Human Factors MD

What Human Factors MD does

Human Factors MD (legal entity: Eurofins Human Factors MD, LLC) is a professional services firm founded in 2001 that provides human factors engineering (HFE) consulting exclusively to pharmaceutical and medical device manufacturers. The firm supports FDA regulatory submissions across multiple pathways (510(k), PMA, NDA, BLA, and ANDA) through an end-to-end service stack that includes HFE strategy development, HF integration plans, Use-Related Risk Analysis (URRA), use specifications, labeling development, gap analyses, threshold analyses, expert reviews, formative usability studies, summative validation studies, labeling comprehension studies, bridging studies, competitive benchmarking, and Human Factors Engineering Summary Reports for FDA submission packages. Its stated positioning is "only human factors, only medical," with the firm explicitly declining to work outside the medical product space. The company is headquartered in Charlotte, North Carolina, where it operates a purpose-built usability testing facility (opened 2016, expanded to three suites in 2020) capable of simulating home, hospital room, operating room, ICU, pharmacy, mass casualty, and central reprocessing environments, with multi-camera A/V recording and streaming.

The business model is project-based B2B professional services sold directly to enterprise medical device and pharmaceutical clients, typically tied to specific FDA submission programs. Customer segments are primarily Class I, II, and III medical device manufacturers and pharmaceutical companies developing combination products (pre-filled syringes, auto-injectors, pens, inhalers), with healthcare professionals and patients/caregivers acting as representative end-user participants in the firm's usability studies rather than direct paying customers. Pricing is engagement-based and not publicly disclosed. The senior team numbers roughly a dozen (Christina Mendat, PhD, serves as Managing Director alongside Senior Technical Director Liz Mauer and Technical Directors Corinna Proctor, Heather Colbert, and Vince Velocci; specialists include Lauren Horn, Kelly Seagren, Matthew Pacailler; lab operations led by Marissa Karagiannis and Ashley Lance; clinical consulting by Angela Hock, RN). Technical directors average 20+ years in medical human factors, with credentials spanning PhDs in experimental psychology, cognitive psychology, and biomedical engineering, plus Professional Engineer (P.Eng) and Certified Human Factors Professional (CHFP) certifications.

The firm is a wholly-owned subsidiary of Eurofins, a diversified scientific testing conglomerate, operating under the corporate name Eurofins Human Factors MD, LLC rather than through an independent equity structure; no separate funding rounds, M&A activity, or independent investor base are disclosed. Operational metrics for the trailing year include 2,200+ testing hours, 63 formative and validation studies, and 2,600+ study participants.

Name

Human Factors MD

Legal name

Eurofins Human Factors MD, LLC

Website

https://humanfactorsmd.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

11–50 employees

Short description

Human Factors MD is a Charlotte-based professional services firm founded in 2001 providing human factors engineering consulting exclusively to medical device and pharmaceutical companies, supporting FDA regulatory submissions across 510(k), PMA, NDA, BLA, and ANDA pathways.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Testing Laboratories and Services (54138)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)

akta.pro secondary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Human factors engineering
• Medical device testing
• Usability testing services
• FDA regulatory consulting
• Combination product testing

Headquarters

HQ city

Charlotte

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Human Factors Engineering Consulting Services: Project-based professional services including human factors strategy development, HF integration plans, gap analyses, threshold analyses, expert reviews, and regulatory meeting planning. Services provided to pharmaceutical and medical device clients throughout the product development and regulatory approval process.
2. Usability Testing Services: Formative usability studies, human factors validation testing, summative studies, labeling comprehension studies, and bridging studies conducted in their Charlotte testing facility with recruited participants.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Human Factors MD provides human factors engineering (HFE) consulting and usability testing services exclusively for pharmaceutical and medical device companies. The firm supports every stage of the product development and FDA regulatory process, including human factors strategy development, Use-Related Risk Analysis (URRA), formative and validation usability studies, bridging studies, labeling development, and Human Factors Engineering Summary Reports for 510(k), PMA, NDA, BLA, and ANDA submissions.

Product overview

Human Factors MD offers a unified suite of human factors engineering services exclusively for medical products. The core offering includes strategy development, risk analysis (URRA), formative and validation testing, and regulatory submission support. Key services include Use-Related Risk Analysis (URRA) as the foundational document, Formative Usability Studies for iterative design improvement, Human Factors Validation Testing for regulatory approval, and Bridging Studies for product line extensions. The company specializes in medical devices (Class I, II, III), Software as Medical Devices, Combination Products, and related products, supporting FDA submissions including 510(k), PMA, NDA, BLA, and ANDA applications.

Differentiator

Problem solved

Functional benefit

Products and services

• Human Factors Strategy & Consulting End-to-end human factors engineering consulting for pharmaceutical and medical device clients, covering strategy development, FDA meeting planning, integration planning, use specifications, labeling development, remediation planning, gap analyses, threshold analyses, expert reviews, and competitive benchmarking. Sold as project-based engagements to medical product development teams.
• Use-Related Risk Analysis (URRA) Documentation of the manufacturer's analysis of risk of harm when intended users use the medical product in the intended use environment. Serves as the backbone of a human factors program and supports FDA pre-market approval processes.
• Formative Usability Studies Usability testing conducted throughout product development — including exploratory studies, rapid iteration studies, and human factors pre-validation studies — designed to surface and resolve design issues before validation.
• Human Factors Validation Testing Comprehensive validation testing of medical devices and combination products with extensive participant recruitment across multiple user groups and simulated use environments (home, hospital, OR, ICU, pharmacy, mass casualty, central reprocessing). Delivered to support regulatory approval.
• Summative Studies Final validation studies to demonstrate that use-related risks have been adequately controlled and to support FDA premarket submissions.
• Labeling Comprehension Studies Studies that validate end users' understanding of product labeling and instructions for use, supporting labeling development and regulatory submissions.
• Bridging Studies Human factors studies conducted when manufacturers bridge information from one development program to support another program or application, ensuring the bridged product remains user-friendly, safe, and effective.
• Human Factors Engineering Summary Reports Comprehensive reports for FDA submissions (510(k), PMA, NDA, BLA, ANDA) documenting all human factors engineering efforts undertaken to design and develop a safe and effective medical product.

Quantifiable outcome

• 2200+ hours testing, 63 studies, 2600+ participants in the last year
• +1 more outcomes

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators7 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Lextant: Human factors and experience research consultancy with a medical device focus, supporting regulatory submissions, use error analysis, and usability testing. Overlaps directly with HFMD's regulatory-driven HF workflow.
• Bold Insight: User experience and human factors research firm with explicit medical device and healthcare practice. Competes on formative and summative usability studies for FDA submissions, including combination products.
• Research Collective: Usability and human factors research firm with dedicated medical device and pharmaceutical practice. Competes for the same validation testing, labeling comprehension, and bridging study work that HFMD performs.
• Userwise: Medical human factors consultancy providing usability engineering, use-related risk analysis, and validation testing. Specialty focus and client base closely mirror HFMD's.
• CoreHuman Factors: Specialty human factors consultancy focused on medical devices and combination products, providing URRA, formative usability, and summative validation testing. Directly comparable in service mix and target customer profile.
• Design Science: Long-standing medical device human factors and usability engineering consultancy serving FDA-regulated medical product developers. Closely matches HFMD's niche on 510(k)/PMA validation work, use-related risk analysis, and combination product testing.

Broad incumbents

• IQVIA: Global CRO whose broader clinical, regulatory, and device development services increasingly bundle human factors capabilities. Competes indirectly through program consolidation offerings to large pharma/medtech sponsors.
• Battelle: Large diversified applied science and research organization with a Human Centric Design and medical device human factors practice. Less niche than HFMD but competes for HF validation work and has broader federal/commercial reach.

Emerging players

• Syntax Health: Human factors and usability firm serving pharmaceutical and medical device sponsors, with capabilities overlapping HFMD's combination product and drug-delivery device work.
• National Center for Human Factors in Healthcare (MedStar): Hospital-system-affiliated research center focused on healthcare human factors and patient safety. Operates in adjacent territory (in-hospital usability and safety) rather than pre-market FDA validation, offering a partial overlap.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Human Factors MD