Simbex
Simbex is a Lebanon, New Hampshire-based medical device and consumer health product design and development firm offering end-to-end engineering, AI, regulatory, and commercialization services. Founded around 2000, it serves startups, Fortune 500 firms, and university TTOs, and was acquired by Riddell in April 2024.
- Company typePrivate
- Founded2004
- HeadquartersLebanon, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Simbex does
Simbex is a US-based medical device and consumer health product design and development firm headquartered in Lebanon, New Hampshire, founded in 2000 (per firmographic data; alternative source dates founding to 2004). The company provides end-to-end engineering and commercialization services — including mechanical and electrical engineering, embedded software and web development, AI/ML development, human factors design, regulatory affairs, and quality system implementation — to medical device startups, Fortune 500 corporations, university technology transfer offices, and consumer health companies. With 11–50 employees, ISO 13485 certification, and 20+ years of experience supporting more than 550 clients, Simbex operates on a project-based B2B professional services model with quote-based pricing; revenue is not publicly disclosed.
Simbex complements its services with two proprietary assets: ActiveStep, an instrumented perturbation treadmill for fall-prevention and research applications, and the TREAT Methodology, a commercialization framework developed during the company's tenure (2010–2020) as the coordinating center for the NIH-funded Center for Translation of Rehabilitation Engineering Advances and Technology. The firm has published AI capabilities spanning predictive analytics, generative adversarial networks for synthetic data, computer vision, and process automation, applied to biometric sensor processing, IoMT systems, and context-aware wearable platforms. Named public clients include Riddell (now the company's acquirer), MedRhythms, InnoVoyce, and OPOS1.
In April 2024, Riddell acquired Simbex to integrate its wearable sensor and biomechanics capabilities into Riddell's athlete performance platform, repositioning the firm as a subsidiary focused on sports safety while retaining its broader medical device and consumer health practice.
Simbex firmographics
Firmographics- Name
- Simbex
- Legal name
- Simbex
- Website
- https://simbex.com
- Company type
- Private
- Founded year
- 2004
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Simbex is a Lebanon, New Hampshire-based medical device and consumer health product design and development firm offering end-to-end engineering, AI, regulatory, and commercialization services. Founded around 2000, it serves startups, Fortune 500 firms, and university TTOs, and was acquired by Riddell in April 2024.
- Ownership category
- akta.pro rank
Simbex industry classification
Industry- Product category
- Medical Device Design & Development Services
- NAICS
- Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Clinical Trial Supply, Logistics & Vendor Management FSP (HLAGAOAH)
Keywords
Where Simbex is headquartered
LocationHeadquarters
- HQ city
- Lebanon
- HQ country
- United States
- HQ region
- North America
Markets served
Simbex business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Simbex product offering
Product offeringCore offering
Simbex provides end-to-end medical device and consumer health product design and development services, spanning mechanical and electrical engineering, software and firmware, AI/ML development, human factors design, regulatory affairs, quality systems, and commercialization strategy. The firm also develops and sells its own products, including the ActiveStep instrumented perturbation treadmill used for fall-prevention and rehabilitation research. Services are delivered as integrated, multidisciplinary engagements from ideation through regulatory submission and market launch.
Product overview
Simbex is a medical device and consumer health product design and development partner offering a comprehensive platform of integrated services. The core offering encompasses Mechanical & Electrical Engineering, Software & Web Development, AI Development Services, Design & Human Factors, and Commercialization Strategy as interconnected service modules. Supporting services include Regulatory Services and Quality as a Service. The company has developed proprietary products including ActiveStep (perturbation treadmill for fall prevention) and the TREAT Methodology (commercialization framework). With 20+ years of experience supporting 550+ clients, Simbex operates as both a service provider and product developer, having been acquired by Riddell in 2024.
Differentiator
Problem solved
Functional benefit
Products and services
- Medical Device & Consumer Health Product Design & Development Comprehensive end-to-end design and development services for medical devices and consumer health products, spanning ideation, engineering, prototyping, regulatory submission, and commercialization support for medical device startups, Fortune 500 companies, and consumer health firms.
- Regulatory Services Standalone regulatory consulting for FDA and EU MDR compliance, including premarket submissions, CE marking, quality system regulation guidance, and post-market surveillance for medical device companies.
- Quality as a Service Managed quality management system implementation and operation for ISO 13485, 21 CFR 820, and EU MDR compliance, providing tailored quality systems for medical device companies that lack in-house QA infrastructure.
- Commercialization Strategy Services Expert commercialization consulting using the proprietary Simbex Commercialization Methodology, covering business model development, regulatory strategy, reimbursement strategy, market assessment, competitive analysis, patent development and evaluation, and fundraising guidance.
- Technology Transfer Office Services Specialized commercialization services for universities, research institutes, and hospitals, including due diligence, market analyses, customer discovery, and grant application review support for technology transfer offices.
- ActiveStep Instrumented perturbation treadmill developed by Simbex for clinical fall-prevention training and rehabilitation research applications.
Companies that use Simbex
Customer profileSegments4 records
Ideal customer profiles4 records
Simbex technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability7 records
Simbex partnerships and signals
Strategic signalRecent moves5 records
Expansion highlights5 records
Simbex competitors and assessment
Company assessmentDirect peers
- Kablooe Design: Medical device and product design firm offering concept, design, engineering, and manufacturing transfer. Comparable boutique medtech design services firm.
- StarFish Medical: Canadian medical device design, development, and contract manufacturing firm offering end-to-end services from concept to commercialization. Closest direct analog to Simbex in scale, service scope, and client type (medtech startups to Fortune 500).
- Minnetronix Medical: Medical device design, engineering, and manufacturing firm serving therapeutic device OEMs. Comparable in combining regulated design services with manufacturing transfer and quality system support.
- Product Development Technologies (PDT): Medical and consumer product design/development firm offering mechanical, software, and human factors services. Comparable full-stack product development partner serving regulated medical device clients.
- Ximedica: Medical device and diagnostics design/development partner (acquired by Flex) covering mechanical, software, human factors, and regulatory. Directly comparable full-service medtech engineering services model.
- Cambridge Consultants: Global product development and technology consulting firm with a major medical device practice covering wearables, diagnostics, and AI-enabled devices. Comparable end-to-end medtech engineering services with deeper international reach.
- Invetech: Consulting and engineering firm specializing in medical device, diagnostics, and industrial automation product development. Comparable services model with focus on regulated product commercialization.
- HS Design: Medical device design and development firm providing industrial design, human factors, mechanical engineering, and regulatory services. Comparable mid-sized full-service medtech engineering partner.
Regional players
- Nelson Labs: Medical device testing and lab services firm (now part of Sotera Health) providing sterility, biocompatibility, and validation testing. Adjacent comparator for Simbex's quality-as-a-service and regulatory offerings, with stronger lab-testing footprint.
Broad incumbents
- Battelle: Large nonprofit R&D organization operating across health, life sciences, and national security. Overlaps with Simbex in contract medical device research, biosensors, and translational engineering; much broader portfolio.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key highlights7 records
Customer concentration
Simbex social profiles
Digital presenceSimbex compliance and trust
Trust signalCompliance1 record
Simbex financial estimates
Financial estimateRevenue estimate
Valuation estimate
Simbex leadership team
Management profileNumber of profiles
Profiles5 records
Simbex funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Simbex 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 Simbex
What does Simbex do?
Simbex provides end-to-end medical device and consumer health product design and development services, spanning mechanical and electrical engineering, software and firmware, AI/ML development, human factors design, regulatory affairs, quality systems, and commercialization strategy. The firm also develops and sells its own products, including the ActiveStep instrumented perturbation treadmill used for fall-prevention and rehabilitation research. Services are delivered as integrated, multidisciplinary engagements from ideation through regulatory submission and market launch.
Is Simbex a public or private company?
Simbex is a private company. It is classified as corporate owned and is currently operating.
When was Simbex founded?
Simbex was founded in 2004. It employs 11 to 50 people.
Where is Simbex based?
Simbex is headquartered in Lebanon, United States, in the North America region.
Who are Simbex's main competitors?
Direct peers on record are Kablooe Design, StarFish Medical, Minnetronix Medical, Product Development Technologies (PDT), Ximedica, Cambridge Consultants, Invetech and HS Design. Nelson Labs is listed as a regional player. Battelle is listed as a broad incumbent.
Does Simbex have an API?
No public API is recorded for Simbex.
What industry is Simbex in?
Simbex's product category is Medical Device Design & Development Services. Its primary akta.pro industry code is HLAGAOAH, Clinical Trial Supply, Logistics & Vendor Management FSP. Its NAICS code is 5417 and its SIC code is 8731.