Human 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 on
INTAGE Healthcare Inc.If you have any questions or comments, please do not hesitate to contact us.
Contact UsINTAGE Healthcare’s Scope of Service
-
Marketing Research
From OTC products to ethical drugs and medical devices, we provide complete coverage of the healthcare market
- OTC Market Research
- Ethical Pharmaceutical Market Research
- Medical Device Research
- Quick Survey
- Global Research Service
-
Data Science Services
We contribute to the restructuring of a sustainable medical insurance system and the realization of optimal healthcare through various services based on data valuation concept.
- Health Economics and Outcomes Research (HEOR)
- DB Research
- Signal Management Service (Adverse Events Information Data Service)
- Drug Discovery Support
- Human Factors Engineering/Usability Engineering (HFE/UE)
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CRO Services
We support customers to solve their issues with abundant achievements, knowledge, and advanced nature in the CRO business.
- Clinical Development Support Services
- PMS Support Services
- Monitoring
- Patient Registration
- EDC-enabled Data Management
- Biostatistics
- Medical Writing
- Auditing/Self-inspection
- Pharmacovigilance (GVP)
- DB Survey
- EDC Services
- ADDIN Series
- ePRO (Patient Reported Outcomes System)