Core Human Factors
Core Human Factors, Inc.
★★★★★
4.6
/ 5
•
21 reviews
Core Human Factors provides expert human factors consulting and usability engineering for medical devices and pharmaceuticals. They specialize in research, IFU development, participant recruiting, and IRB services.
Core Human Factors offers a comprehensive suite of human factors consulting services tailored to the unique needs of medical device and pharmaceutical companies. Their expertise spans the entire product development lifecycle, from initial design analysis to post-market support. Key services include rigorous research methodologies such as analytical and observational studies, use-related risk analyses, and validation testing. They excel in developing clear and effective Instructions for Use (IFU) by integrating human factors principles into design, ensuring safety and efficacy. Core also facilitates participant recruiting through an extensive network and provides efficient Institutional Review Board (IRB) services, ensuring ethical treatment of subjects and streamlined reviews. With a focus on safety, efficacy, and user experience, Core Human Factors helps clients navigate complex regulatory requirements and create products that are both user-friendly and compliant. Their team of experts utilizes a deep understanding of user behavior and regulatory standards to deliver high-quality, cost-effective solutions. They have usability labs and consultants located in the US (Philadelphia, Los Angeles, Houston), Scotland, and Israel, enabling global research capabilities.
About
**Who they are**
Core Human Factors is a specialized human factors consulting firm focused on medical devices and pharmaceuticals. They offer a comprehensive suite of services designed to ensure product usability and safety.
**Expertise & scope**
* Conducts various research methodologies including competitive evaluation, contextual inquiry, formative and summative usability testing, and labeling comprehension studies.
* Provides expert human factors consulting, including cognitive walkthroughs, expert heuristic analysis, and user analysis.
* Specializes in Instructions for Use (IFU) development, ensuring clarity and readability for end-users, informed by human factors analysis and graphic design best practices.
* Offers participant recruiting services through their dedicated network to find representative users for research studies.
* Provides Institutional Review Board (IRB) services, registered with the U.S. Department of Health and Human Services, focusing on ethical treatment and welfare of research subjects.
**Reputation / proof points**
* Registered with the U.S. Department of Health and Human Services for IRB services.
* Operates with a focus on ethical research practices.
* Has multiple office locations including Philadelphia, Los Angeles, Houston, and Israel.
Core Human Factors is a specialized human factors consulting firm focused on medical devices and pharmaceuticals. They offer a comprehensive suite of services designed to ensure product usability and safety.
**Expertise & scope**
* Conducts various research methodologies including competitive evaluation, contextual inquiry, formative and summative usability testing, and labeling comprehension studies.
* Provides expert human factors consulting, including cognitive walkthroughs, expert heuristic analysis, and user analysis.
* Specializes in Instructions for Use (IFU) development, ensuring clarity and readability for end-users, informed by human factors analysis and graphic design best practices.
* Offers participant recruiting services through their dedicated network to find representative users for research studies.
* Provides Institutional Review Board (IRB) services, registered with the U.S. Department of Health and Human Services, focusing on ethical treatment and welfare of research subjects.
**Reputation / proof points**
* Registered with the U.S. Department of Health and Human Services for IRB services.
* Operates with a focus on ethical research practices.
* Has multiple office locations including Philadelphia, Los Angeles, Houston, and Israel.
Additional information
Core Human Factors emphasizes understanding how real people interact with products to identify potential use errors and safety concerns. Their services are designed to be integrated throughout the product development lifecycle, from early design mock-ups to final validation testing. They highlight the importance of clear communication in Instructions for Use (IFU), considering factors like reading levels and optimal design for comprehension. For clients needing to recruit participants, Core leverages an established network to ensure representative user groups are available for studies. Their IRB services are noted for being streamlined and cost-effective, particularly for non-drug behavioral studies.
Key Highlights
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Offers a full suite of human factors and usability engineering services tailored for medical devices and pharmaceuticals.
Source
“Core provides a full suite of services customized to each client and project.”
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Specializes in Instructions for Use (IFU) development, ensuring clarity and safety through human factors analysis and design.
Source
“our medical human factors consultancy is committed to crafting IFUs that clearly communicate with intended users of a product.”
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Provides participant recruiting services via a dedicated network to support research studies.
Source
“Utilizing our growing participant network and ongoing recruitment efforts, we can find representative users for research studies.”
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Offers IRB services registered with the U.S. Department of Health and Human Services, focusing on ethical research.
Source
“The Institutional Review Board (IRB) of Core Human Factors, Inc. is registered with the U.S. Department of Health and Human Services”
Certifications & Trust Signals
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Registered with the U.S. Department of Health and Human Services for IRB services.
Source
“The Institutional Review Board (IRB) of Core Human Factors, Inc. is registered with the U.S. Department of Health and Human Services”
Buyer Snapshot
Best for
- Medical device manufacturers
- Pharmaceutical companies
- Companies seeking to improve product usability and safety
How engagement typically works
- Project-based consulting
- Research study execution
- IRB review services
Typical deliverables
- Usability testing reports
- Human factors analysis reports
- Instructions for Use (IFU) documentation
- Participant recruitment
- IRB documentation
Good to know
- Best when seeking specialized expertise in medical device and pharmaceutical usability.
HQ:
Philadelphia, US
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Spain, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Usability Study Types Offered:
Formative study, Summative study
Services Offered:
Risk analysis, Task analysis, Instructions evaluation, Validation testing, User interface evaluation
User Types Supported:
Lay user, Professional healthcare
Use Environments Supported:
Home healthcare, Professional healthcare
Standards Supported:
FDA Human Factors Guidance, IEC 62366-1, IEC 62366-2
Has Participant Recruitment:
Yes
Participant Recruitment Details:
Utilizing our growing participant network and ongoing recruitment efforts, we can find representative users for research studies.
Has Usability Lab:
Yes
Has Remote Testing:
Yes
Regions Served:
USA, Scotland, Israel
Is Accredited:
No
Rush Available:
No
Nda Support:
No
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Summative study, Validation testing, Competitive Evaluation Testing, Labeling Comprehension Studies
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing, Participant recruiting, IRB services, Expert consulting
Standards Supported
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance
User Types Supported
Lay user, Professional healthcare
Use Environments Supported
Home healthcare, Professional healthcare
Lead Time Band
Start in 0-2 weeks
Quote SLA
24-48 hours
Minimum Project Size
Custom
Pricing Model
Custom
