ClariMed
ClariMed is a US-headquartered, PE-backed (NaviMed Capital) MedTech services firm that delivers integrated human factors engineering, usability testing, regulatory strategy, quality systems, and digital solutions to pharmaceutical and medical device manufacturers across the US, UK and EU, operating from five global offices with 70+ consultants.
- Company typePrivate
- Founded2023
- HeadquartersChadds Ford, United States
- Headcount51–100
- GTM typeB2B
- OfferingServices
What ClariMed does
ClariMed is a human-centered medical device development and regulatory services firm headquartered in Chadds Ford, Pennsylvania, that provides an integrated end-to-end platform spanning human factors engineering, usability testing, quality management system (QMS) services, regulatory strategy, digital/UX design, AI/ML integration, cybersecurity, and market research. Founded in January 2023 as a platform investment by healthcare-focused private equity firm NaviMed Capital ($400M+ AUM), the company was built by simultaneously acquiring two established human factors boutiques — UserWise (San Jose, January 2023) and Harvey Medical (Cambridge UK, February 2023) — and has since added We Are Human (Atlanta, August 2025). Under CEO Kelley Kendle, the company has scaled from approximately 20 to 70+ consultants across five global offices (Chadds Ford PA, Cambridge MA, San Jose CA, Atlanta GA, Cambridge UK and Leeds UK), achieving ISO 13485:2016 certification in July 2025 and Inc. 5000 recognition in September 2025.
The company's core technology is a five-phase iterative usability engineering methodology — user research, risk analysis, iterative prototyping/testing, usability validation, and HF submission support for FDA and CE marking — combined with specialized simulated-use environments (10,000 sq ft facilities in San Jose and Cambridge UK featuring surgical suites, observation areas and a functioning ambulance simulator) that allow realistic formative and validation testing across home, clinical and surgical contexts. Service delivery is offered through four commercial models: project-based consulting, embedded resources, monthly retainers, and end-to-end multi-year partnerships, allowing sponsors to scope engagements from a single HF validation study to a full product lifecycle program.
ClariMed targets pharmaceutical and medical device manufacturers, with a secondary segment in digital health and SaMD companies; named engagements include Béa Fertility (UK at-home ICI kit), a large international pharmaceutical company (migraine inhaler, biosimilar prefilled syringes for AMD/DME), a rechargeable implanted system developer, and a kidney transplant device developer. Marketing relies on thought leadership content, industry conference presence (MD&M West, MEDevice Silicon Valley, Pharmapack Europe, EU Medical Device Human Factors Conference), webinars, and direct B2B enterprise sales across the US, UK and EU markets.
ClariMed firmographics
Firmographics- Name
- ClariMed
- Legal name
- ClariMed, Inc.
- Website
- https://clarimed.com
- Company type
- Private
- Founded year
- 2023
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- ClariMed is a US-headquartered, PE-backed (NaviMed Capital) MedTech services firm that delivers integrated human factors engineering, usability testing, regulatory strategy, quality systems, and digital solutions to pharmaceutical and medical device manufacturers across the US, UK and EU, operating from five global offices with 70+ consultants.
- Ownership category
- akta.pro rank
ClariMed industry classification
Industry- Product category
- Medical Device Regulatory & Development Services
- NAICS
- Scientific Research and Development Services (5417), Professional, Scientific, and Technical Services (541), Computer Systems Design and Related Services (54151)
- SIC
- Services-Health Services (8000), Services-Computer Programming Services (7371)
- akta.pro primary industry
- Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)
- akta.pro secondary industry
- DTx/SaMD Deployment, Integration & Reimbursement Enablement (HLACANAO)
Keywords
Where ClariMed is headquartered
LocationHeadquarters
- HQ city
- Chadds Ford
- HQ country
- United States
- HQ region
- North America
Offices6 records
Markets served
ClariMed business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Professional Services - Human Factors & Usability Studies: Consulting services for human factors engineering, usability testing, and market research to support medical device development and regulatory submissions.
- Strategy & Advisory Services: Regulatory strategy, gap analysis, agency representation, and compliance advisory services for global markets (US, EU, China, Japan).
- Quality Services: Quality management system implementation, document control, design control, audits, and risk management services aligned with ISO 13485, ISO 14971, and regulatory requirements.
- Digital Solutions: UI/UX design, software development, AI/ML integration, cybersecurity solutions, and cloud connectivity services for medical devices and digital health products.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Project-Based Consulting |
| Other | Monthly | Embedded Resources |
| Subscription | Monthly | Retainer Model |
| Other | Multi-year contract | End-to-end Services |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels6 records
ClariMed product offering
Product offeringCore offering
ClariMed provides integrated, end-to-end human-centered medical device, combination product, and IVD development services. The firm delivers human factors and usability engineering studies, quality management system implementation, regulatory strategy and advisory, digital/UI-UX design, cybersecurity, AI/ML integration, and qualitative market research to pharmaceutical and medical device manufacturers across US, UK, and EU markets. Services are offered through project-based, embedded resource, retainer, and full-lifecycle engagement models.
Product overview
ClariMed is a human-centered medical device development and regulatory services company offering an integrated, end-to-end service platform. The core offerings include Human Factors & Usability Studies, Quality Services (QMS), Digital Solutions, Strategy & Advisory, and Market Insights, delivered through flexible engagement models (Project-Based Consulting, Embedded Resources, Retainer Model, and End-to-End). The company has grown through acquisitions of UserWise (human factors/usability engineering), Harvey Medical (UK/EU human factors and market research), and We Are Human (Southeast US usability), all now fully integrated into ClariMed's unified practice.
Differentiator
Problem solved
Functional benefit
Products and services
- Human Factors & Usability Studies
- Quality Services (QMS)
- Digital Solutions
- Strategy & Advisory
- Market Insights
Quantifiable outcome
- Reduced document approval and release timeline by 40% for auto-injector manufacturer client
- +2 more outcomes
Companies that use ClariMed
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles3 records
ClariMed technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature3 records
ClariMed partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered key and core.
- We Are HumankeyAcquired Atlanta-based usability lab and expert team led by Principal Annmarie Nicolson, expanding ClariMed's presence in the Southeast US market.
- Harvey MedicalcoreAcquired UK-based Harvey Medical, a medical human factors and market research provider with offices in Cambridge, UK and Utrecht, NL. Founder Louisa Harvey serves as Principal. The acquisition expanded ClariMed's European footprint and regional expertise.
- UserWise, LLCcoreAcquired San Jose-based UserWise, the leading independent human factors provider offering human factors and usability engineering services, usability study recruitment, market research facilities, and IRB services. Founder Shannon Clark continues to lead the organization.
Scale indicators6 records
Recent moves11 records
Expansion highlights6 records
ClariMed competitors and assessment
Company assessmentBroad incumbents
- Certara: Regulatory and scientific services firm (parent of Synchrogenix) employing ClariMed CEO Kelley Kendle previously. Overlaps on regulatory strategy, medical writing, and combination product support, though Certara is more pharma/clinical-focused.
- IQVIA: Global CRO and life sciences services giant with MedTech and human factors practices. Competes with ClariMed on large enterprise engagements where bundled CRO offerings can undercut specialist pricing, though lacks ClariMed's pure-play human factors depth.
- Medpace: Mid-sized clinical CRO with growing medical device and combination product practice. Larger scale and broader clinical scope than ClariMed, but overlapping regulatory/human factors service lines for medical product sponsors.
Direct peers
- Ximedica: Medical device design, development, and manufacturing services firm providing human factors engineering, regulatory, and quality services. Closely comparable integrated MedTech services platform; Ximedica adds contract manufacturing capability.
- NAMSA: Medical device-focused CRO providing regulatory, quality, and testing services including human factors and usability engineering. Comparable to ClariMed in target customer (MedTech manufacturers) and integrated service platform model.
- Cambridge Consultants: Product development consultancy with medical device practice including human factors engineering and regulatory support from Cambridge UK. Comparable scale and service model, including premium-priced innovation work for medtech/pharma.
- Invetech: Medical device product development and manufacturing services firm with human factors and design control capabilities. Comparable end-to-end services model targeting combination products and regulated devices.
- Design Science Consulting: Boutique human factors and usability engineering consultancy serving medical device and pharmaceutical clients. Most direct pure-play HF peer to ClariMed, particularly in user research and validation testing services.
- Sagentia: Product development and technology consulting firm with medical device and life sciences practice offering human factors, regulatory, and software/digital services. Comparable integrated offering and similar customer base of mid-to-large MedTech clients.
- Emergo by UL: UL's human factors and regulatory consulting practice for medical device and IVD manufacturers; competes directly with ClariMed on usability engineering, regulatory strategy, and global market access (US FDA, EU MDR, etc.). Closest direct peer in service scope.
Market position
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
ClariMed social profiles
Digital presenceClariMed compliance and trust
Trust signalCompliance4 records
ClariMed financial estimates
Financial estimateRevenue estimate
Valuation estimate
ClariMed leadership team
Management profileNumber of profiles
Profiles10 records
ClariMed subsidiaries and ownership
Company hierarchySubsidiaries3 records
ClariMed funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ClariMed M&A and investment
M&A and investmentM&A2 records
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ClariMed
What does ClariMed do?
ClariMed provides integrated, end-to-end human-centered medical device, combination product, and IVD development services. The firm delivers human factors and usability engineering studies, quality management system implementation, regulatory strategy and advisory, digital/UI-UX design, cybersecurity, AI/ML integration, and qualitative market research to pharmaceutical and medical device manufacturers across US, UK, and EU markets. Services are offered through project-based, embedded resource, retainer, and full-lifecycle engagement models.
Is ClariMed a public or private company?
ClariMed is a private company. It is classified as private equity controlled and is currently operating.
When was ClariMed founded?
ClariMed was founded in 2023. It employs 51 to 100 people.
Where is ClariMed based?
ClariMed is headquartered in Chadds Ford, United States, in the North America region.
How does ClariMed make money?
Four revenue lines are on record. Professional Services - Human Factors & Usability Studies are the primary driver. The others are strategy & Advisory Services, quality Services and digital Solutions.
Who are ClariMed's main competitors?
Broad incumbents on record are Certara, IQVIA and Medpace. Direct peers are Ximedica, NAMSA, Cambridge Consultants, Invetech, Design Science Consulting, Sagentia and Emergo by UL.
Does ClariMed have an API?
No public API is recorded for ClariMed.
What industry is ClariMed in?
ClariMed's product category is Medical Device Regulatory & Development Services. Its primary akta.pro industry code is HLAGAAAL, Specialty Therapeutic-Area CROs (e.g., oncology/rare disease), with a secondary code of HLACANAO, DTx/SaMD Deployment, Integration & Reimbursement Enablement. Its NAICS code is 5417 and its SIC code is 8000.