Helping innovators to develop safe products that meet users’ needs and regulatory requirements

The application of Human Factors, or Usability Engineering processes, into the development of medical devices, leads to safer and more intuitive products, as well as facilitating the regulatory approvals process, so accelerating the adoption and spread of innovative medical technologies. HTE is able to guide you through this process and conduct the required testing and assessments

Service Offerings:


Human Factors is an iterative process where design concepts, prototypes, and final products are assessed and reviewed by the intended users, which can include clinical or operational staff, as well as patients and carers.

Health Tech Enterprise is an independent provider of Human Factors services, conducted under IEC 62366-1:2015/AMD 1:2020. Typical services include:

  • Working with Health Tech companies to help plan and implement usability studies, identifying device user profiles, use environments, possible use errors, as well as identifying and assessing realistic use scenarios and clinical tasks.
  • Designing and Conducting Formative Evaluations. Formative Evaluations reduce risks in the design and development phase, as well as provide an opportunity to review preferred design concepts, layouts and formats. These studies, conducted with the intended users (clinicians and/or patients), examine use errors in identified tasks, review risks and safety implications, as well as assess the innovation’s overall ease of use.
  • Designing and Conducting Summative Testing. Usability testing of final products and product documentation (e.g. user manuals & IFUs) which is required when compiling technical files for final regulatory approval prior to product launch.

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