Chapter 26: Development Challenges and Opportunities for Drug/Device Combination Products
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Competent and timely development of drug delivery systems designed for self-administration requires a thoughtful organizational model, dedicated and centralized engineering project management, global design verification standards, and regulatory engagement. Advances in sensors, wireless communication technologies, mobile medical applications (MMA), and cloud-based data paradigms are empowering patients and healthcare providers. However, these opportunities are not without risk.