Agilis
Agilis is a privately held US consulting firm founded in 2000 that serves as a human factors partner for the medical market, providing consulting, risk analysis, training, and labeling services to MedTech and medical device developers.
- Company typePrivate
- Founded2005
- HeadquartersCave Creek, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Agilis does
Agilis is a US-based professional services firm headquartered in Cave Creek, Arizona, founded in 2000 and operating with 11-50 employees as a privately held for-profit company. It positions itself as a human factors partner for the medical market, delivering consulting, risk analysis, training, and labeling services to medical device developers. Founder and CEO Pat Patterson leads the firm, with the broader service taxonomy extending into design and innovation, product and device development, test engineering, human factors engineering, sterilization engineering, and quality assurance, marketed under the umbrella of accelerating MedTech development from concept to commercialization.
The firm's value proposition rests on integrating engineering, scientific, compliance, and project management expertise under a single engagement, supported by a 2,000 sq. ft. design lab and a network of testing partners. Marketing materials claim the firm has supported the creation of 70+ devices over the past five years and over 4,000 projects in the most recent year, though these figures are unverified and may reflect unit-level rather than full-engagement counts. Agilis emphasizes phase-appropriate maturity testing and early-stage manufacturability and usability integration, with the stated outcome of reducing redesigns, accelerating timelines, and improving first-submission cycle approval rates.
Go-to-market is direct, B2B consulting to MedTech and medical device companies, executed through senior professional engagement rather than product distribution. Marketing channels include thought leadership content, a podcast, monthly newsletter distribution to 10,000+ subscribers, case studies, and participation at BIO International and PDA/FDA conferences. Pricing is not publicly disclosed, consistent with a custom professional services model. The firm competes against larger MedTech consultancies and contract research organizations by focusing on the human factors niche and integrated compliance-engineering workflow.
Agilis firmographics
Firmographics- Name
- Agilis
- Legal name
- Kymanox
- Website
- https://agilisconsulting.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Agilis is a privately held US consulting firm founded in 2000 that serves as a human factors partner for the medical market, providing consulting, risk analysis, training, and labeling services to MedTech and medical device developers.
- Ownership category
- akta.pro rank
Agilis industry classification
Industry- Product category
- Medical Device Human Factors Consulting
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171)
- SIC
- Services-Management Consulting Services (8742), Services-Engineering, Accounting, Research, Management (8700)
- akta.pro primary industry
- Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ)
- akta.pro secondary industries
- Validation, Engineering & Facilities (CSV/Equipment/Utilities) Staffing FSP (HLAGAOAM), Manufacturing, MSAT & Operations Staffing (API/Biologics/Cell & Gene) (HLAGAOAL)
Keywords
Where Agilis is headquartered
LocationHeadquarters
- HQ city
- Cave Creek
- HQ country
- United States
- HQ region
- North America
Markets served
Agilis business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales
Distribution channels1 record
Marketing channels4 records
Agilis product offering
Product offeringCore offering
Agilis is a human factors partner for the medical market that provides consulting, risk analysis, training, and labeling services. The firm supports medical device companies in applying human factors engineering principles to ensure safe, effective, and usable products throughout the device development lifecycle.
Differentiator
Problem solved
Functional benefit
Products and services
- Human Factors Consulting Consulting services applying human factors engineering to medical device design, development, and usability validation for MedTech and medical device manufacturers.
- Risk Analysis Services Risk analysis services for medical device development, supporting identification and mitigation of use-related and design risks across the product lifecycle.
- Training Services Training programs for medical device teams on human factors engineering, usability, and regulatory compliance topics.
- Labeling Services Labeling services supporting medical device manufacturers in developing compliant, user-centered labeling and instructions for use (IFU).
Companies that use Agilis
Customer profileSegments1 record
Ideal customer profiles1 record
Agilis technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Agilis partnerships and signals
Strategic signalScale indicators3 records
Recent moves4 records
Expansion highlights4 records
Agilis competitors and assessment
Company assessmentDirect peers
- Kymanox: Kymanox is a life science consulting firm that integrates engineering, scientific, compliance, and project management expertise for MedTech, combination products, and biologics — a near-mirror of Agilis's value proposition, making it the most directly comparable peer in human factors and MedTech device consulting.
- StarFish Medical: StarFish Medical is a MedTech design, development, and contract manufacturing firm serving medical device companies. It overlaps with Agilis in device design, human factors engineering, and regulatory support for medical device clients.
- NAMSA: NAMSA is a MedTech-focused contract research organization and consulting firm offering testing, regulatory, and quality services to medical device manufacturers. It competes directly with Agilis in regulatory and human factors support for device submissions.
- Ximedica: Ximedica is a MedTech development services firm providing design, engineering, human factors, and regulatory services for medical device companies, directly comparable to Agilis's full-service device development and human factors offering.
- RQM+: RQM+ is a regulatory and quality consulting firm specializing in MedTech and IVD companies. Its focus on regulatory affairs, quality systems, and compliance services directly overlaps with Agilis's risk analysis and compliance offering.
Broad incumbents
- Phillips-Medisize: Phillips-Medisize is a large contract design, development, and manufacturing firm for MedTech and drug delivery. It offers overlapping human factors and device development services, but at a much larger scale and primarily as part of an end-to-end manufacturing offering.
- TÜV SÜD: TÜV SÜD is a global testing, inspection, and certification firm with a substantial MedTech practice offering regulatory, quality, and testing services. It is a broader incumbent that overlaps with Agilis on regulatory and compliance support for medical devices.
- Veranex: Veranex is a MedTech services company formed from the merger of Ximedica, Quartesian, and other firms, offering design, engineering, regulatory, and clinical services. It competes with Agilis across the full MedTech services stack but at significantly greater scale.
- Cambridge Consultants: Cambridge Consultants is a large, established product development and engineering consultancy with a significant MedTech practice. It is a broader incumbent that overlaps with Agilis on MedTech device design and human factors work, but across a much wider portfolio of industries.
Emerging players
- ProMed Pharma: ProMed Pharma is a contract manufacturer and development services firm for combination products and drug delivery devices. It overlaps with Agilis in combination product development and human factors for drug-device combination products.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks5 records
Key highlights6 records
Customer concentration
Agilis social profiles
Digital presenceAgilis financial estimates
Financial estimateRevenue estimate
Valuation estimate
Agilis leadership team
Management profileNumber of profiles
Profiles1 record
Agilis funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Agilis 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 Agilis
What does Agilis do?
Agilis is a human factors partner for the medical market that provides consulting, risk analysis, training, and labeling services. The firm supports medical device companies in applying human factors engineering principles to ensure safe, effective, and usable products throughout the device development lifecycle.
Is Agilis a public or private company?
Agilis is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Agilis founded?
Agilis was founded in 2005. It employs 11 to 50 people.
Where is Agilis based?
Agilis is headquartered in Cave Creek, United States, in the North America region.
Who are Agilis's main competitors?
Direct peers on record are Kymanox, StarFish Medical, NAMSA, Ximedica and RQM+. Broad incumbents are Phillips-Medisize, TÜV SÜD, Veranex and Cambridge Consultants. ProMed Pharma is listed as an emerging player.
Does Agilis have an API?
No public API is recorded for Agilis.
What industry is Agilis in?
Agilis's product category is Medical Device Human Factors Consulting. Its primary akta.pro industry code is HLAGAKAJ, Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA), with a secondary code of HLAGAOAM, Validation, Engineering & Facilities (CSV/Equipment/Utilities) Staffing FSP. Its NAICS code is 54171 and its SIC code is 8742.