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The goals of human factors evaluation is to assess and document all interfaces between product users and the health product in anticipated environments of product.


Human Factors Evaluation Road Map


Human Factors: main fields of applications

  • Medical devices
  • Medical softwares including smartphone application
  • Food intake behavior
  • Satiety
  • Food preference
  • Diet adherence
  • Self-performed in-vitro diagnostic tests
  • Device-users interfaces
  • Ergonomics
  • Patient adherence
  • Interindividual adherence
  • Patient readiness complying with treatment regimen
  • Patient readiness maintaining behavior


Human factors evaluation scopes are adjusted according to the product development phase


  • Mastering human cognitive factors in the users’ requirements;
  • Mastering human factors leading to new health product preference and adoption;
  • Early detection of most appropriate population subsets for conducting product design verification and validation;
  • Compliance to Design History File documentation requirements;
  • Contribute in intellectual property claims beyond clinical aspects.


  • Ensure new health effectiveness taking into account human cognitive capabilities of targeted users in compliance with all applicable US 21CFR, FDA guidance, EC directives and guidance, ISO standards for Health Product registration and regulatory requirements.
  • Ensure product health safety in full compliance with all applicable US 21CFR, FDA guidance, EC directives and guidance, ISO standards for Health Product registration.
  • Health and hazardous risk reduction by appropriately selecting targeted users for conducting clinical trials based on psychosocial, cognitive and willingness to use profiles of targeted populations.
  • Contribute in strategic marketing development plan in preparation of product commercial launch considering psychosocial barriers and drivers for product adoption.


  • Refining of marketing strategy and tools based on strong psychosocial and consumer behavior knowledge;
  • Amplify and maintain user behavior leading to product adoption;
  • Contribute in setting-up warm and positive narrative of product use;
  • Publish psychosocial study results for supporting promotional campaign.

The overall outcomes of human factor evaluation is the characterization of targeted population readiness to adopt the health product in the environment and conditions of use of the product, as well as identify the barriers and the drivers for subject product adoption in routine practices.

Human Factors evaluation is mandatory for market approval in North America and EU countries for new medical devices and combination of medical devices with drugs such as self drug delivery systems, medical softwares, self in-vitro diagnosis tests.