• Publication Date: 08/01/2014
  • Author(s):
    Leichter, Lee Phillips, Sean
  • Organization(s):
    Continuum Advanced Systems P/L Biomedical
  • Article Type: Technical Articles
  • Subjects: Device Design, Industry Issues and Trends, Testing, Validation, and Regulatory Compliance
A review of US and EU regulations driving human factors and considerations for modifying products in response to patients' needs.

This article summarizes the historic and current US and European regulations driving human factors. The authors also explore some of the more common cognitive, physical, social and environmental use challenges seen with pMDIs and DPIs and discuss how these devices can challenge patients, the types of research that can be employed to better understand these concerns, and various mitigations that can be designed to help improve inhaler usability and adherence.

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