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,…
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…
Released in June 2024, the FDA’s draft guidance on Essential Drug Delivery Outputs (EDDO) provides critical recommendations for industry stakeholders involved in the development, production, and marketing of drug delivery devices and combination products. This guidance aims to ensure that medical devices intended for drug delivery perform as expected, guaranteeing patient safety and product efficacy….
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….
If you’re designing, marketing, or selling a medical device, you’re surely familiar with the fact that risk management is an ever increasingly important regulatory requirement and topic. The international ISO standard for risk management is 14971:2019; with few exceptions, regulating bodies worldwide recognize ISO 14971 as the requirement for a risk management process that will…
