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 consulting firm focused on human factors engineering and usability for medical devices and pharmaceuticals. They are dedicated to ensuring products are safe, effective, and intuitive for end-users.
**Expertise & scope**
* Conducts comprehensive usability testing, including formative and summative studies, to identify potential use errors and areas for improvement.
* Performs various analytical research methods such as cognitive walkthroughs, expert reviews, and heuristic analyses to evaluate designs early in the development process.
* Specializes in developing clear and understandable Instructions for Use (IFUs), informed by human factors principles and tested with representative users.
* Offers participant recruiting services to ensure research studies utilize appropriate user groups.
* Provides Institutional Review Board (IRB) services, registered with the U.S. Department of Health and Human Services, to review research plans for ethical treatment of subjects.
* Expertise extends to competitive evaluation, user analysis, and use specification development.
**Reputation / proof points**
* Offices located in 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 specialized consulting firm focused on human factors engineering and usability for medical devices and pharmaceuticals. They are dedicated to ensuring products are safe, effective, and intuitive for end-users.
**Expertise & scope**
* Conducts comprehensive usability testing, including formative and summative studies, to identify potential use errors and areas for improvement.
* Performs various analytical research methods such as cognitive walkthroughs, expert reviews, and heuristic analyses to evaluate designs early in the development process.
* Specializes in developing clear and understandable Instructions for Use (IFUs), informed by human factors principles and tested with representative users.
* Offers participant recruiting services to ensure research studies utilize appropriate user groups.
* Provides Institutional Review Board (IRB) services, registered with the U.S. Department of Health and Human Services, to review research plans for ethical treatment of subjects.
* Expertise extends to competitive evaluation, user analysis, and use specification development.
**Reputation / proof points**
* Offices located in 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 user-centered approach throughout the product development lifecycle. Their services are designed to integrate seamlessly, from initial concept analysis to final validation testing. They highlight the importance of understanding how real people interact with products in their intended environments, whether that's a clinical setting, a home, or a workplace. Engaging Core Human Factors can help mitigate risks associated with use errors, improve product adoption, and streamline regulatory submissions by ensuring compliance with human factors standards. Their IRB services offer a streamlined, cost-effective review process for behavioral 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 contextual inquiry.
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.
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 manufacturers seeking usability engineering expertise.
- Pharmaceutical companies requiring human factors analysis for drug delivery systems or related devices.
- Organizations needing to develop compliant and user-friendly Instructions for Use (IFUs).
How engagement typically works
- Project-based consulting
- Collaborative development support
- Research and testing services
Typical deliverables
- Usability testing reports
- Human factors analysis reports
- Instructions for Use (IFU) documentation
- Participant recruitment for studies
- IRB review documentation
Good to know
- Best when early engagement in the product development lifecycle is desired.
- Best when clear, user-tested instructions are a priority.
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, Both
Services Offered:
Risk analysis, Task analysis, Instructions evaluation, Validation testing, User interface evaluation, Other
User Types Supported:
Lay user, Professional healthcare, Both
Use Environments Supported:
Home healthcare, Professional healthcare, Both
Standards Supported:
FDA Human Factors Guidance, Other
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, Global
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
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing, Participant recruiting, IRB services
Standards Supported
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance, ISO 14971
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 hours
Minimum Project Size
Custom
Pricing Model
Custom
