Proactive Risk Management as the Integrating Backbone of Combination Product Development
A practical framework for managing technical, organizational and regulatory complexity in Combination Product development
Author
Edoardo Mora, PTM Consulting Srl – Velferd Srl
Zenodo record
https://zenodo.org/records/20343592
License
Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)
Abstract
Combination Products are becoming increasingly important within the pharmaceutical industry because of 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 working 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.
Read the working paper on Zenodo
Key takeaways
| Core message | Key takeaway |
|---|---|
| Integration of disciplines | Combination Product development requires the integration of pharmaceutical, device and usability engineering disciplines. |
| Risk management as backbone | Risk management should act as the integrating backbone of the entire development lifecycle. |
| Iterative task analysis and risk assessment | Iterative task analysis and risk assessment improve consistency between design inputs, usability engineering and verification activities. |
| Early integration of human factors | Human factors and usability engineering should be integrated early during development rather than treated as late-stage validation activities. |
| Risk-based prioritization | Risk-based decision-making can support prioritization of verification, validation and labeling activities. |
| Structured integration of standards and principles | Structured integration between ISO 14971, ISO 62366-1, Design Controls and QbD principles strengthens development robustness. |
| Reduction of risk and complexity | A proactive methodological framework helps reduce product risk, regulatory uncertainty and project complexity. |
| Organizational and cultural integration | Combination Product development is not only a technical challenge, but also an organizational and cultural integration challenge. |
Suggested citation
Mora, E. (2026). Proactive Risk Management as the Integrating Backbone of Combination Product Development. MakingLife Working Papers | Pharma Science & Industry Series, Working Paper No. 2. DOI: 10.5281/zenodo.20343592
Disclaimer
This working paper is an analytical contribution intended for informational and scholarly communication purposes. It does not constitute regulatory, legal, commercial or investment advice.
