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Steps in Device and Drug Pathway Development: Clinical Trials, Similarities, and Differences

  • Timur P. SaracEmail author
Chapter
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Part of the Success in Academic Surgery book series (SIAS)

Abstract

Bringing a new medical device or drug from benchtop to bedside is a long and arduous process and is very expensive. This chapter describes the stages of development for new medical devices and drugs and describes each while comparing the similarities and differences between the two with a focus on clinical trials. Much of this comes from a long personal history of direct involvement in medical device trials, in addition to writing a 510(k) and an IDE.

References

  1. 1.
    Pressman D. Patent it yourself. Berkeley, CA: Nolo Press; 2006. p. 56. ISBN 1-4133-0516-4.Google Scholar
  2. 2.
  3. 3.
    Chisum D. Volume 4A, Chapter 14. Priority by foreign filing, § 14.02 historical development. In: Chisum D, editor. Chisum on patents. Seattle: Matthew Bender LexisNexis; 2010.Google Scholar
  4. 4.
  5. 5.
    Harnack G. Mastering and managing the FDA maze: medical device overview. Milwaukee, American Society for Quality. .ISBN 9780873894555; 1999.Google Scholar
  6. 6.
    Giacovazzo C. Herbert Hauptman (1917–2011) Mathematician whose theories reveal the shapes of molecules from scattered X-rays. Nature. 2011;479:300.CrossRefGoogle Scholar
  7. 7.
  8. 8.
  9. 9.
    Herson J. Data and safety monitoring committees in Clinical Trials. Boca Raton, FL: CRC; 2009. ISBN 978-1-4200-7037-8.CrossRefGoogle Scholar
  10. 10.
    Snappin S, Chen MG, Jiang Q, Koutsoukos T. Assessment of futility in clinical trials. Pharm Stat. 2006;5(4):273–81.CrossRefGoogle Scholar
  11. 11.
  12. 12.
  13. 13.
  14. 14.
  15. 15.
  16. 16.
  17. 17.
  18. 18.
  19. 19.
  20. 20.
  21. 21.
  22. 22.
    Phases of medical device IDE trials.Google Scholar
  23. 23.
  24. 24.
  25. 25.
  26. 26.
  27. 27.
  28. 28.
  29. 29.
  30. 30.
  31. 31.
  32. 32.

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.The Ohio State University School of Medicine, Wexner Medical Center, The Ross Heart HospitalColumbusUSA

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