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.

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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.

Plan

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

Explore

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

Analyze

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

Design

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

Evaluate

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

Validate

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

Submit

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

Education

  • HF training
  • Preparation of HFE/UE SOPs

Special Service

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

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    Healthcare Professional Recruitment

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

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    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.

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    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.

Clients

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.

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INTAGE Healthcare’s Scope of Service