serviceHuman Factors Engineering/Usability Engineering (HFE/UE)

Support for product development based on knowledge from user research and tests

In the development of medical devices, the application of human factors engineering (HFE) / usability engineering (UE) is required by medical device regulations.

In addition to reducing use-related risks based on risk management, the application of HFE/UE is important for launching products that meet user needs in a highly competitive market.

With our profound knowledge in user research and testing, we provide reliable HFE/UE services that go beyond simply complying with standards.

image scrollscroll image

Service Features

Point 1.
Ensure compliance with standards
Point 2.
Rigorous operation to ensure reliability
Point 3.
Support product development based on human-centered design with abundant knowledge of user evaluation
Point 4.
Simplify standards and guidance that are difficult to interpret
Point 5.
Flexible support from a series of activities to individual phase activities

Main Services

We provide the necessary support depending on the situation, from a series of activities to individual phase activities.


  • Develop HFE/UE plan
  • Support to organize existing information


  • Contextual inquiry
  • Ethnography
  • Interview
  • Focus groups
  • Diary study
  • Concept evaluation
  • Create use-related specifications


  • Known use-related problem analysis
  • Task analysis
  • Foreseeable use-related error analysis
  • Use-related risk analysis


  • Support for UI design
  • IFU design
  • Training design
  • Rapid prototyping and iterative evaluation


  • Formative usability test
  • Heuristic expert review
  • Usability comparison test
  • Labeling comprehension test


  • Summative usability test (HF validation)
  • IFU validation
  • Usability comparison test
  • Residual risk analysis


  • Support for preparation of HFE/UE report
  • Support for preparation of HF-related application documents
  • Support for handling HF application


  • HF training
  • Preparation of HFE/UE SOPs

Special Service

We are able to provide HFE/UE-related services by leveraging our strengths.

  • icon)

    Healthcare Professional Recruitment

    We assist in the recruitment of participants for usability tests and user research that our clients conduct within Japan and abroad.

  • icon)

    Preparation of Instructions for Use

    We prepare and evaluate HFE/UE-based instructions for use (IFU), quick reference guides (QRG) and other materials for healthcare professionals and patients/caregivers.

  • icon)

    Quick Concept Evaluation

    We are able to quickly conduct concept evaluations on domestic and international panels of healthcare professionals and patients/ caregivers managed by our company and group companies.


The following are examples of organizations that use our services.

  • Pharmaceutical companies providing combination products
  • Medical device manufacturers
  • Research institutions that develop medical devices
  • Academic institutions that develop medical devices
  • Pharmaceutical companies offering healthcare applications
  • Healthcare service/application providers
  • Product design companies/design research companies
  • Pharmaceutical affairs consultants/third party testing institutions

Target products

Target products include the following products and instructional materials.

Combination products

  • Prefilled syringe
  • Autoinjector
  • Kit type injector pen
  • Cartridge type injector pen
  • Inhaler
  • Prefilled nebulizer
  • Skin patch

Medical devices

  • Therapeutic instrument (dialysis machine, insulin pump, etc.)
  • Diagnostic device (endoscopes, CT/MRI, ultrasound device, IVD, etc.)
  • Testing equipment (hem-analysis device, pathological examination device, etc.)
  • Life support equipment (ventilator, defibrillator, etc.)

Digital health services

  • Therapeutic application
  • Drug information service
  • Digital health service
  • Digital integrated medical device
  • Medical information technology
  • Wearable device
  • Healthcare IoT device

For further information onINTAGE Healthcare Inc.

If you have any questions or comments, please do not hesitate to contact us.

Contact Us



INTAGE Healthcare’s Scope of Service