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 human factors consulting firm specializing in usability engineering for medical devices and pharmaceuticals. They focus on ensuring products are safe, effective, and easy to use.
**Expertise & scope**
* Conducts comprehensive usability and human factors analyses, including cognitive walkthroughs, expert reviews, functional/task analyses, heuristic analyses, and user analyses.
* Performs various types of user research, such as competitive evaluation testing, contextual inquiry, formative and summative usability testing, international user research, labeling comprehension studies, and validation testing.
* Develops and tests Instructions for Use (IFUs) to ensure clarity and comprehension for intended users, considering factors like readability and layout.
* Provides participant recruiting services through their network to find representative users for research studies.
* Offers Institutional Review Board (IRB) services, registered with the U.S. Department of Health and Human Services, focusing on ethical treatment and protection of research subjects in non-drug studies.
**Reputation / proof points**
* Operates multiple locations including Philadelphia, Los Angeles, and Houston, as well as in Israel.
* Registered with the U.S. Department of Health and Human Services for IRB services.
Core Human Factors is a human factors consulting firm specializing in usability engineering for medical devices and pharmaceuticals. They focus on ensuring products are safe, effective, and easy to use.
**Expertise & scope**
* Conducts comprehensive usability and human factors analyses, including cognitive walkthroughs, expert reviews, functional/task analyses, heuristic analyses, and user analyses.
* Performs various types of user research, such as competitive evaluation testing, contextual inquiry, formative and summative usability testing, international user research, labeling comprehension studies, and validation testing.
* Develops and tests Instructions for Use (IFUs) to ensure clarity and comprehension for intended users, considering factors like readability and layout.
* Provides participant recruiting services through their network to find representative users for research studies.
* Offers Institutional Review Board (IRB) services, registered with the U.S. Department of Health and Human Services, focusing on ethical treatment and protection of research subjects in non-drug studies.
**Reputation / proof points**
* Operates multiple locations including Philadelphia, Los Angeles, and Houston, as well as in Israel.
* Registered with the U.S. Department of Health and Human Services for IRB services.
Additional information
Core Human Factors emphasizes a systematic approach to understanding how real people interact with products. They can identify potential use errors and safety concerns early in the design process through methods like cognitive walkthroughs, which can be performed with initial mock-ups before significant development investment. Their IFU development services integrate graphic design and human factors analysis to create clear, effective instructions that consider optimal font sizes and layout best practices. For participant recruiting, they leverage an established network to find suitable individuals for research studies.
Key Highlights
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Specializes in human factors consulting and usability engineering for medical devices and pharmaceuticals.
Source
“Core Human Factors provides expert human factors consulting and usability engineering for medical devices and pharmaceuticals.”
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Offers a full suite of services including research, IFU development, participant recruiting, and IRB services.
Source
“Core provides a full suite of services customized to each client and project.; Research; Instructions for Use (IFU) Development; IRB (Institutional Review Board) Services; Participant Recruiting”
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Conducts various research methods like cognitive walkthroughs, expert reviews, and formative/summative usability testing.
Source
“Examples include Cognitive Walk-throughs, Expert Reviews, Functional/Task Analyses, Heuristic Analyses, Human Factors Analyses / User Analyses, Threshold Analyses.”
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Provides IRB services registered with the U.S. Department of Health and Human Services for ethical research review.
Source
“The Institutional Review Board (IRB) of Core Human Factors, Inc. is registered with the U.S. Department of Health and Human Services to review plans for research for ethical treatment of subjects.”
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 and pharmaceutical companies seeking usability engineering expertise.
- Organizations needing to develop and validate Instructions for Use (IFUs).
- Companies requiring ethical review and oversight for user research studies.
How engagement typically works
- Project-based consulting.
- Collaborative development of user documentation.
- Research study design and execution.
Typical deliverables
- Human factors analysis reports.
- Usability testing protocols and reports.
- Validated Instructions for Use (IFUs).
- Participant recruitment services.
- IRB review documentation.
Good to know
- Best when clear, safe, and effective product use is a priority.
- Ideal for projects requiring regulatory compliance related to human factors and usability.
HQ:
Philadelphia, US
Languages:
English
Timezones:
UTC, EST
Status:
listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Spain, Europe
Industries:
Medical Devices
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
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Summative study, Validation testing
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing, Participant recruiting, IRB services
Standards Supported
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
3-5 business days
Minimum Project Size
Custom
Pricing Model
Custom
