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 offer a comprehensive suite of services designed to ensure products are safe, effective, and user-friendly.
**Expertise & scope**
* Conducts various types of research including competitive evaluation, contextual inquiry, formative and summative usability testing, and international user research.
* Provides expert consulting on task and use-related risk analysis, user analysis, and use specification development.
* Specializes in Instructions for Use (IFU) development, ensuring clarity and comprehension for end-users through human factors analysis and design best practices.
* Offers participant recruiting services 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 protection 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 ethics in research and streamlined, non-bureaucratic IRB review.
* Has a growing participant network for research studies.
* Maintains multiple office locations, including Philadelphia, Los Angeles, Houston, and Israel.
Core Human Factors is a specialized consulting firm focused on human factors engineering and usability for medical devices and pharmaceuticals. They offer a comprehensive suite of services designed to ensure products are safe, effective, and user-friendly.
**Expertise & scope**
* Conducts various types of research including competitive evaluation, contextual inquiry, formative and summative usability testing, and international user research.
* Provides expert consulting on task and use-related risk analysis, user analysis, and use specification development.
* Specializes in Instructions for Use (IFU) development, ensuring clarity and comprehension for end-users through human factors analysis and design best practices.
* Offers participant recruiting services 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 protection 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 ethics in research and streamlined, non-bureaucratic IRB review.
* Has a growing participant network for research studies.
* Maintains multiple office locations, including Philadelphia, Los Angeles, Houston, and Israel.
Additional information
Core Human Factors emphasizes a user-centered approach throughout the product development lifecycle. Their services are particularly valuable when addressing regulatory requirements for usability, such as those from the FDA and international bodies. They can assist in identifying potential use errors early in the design process through methods like cognitive walkthroughs and expert heuristic analysis, which can save significant time and cost compared to later-stage testing. Their IFU development services go beyond simple instructions, integrating graphic design and human factors principles to ensure optimal readability and comprehension, especially considering varying literacy levels among users. For clients needing to conduct research, their dedicated participant recruiting services and IRB review streamline the process, ensuring ethical standards are met.
Key Highlights
-
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.”
-
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”
-
Conducts various research methods such as 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.”
-
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
-
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 to review plans for research for ethical treatment of subjects.”
-
Offers streamlined, non-bureaucratic IRB review services.
Source
“allows us to offer streamlined, non-bureaucratic IRB review services in a cost-effective manner to our clients.”
Buyer Snapshot
Best for
- Medical device manufacturers
- Pharmaceutical companies
- Companies requiring usability and human factors expertise
How engagement typically works
- Project-based consulting
- Research and testing services
- IRB review and participant recruitment
Typical deliverables
- Usability testing reports
- Human factors analysis reports
- Instructions for Use (IFU) documentation
- Participant recruitment plans
- IRB submission documentation
Good to know
- Best when requiring specialized human factors and usability expertise for regulated products.
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
Minimum Project Size:
$25-50k
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, ISO 14971
User Types Supported
Lay user, Professional healthcare
Use Environments Supported
Home healthcare, Professional healthcare
Lead Time Band
Start in 2-4 weeks
Quote SLA
3-5 business days
Minimum Project Size
$25-50k
Pricing Model
Custom
