Proactive Risk Management as the Integrating Backbone of Combination Product Development

Combination Products (CPs) are becoming increasingly important within the pharmaceutical industry due to their potential to improve patient compliance, reduce use-related errors and enhance therapeutic effectiveness. However, integrating a medicinal product and a medical device into a single therapeutic system introduces significant technical, organizational and regulatory complexity.

This white paper presents a practical methodological framework for managing Combination Product development through iterative and proactive risk management. The proposed approach integrates pharmaceutical development, device engineering, usability engineering and regulatory expectations within a single risk-based decision-making framework.

Using the example of a pen injector system combined with a drug solution cartridge, the paper illustrates how task analysis, usability engineering, design controls and risk management can interact dynamically throughout the development lifecycle. Particular attention is given to the role of risk management in guiding design inputs, verification and validation activities, human factors studies and residual risk evaluation.

The paper ultimately positions risk management not merely as a compliance activity, but as the integrating backbone enabling consistent, efficient and robust Combination Product development.