Medical Device Manufacturing: Environment, Engineering Control and Monitoring

  • R. Handy
  • M. Whitt
  • M. Lafreniere
  • M. J. JacksonEmail author


The trend toward an aging population in the highly developed countries of the world has the demand for innovative biomedical devices and tools at record levels. The products desired in this market are typically smaller and more portable than their predecessors, and require more sophisticated components and allied manufacturing technologies and automation techniques. In essence, similar to traditional consumer products, biomedical devices such as patient monitors, drug delivery systems, therapeutic devices, and life assisting devices have all decreased in size yet still have market expectations of enhanced performance characteristics and features. This chapter focuses on medical device manufacturing from the environmental, engineering control, and monitoring perspectives.


Medical device manufacturing Environmental controls Monitoring Manufacturing Medical devices 



The authors thank Springer and Wiley publishers for allowing the authors permission to reprint and update this chapter that was originally published in, ‘Surface Engineered Surgical Tools and Medical Devices,’ originally published by Springer in 2007 (ISBN 978-0387-27026-5). Reprinted with kind permission from Springer Science+Business Media B.V and Wiley Publishers.


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© Springer International Publishing Switzerland 2016

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Authors and Affiliations

  • R. Handy
    • 1
  • M. Whitt
    • 2
  • M. Lafreniere
    • 3
  • M. J. Jackson
    • 4
    Email author
  1. 1.School of MedicineThe University of UtahSalt Lake CityUSA
  2. 2.California State PolytechnicSan Luis-ObispoUSA
  3. 3.Ohio UniversityChillicotheUSA
  4. 4.Kansas State UniversitySalinaUSA

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