Human 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.
- 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
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
- 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
We are able to provide HFE/UE-related services by leveraging our strength.
Healthcare Professional Recruitment Service
We support the recruitment of participants for usability tests and user research conducted by our customers within Japan and overseas.
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.
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 include the following products and explanatory materials.
- Prefilled syringe
- Kit type injector pen
- Cartridge type injector pen
- Prefilled nebulizer
- Skin patch
- 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
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)
We support customers to solve their issues with abundant achievements, knowledge, and advanced nature in the CRO business.
- Patient Registration
- EDC-enabled Data Management
- Medical Writing
- Pharmacovigilance (GVP)
- DB Survey
- PMS Solutions
- EDC Services
- ADDIN Series
- ePRO (Patient Reported Outcomes System)