Chapter 26: Development Challenges and Opportunities for Drug/Device Combination Products

  • Harold K. YeagerEmail author
  • Mary Roesner Brokovich
  • Michael J. Roe
  • Paul E. Jansen
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)


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.


Combination product Drug delivery system Design verification Organizational structure Project management Global standardization Privacy Cybersecurity 

Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  • Harold K. Yeager
    • 1
    Email author
  • Mary Roesner Brokovich
    • 2
  • Michael J. Roe
    • 3
  • Paul E. Jansen
    • 4
  1. 1.Yeager Device Solutions, LLCIndianapolisUSA
  2. 2.FishersUSA
  3. 3.Kaléo, Inc.RichmondUSA
  4. 4.Independent Device ConsultantBostonUSA

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