated maturity.

First-Principles Pharmaceutical Development & Lifecycle

Apply first-principles thinking to pharmaceutical development and lifecycle management by integrating product and process understanding, quality, risk management, manufacturing, and continuous improvement to build justified confidence in product safety and effectiveness.

First-Principles Safety & Effectiveness Engineering for Cell & Gene Therapies

Apply the first-principles safety and effectiveness confidence framework to cell and gene therapy development, manufacturing, clinical delivery, and lifecycle management by integrating product and process understanding, patient-specific considerations, analytical characterization, manufacturing science, risk management, clinical evidence, and long-term learning.

Initiatives

First-Principles Safety & Effectiveness Engineering for Medical Products

First-Principles Risk Management for Medical Products

First-Principles Decision Excellence & Organizational Maturity

First-Principles Safety & Effectiveness Engineering for Combination Products

First-Principles Safety & Effectiveness Engineering for AI

First-Principles Pharmaceutical Development & Lifecycle

First-Principles Safety & Effectiveness Engineering for Cell & Gene Therapies

Initiatives

First-Principles Safety & Effectiveness Engineering for Medical Products

First-Principles Risk Management for Medical Products

First-Principles Decision Excellence & Organizational Maturity

First-Principles Safety & Effectiveness Engineering for Combination Products

First-Principles Safety & Effectiveness Engineering for AI

First-Principles Pharmaceutical Development & Lifecycle

First-Principles Safety & Effectiveness Engineering for Cell & Gene Therapies