Drug Device Combination Products

Book Overview: Drug-Device Combination Products: Design, Regulation, and Performance In an era of rapidly evolving healthcare technology, Drug-Device Combination Products by Shane Robinson serves as an essential guide to one of the most complex and dynamic segments of modern medicine. This comprehensive handbook offers an in-depth exploration of combination products-therapeutic innovations that integrate pharmaceutical drugs, medical devices, and biologics to create unified solutions for enhanced patient care. Through meticulously detailed chapters, the book navigates the scientific, regulatory, and engineering challenges involved in developing these products. From pre-filled syringes and auto-injectors to advanced pen injector systems, readers gain insight into real-world examples of how these systems are transforming treatment delivery for chronic conditions such as diabetes, asthma, and cardiovascular disease. The text delves into regulatory frameworks including FDA's 21 CFR Part 4 and the EU Medical Device Regulation (MDR 2017/745), guiding readers through compliance with quality systems, design controls, and risk management. The integration of ISO standards such as ISO 13485 and ISO 14971 further reinforces the book's focus on global harmonization. Robinson expertly outlines critical topics such as usability engineering, biocompatibility testing, performance validation, and lifecycle management. With technical depth and regulatory clarity, the book bridges pharmaceutical sciences, biomedical engineering, and quality assurance-offering practical tools for industry professionals, regulatory specialists, and developers of combination products. Whether for those new to the field or seasoned professionals seeking up-to-date reference material, Drug-Device Combination Products delivers a foundational yet forward-looking perspective on creating safe, effective, and compliant therapeutic technologies. Introduction to Combination Products FDA and EU Definitions of Combination Products Regulatory Frameworks: FDA 21 CFR Part 4 and EU MDR 2017/745 Types of Combination Products (Single-entity, Co-packaged, Cross-labelled) Design Controls for Combination Products Risk Management in Combination Product Development Essential Performance Requirements (EPRs) and EDDOs Human Factors and Usability Engineering Design Inputs and Design Outputs Verification and Validation Testing Clinical Evaluation and Performance Requirements Technical Considerations for Pen Injectors and Auto-Injectors Material Selection and Compatibility for Drug-Device Systems Biocompatibility Testing per ISO 10993-1 Sterility and Container Closure Integrity Testing Shelf Life and Stability Studies Usability Design and Risk Mitigation by Design Performance Testing: Injection Time, Force, Dose Accuracy Software Integration and Medical Device Software Safety Post-Market Surveillance and Vigilance Systems Labeling and Instructions for Use (IFU) Design Change Management and Lifecycle Control Clinical Trials and Post-Market Clinical Follow-Up (PMCF) Application of ISO 13485 and ISO 14971 Protective Measures and Information for Safety Packaging and Environmental Use Conditions Design History File (DHF) and Risk Management File (RMF) Sterilisation Techniques and Aseptic Processing Automation and Electronics in Needle-Based Injection Systems EU GMP Annexes and Manufacturing for Sterile Products