Combination products require more than pairing a drug with a delivery system. Their development demands coordinated planning across pharmaceutical, device, quality, regulatory, and clinical functions; often much earlier than organizations anticipate. While many companies recognize the importance of incorporating a device, it is still frequently introduced too late. This delay can create downstream challenges in design controls, human…
Combination products present a uniquely complex path from late-stage clinical development to commercial launch due to their need to comply with the corresponding drug, biologic, and medical device regulatory frameworks. The designation of Primary Mode of Action (PMOA) determines the lead regulatory authority and submission pathway, but it does not eliminate the obligation to address requirements from the non-lead constituent. As a…
Combination products; integrating drugs, devices, and biologics, are among the most complex innovations in modern healthcare. They promise significant benefits for patients by delivering convenience, safety, and effectiveness in one package. But with this promise comes heightened regulatory scrutiny, intricate development challenges, and the need for strong systems to manage risk. At the heart of…
Understanding a Streamlined Approach to Good Manufacturing Practice: Device-Sided vs. Drug-Sided Pathways in FDA’s CGMP Guidance Combination products such as drug-coated stents, prefilled syringes, and wearable injectors combine drug, device, and sometimes biologic components into a single product. While these products provide important therapeutic advantages, they also present unique regulatory challenges. To address these challenges,…
Risk management is central to ensuring the safety, quality, and efficacy of products in the healthcare sector. Two of the most prominent frameworks in this domain are ISO 14971 for medical devices and ICH Q9 for pharmaceuticals. While both aim to manage risks to patients, users, and the environment, they arise from different regulatory and…
In the highly regulated and rapidly evolving world of combination products, where drugs, devices, and/or biologics converge, the need for strategic portfolio management is more crucial than ever. One strategy gaining increasing traction is the platform approach. This model involves designing a foundational technology, system, or component that can be leveraged across multiple products within…
Origins and Overview of the V-Diagram The V-diagram emerged as a response to the complexities inherent in developing large-scale, high-reliability systems. Originally adopted in industries such as aerospace, defense, and automotive engineering, the model has since found applications in various domains where system safety, reliability, and performance are paramount. At its core, the V-diagram is…
Upon completion of the risk assessment, a comprehensive benefit-risk analysis is carried out. This vital step establishes the acceptability of product risk, carefully weighing the potential benefits against the identified risks. All of these critical measures culminate in the creation of a detailed risk management report, effectively summarizing the full range of risk management activities…
After determining the scope of the product risk management activities and documenting them in the Risk Management Plan, now the actual risk assessment can begin. In this article, we look at the various elements of what goes into a risk assessment for a product and how to determine the overall acceptability of the risks for…
When performing risk management activities for a medical device, those activities shall be planned according to the ISO 14971 risk management standard. The risk management process, if conforming to the standard, should include provisions for creating a Risk Management Plan to guide and govern the various steps involved in assessing the risk of the product….
