Core Human Factors
Core Human Factors is a private human factors engineering consulting firm serving medical device and pharmaceutical companies with usability testing, validation studies, IRB services, and participant recruiting across US and Israel offices.
- Company typePrivate
- Founded2011
- HeadquartersBala Cynwyd, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Core Human Factors does
Core Human Factors, Inc. is a private, US-based human factors engineering consulting firm founded in 2011 and headquartered in Bala Cynwyd, Pennsylvania. The firm specializes in applying human factors and usability engineering methodologies to the design of medical devices and combination products, serving medical device companies, pharmaceutical companies, and combination product developers. Its core service lines include analytical and observational research (formative testing, use-related risk analyses, and human factors validation studies), Instructions for Use (IFU) development, in-house Institutional Review Board (IRB) services for behavioral studies, and a participant recruiting network that sources representative users for usability research.
The firm supports regulatory submissions across FDA pathways (510(k), De Novo, PMA, NDA, ANDA, BLA) and international bodies (EMA, Notified Bodies), positioning itself as a specialist partner for medical device manufacturers preparing human factors submissions. Core Human Factors operates from four offices across the United States (Bala Cynwyd, Chatsworth, Houston) and Israel (Netanya), and has integrated Human Factors Consulting Services, Inc. (HFCSI) into its team as part of the Rimkus family of companies following Rimkus' acquisition.
The business model is professional services-based: engagements are customized, project-based, and quoted per scope, sold directly to enterprise clients via relationship-driven sales, industry conference presence (notably the HFES International Symposium on Human Factors and Ergonomics in Health Care), and thought leadership content through the firm's blog. Revenue is not publicly disclosed. Leadership includes CEO Adam R. Shames and Director of Research Marc Egeth, PhD.
Core Human Factors firmographics
Firmographics- Name
- Core Human Factors
- Legal name
- Core Human Factors, Inc.
- Website
- https://corehf.com
- Company type
- Private
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Core Human Factors is a private human factors engineering consulting firm serving medical device and pharmaceutical companies with usability testing, validation studies, IRB services, and participant recruiting across US and Israel offices.
- Ownership category
- akta.pro rank
Core Human Factors industry classification
Industry- Product category
- Medical Device Human Factors Consulting
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
Keywords
Where Core Human Factors is headquartered
LocationHeadquarters
- HQ city
- Bala Cynwyd
- HQ country
- United States
- HQ region
- North America
Offices4 records
Markets served
Core Human Factors business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Others
Revenue model
- Human Factors Consulting Services: Professional consulting services provided to medical device and pharmaceutical companies for human factors engineering, usability testing, regulatory submission support, and related services. Services are customized to each client and project.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels3 records
Core Human Factors product offering
Product offeringCore offering
Core Human Factors is a B2B professional services firm that provides human factors and usability engineering consulting for medical device and pharmaceutical companies. Core offerings include analytical and observational research (formative testing, use-related risk analysis, validation studies), Instructions for Use (IFU) development, Institutional Review Board (IRB) services for behavioral studies, and participant recruiting to support regulatory submissions including FDA 510(k), De Novo, PMA, NDA, ANDA, and BLA filings.
Product overview
Core Human Factors provides a suite of human factors consulting services for medical device and pharmaceutical companies. The core offerings include Research Services (analytical and observational research, formative testing, use-related risk analyses, and validation studies), IFU Development (instructions for use with human factors analysis), IRB Services (institutional review board for behavioral research), and Participant Recruiting. The company was acquired by Rimkus and operates as part of their family of companies.
Differentiator
Problem solved
Functional benefit
Products and services
- Research Services Analytical and observational research involving all users, uses, and use environments. Includes human factors formative testing, use-related risk analyses, and human factors validation studies for medical device developers.
- IFU Development Instructions for Use development service that applies human factors analysis to design content highlighting safety and efficacy, with optimized layout, images, and readability for medical device users.
- IRB Services Institutional Review Board services focused on behavioral studies, with a streamlined review process and dedication to research ethics, offered to clients in a cost-effective, time-saving manner.
- Participant Recruiting Recruitment services that use a growing participant network and ongoing recruitment efforts to identify and schedule representative users for human factors research studies.
Companies that use Core Human Factors
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles2 records
Core Human Factors technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Core Human Factors partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core and minor.
- Human Factors Consulting Services, Inc. (HFCSI)coreHFCSI has been integrated into Core Human Factors team as part of the Rimkus acquisition. HFCSI provides human factors engineering and medical device consulting services including user-centered design, usability testing, and risk assessments.
- Chimera Consulting North America LLCminorStrategic collaboration for training programs on Human Factors-Usability and Design Controls for Drug Delivery Devices. Michael Gross, PhD, RAC of Chimera Consulting co-presents training programs with Adam R. Shames, MBA of Core Human Factors.
Scale indicators2 records
Recent moves5 records
Expansion highlights4 records
Core Human Factors competitors and assessment
Company assessmentDirect peers
- Human Factors Consulting Services, Inc. (HFCSI): HFCSI is a direct peer offering human factors engineering, usability testing, and risk assessments for medical devices. It has been integrated into Core Human Factors as part of the Rimkus acquisition, making it a near-identical service offering now operating under the same parent.
- Medical Device Usability: A boutique human factors consultancy focused on usability testing and validation studies for medical devices. It competes directly with Core on formative and summative human factors studies for FDA submissions.
- Research Collective: Research Collective is a human factors and user research consultancy serving medical device and healthcare clients. It competes with Core on usability testing, validation studies, and user research design.
- UserWise: UserWise is a human factors engineering consultancy focused on medical device usability testing and FDA submission support. Its service portfolio directly overlaps with Core's formative testing, validation, and use-related risk analysis offerings.
- Cognition Studio: Cognition Studio provides human factors and user experience consulting for medical devices, including usability testing, validation studies, and design controls. It competes with Core in the same niche of regulatory-grade human factors engineering.
Broad incumbents
- UL Solutions (Human Factors): UL Solutions operates a large human factors and usability engineering practice within its broader testing, inspection, and certification portfolio. It serves medical device and combination product manufacturers with global regulatory expertise and a much larger footprint than Core.
- Emergo by UL: Emergo by UL provides regulatory affairs, quality assurance, and human factors consulting for medical device and IVD companies. It overlaps with Core on human factors submissions and offers a much wider range of international regulatory services.
- ICON plc (Medical Device & Combination Product Services): ICON is a global CRO offering human factors and usability engineering within its broader clinical and regulatory portfolio. It serves combination product developers and device manufacturers with integrated human factors and clinical trial services, competing with Core at the larger end of the market.
- NAMSA: NAMSA is a medical device-focused CRO offering regulatory, quality, testing, and human factors services. Its human factors practice overlaps with Core on FDA submission support for device and combination product manufacturers.
Emerging players
- MedStar Health National Center for Human Factors in Healthcare: An applied research arm of MedStar Health conducting human factors research on medical devices and healthcare systems. While part of a hospital system, it conducts external human factors validation studies for device manufacturers, overlapping with Core's research service line.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Core Human Factors social profiles
Digital presenceCore Human Factors financial estimates
Financial estimateRevenue estimate
Valuation estimate
Core Human Factors leadership team
Management profileNumber of profiles
Profiles2 records
Core Human Factors funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Core Human Factors M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Core Human Factors
What does Core Human Factors do?
Core Human Factors is a B2B professional services firm that provides human factors and usability engineering consulting for medical device and pharmaceutical companies. Core offerings include analytical and observational research (formative testing, use-related risk analysis, validation studies), Instructions for Use (IFU) development, Institutional Review Board (IRB) services for behavioral studies, and participant recruiting to support regulatory submissions including FDA 510(k), De Novo, PMA, NDA, ANDA, and BLA filings.
Is Core Human Factors a public or private company?
Core Human Factors is a private company. It is classified as corporate owned and is currently operating.
When was Core Human Factors founded?
Core Human Factors was founded in 2011. It employs 11 to 50 people.
Where is Core Human Factors based?
Core Human Factors is headquartered in Bala Cynwyd, United States, in the North America region.
How does Core Human Factors make money?
One revenue line is on record: human Factors Consulting Services.
Who are Core Human Factors's main competitors?
Direct peers on record are Human Factors Consulting Services, Inc. (HFCSI), Medical Device Usability, Research Collective, UserWise and Cognition Studio. Broad incumbents are UL Solutions (Human Factors), Emergo by UL, ICON plc (Medical Device & Combination Product Services) and NAMSA. MedStar Health National Center for Human Factors in Healthcare is listed as an emerging player.
Does Core Human Factors have an API?
No public API is recorded for Core Human Factors.
What industry is Core Human Factors in?
Core Human Factors's product category is Medical Device Human Factors Consulting. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA). Its NAICS code is 54171 and its SIC code is 8731.