serviceHuman Factors Engineering/Usability Engineering (HFE/UE)

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

In medical device development, the application of human factors engineering (HFE) and usability engineering (UE) is required by laws, regulations and international standards.

In addition to reducing use-related risks based on risk management, the application of HFE/UE is important to launch products that meet user needs in more competitive markets.

With our profound knowledge on user research and testing, we provide a robust HFE/UE service that is not just in line with standards.

image scrollscroll image

Service Features

Point 1.
Secure compliance to standards
Point 2.
Strict operation that guarantees 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 handling from a series of activities to individual phase activities

Main Services

We provide support as the situation requires, 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


  • Analyze use-related issues
  • Task analysis
  • Analyze potential use errors
  • Analyze use-related risks


  • 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


  • Comprehensive usability test (HF validation)
  • IFU validation
  • Usability comparison test
  • Post-test 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 strength.

  • icon)

    Healthcare Professional Recruitment Service

    We support the recruitment of participants for usability tests and user research conducted by our customers within Japan and overseas.

  • icon)

    Instructions for Use of Preparation Service

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

  • icon)

    Quick Concept Evaluation Service

    We are able to quickly conduct concept evaluation for healthcare professionals, patients/caregivers panels in Japan and overseas handled by our company and our group company.


The following are examples 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 providing 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 explanatory 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 (endoscopic instrument, CT/MRI, ultrasound device, IVD, etc.)
  • Testing equipment (hem-analysis device, pathological examination device, etc.)
  • Life support equipment (respirator, 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