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Addressing the patient-device use interface: Development and laboratory validation of a facemask with anatomically-responsive face models

  • Publication Date: 04/01/2013
  • Author(s):
    Coppolo, Dominic P. Engelbreth, Dan Mitchell, Jolyon P. Morton, Robert W. Nagel, Mark W.
  • Organization(s):
    Monaghan Medical Corporation Trudell Medical International
  • Article Type: Technical Articles
  • Subjects: Device Design, Instruments, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
Face models facilitate critical performance evaluation of orally inhaled products in clinically-appropriate ways

Many patients, particularly the very young, the elderly and those with co-morbidities affecting coordination, need to use a facemask rather than a mouthpiece in order to receive inhaled medication via a pressurized metered dose inhaler with valved holding chamber (pMDI-VHC). This article explores the steps taken to design a range of facemasks that are age-of-user-appropriate. In addition, it discusses the ways the infant version has been validated in the laboratory.

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