What Archimedic does

Archimedic is a medical device development services firm founded in 2009 and headquartered in West Chester, Pennsylvania. The company provides integrated design, engineering, regulatory, and go-to-market services to medical device developers, serving both early-stage MedTech startups and established manufacturers across therapeutic categories including diagnostics, cardiology, orthopedics, women's health, and digital health. Its core offering combines human-factors-aware mechanical and electrical design with regulatory submission support (FDA, CE Mark, ISO 13485) and downstream commercialization strategy, enabling clients to move from concept through market clearance under a single engagement.

Archimedic's technology foundation is its ISO 13485-certified, phase-based development process refined over more than 100 projects across 15+ years. In March 2025 the company extended this foundation with the launch of OpenQMS, a free quality management system platform offered to the broader MedTech development community as both a standalone tool and an ecosystem entry point into Archimedic's paid services.

The business model is project-based professional services with engagements structured around the company's phase-gated development framework, supplemented by regulatory consulting and commercialization advisory. Customer evidence is concentrated among venture-backed startups (Podimetrics, Tango, TellBio, ZSX Medical, HDM) and academic medical centers (Boston Children's, Children's National, Thomas Jefferson, PeriCor), with website presence of larger life-sciences logos (Pfizer, Johnson & Johnson, West Pharmaceutical) suggesting some enterprise exposure. The firm operates with 11–50 employees and has been through a recent leadership transition in September 2024, bringing in M. Alexander Shaw as CEO while founder Eric Sugalski moved to CTO; a CIO was added in September 2026 to support organizational scaling.

Name

Archimedic

Legal name

Archimedic, Inc.

Website

https://archimedic.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Archimedic is a West Chester, PA-based medical device development services firm that provides integrated design, regulatory, and go-to-market support to MedTech startups and established manufacturers, using an ISO 13485-certified phase-based process.

Ownership category

akta.pro rank

Headquarters

HQ city

Waltham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Medical Device Design Services: Project-based professional services for medical device design and development. Engagements cover the full product development lifecycle from concept through manufacturing transfer. Revenue generated through consulting fees and project contracts.
2. Regulatory Affairs Services: Regulatory strategy and submission support services. Includes FDA interaction preparation, 510(k) strategy, de novo pathway guidance, and regulatory submission documentation.
3. Go-to-Market Strategy Services: Commercial strategy and market adoption services. Includes market research, payer strategy, value analysis, and commercialization planning.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

Archimedic provides outsourced medical device product development services spanning industrial design, electromechanical engineering, prototyping, regulatory strategy and submission support, and go-to-market commercialization planning. Engagements cover the full device lifecycle from concept and user needs capture through design verification, validation, and manufacturing transfer, delivered under an ISO 13485 certified phase-gated process for clients in drug delivery, surgical, diagnostic, and home health categories.

Product overview

Archimedic is a medical device development firm offering an integrated portfolio of services across three core areas: Design (industrial design, electromechanical engineering, prototyping), Regulatory (strategy and submission support), and Go-To-Market (market adoption and commercialization strategy). The company supports its service offerings with complementary free resources including OpenQMS (24 downloadable QMS templates) and a Medical Device Development Process Video Series. Since 2009, Archimedic has helped develop drug delivery, surgical, diagnostic, and home health medical devices across multiple client partnerships including work on CPAP devices, laparoscopic surgical tools, diagnostic systems, wearable health monitors, and drug delivery platforms.

Differentiator

Problem solved

Functional benefit

Brands

• OpenQMS: An open-access, web-based platform providing free downloadable medical device QMS templates, forms, and video tutorials covering documentation needed for medical device development and quality compliance.

Products and services

• Medical Device Design Services Comprehensive medical device design services including industrial design, electromechanical engineering, prototyping, and testing for surgical, drug delivery, diagnostic, and home health devices. Engagements are project-based and delivered under an ISO 13485 certified development process.
• Regulatory Affairs Services Regulatory strategy and submission support including FDA interactions, 510(k) pathway strategy, De Novo guidance, PMA submissions, and international regulatory compliance for medical device companies.
• Go-to-Market Services Market adoption and commercialization strategy services to drive successful market entry for medical devices, including clinical strategy, payer strategy, healthcare economics, and value analysis.
• OpenQMS Platform Open-access web-based platform offering 24 downloadable quality management system templates and video tutorials for medical device development, covering design control, risk management, human factors, and manufacturing transfer documentation.

Quantifiable outcome

• Over 15 years of medical device development experience since 2009
• +1 more outcomes

Named customers8 records

Segments2 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• Open MedicalminorStrategic or Co-development Partner · 1 January 2020Non-profit organization focused on open-sourced medical products for patients and providers with urgent, unmet medical needs. Originated from Archimedic's COVID-19 origami mask collaboration. Archimedic team members used the mask project as launching pad for this 501c3 organization addressing underserved patient populations such as pediatrics and rare diseases.

Scale indicators2 records

Recent moves8 records

Expansion highlights4 records

Direct peers

• Veranex (formerly Ximedica): Veranex is a MedTech-focused services platform offering integrated design, engineering, regulatory, clinical, and manufacturing services. It is the closest direct competitor to Archimedic in terms of bundled device development services for both startups and established OEMs.
• StarFish Medical: StarFish Medical is a Canadian MedTech design, engineering, and contract manufacturing firm that takes clients from concept through commercialization. It mirrors Archimedic's full-lifecycle service offering across surgical, diagnostic, and therapeutic device categories.
• MCRA: MCRA is a medical device-focused regulatory, clinical, and quality services firm supporting FDA submissions, clinical trials, and post-market activities. It overlaps with Archimedic's regulatory affairs service line and shares the same MedTech startup and OEM client base.
• Sagentia Innovation: Sagentia is a product innovation and technology consultancy with deep MedTech, diagnostics, and life sciences capabilities. It competes for the same integrated design and development engagements that Archimedic pursues, particularly in regulated devices and diagnostics.
• Worrell: Worrell is a design and innovation firm focused on healthcare and medical device product development from industrial design through commercialization. It competes directly with Archimedic on the design side of the MedTech services stack.
• Insight Product Development: Insight Product Development provides integrated design, engineering, and prototyping services for medical devices and complex consumer health products. It is highly comparable to Archimedic's electromechanical and industrial design capabilities for regulated devices.
• Kablooe Design: Kablooe Design is a medical device design and development firm specializing in human factors, industrial design, and design control documentation. It competes with Archimedic for early-stage MedTech design and human factors work.
• MindFlow Design: MindFlow Design is an industrial design and engineering consultancy focused on medical devices and healthcare products. It is comparable to Archimedic on the user-centered industrial design and prototyping portion of the MedTech value chain.

Broad incumbents

• Cambridge Consultants: Cambridge Consultants is a large technology and product development consultancy with a significant MedTech and life sciences practice. It is a broader incumbent that competes for high-complexity device innovation work alongside niche players like Archimedic.
• TTP plc: TTP is a technology and product development consultancy that creates medical devices, diagnostics, and life sciences instruments for global clients. It operates as a larger-scale incumbent that overlaps with Archimedic on integrated MedTech design and development mandates.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 Archimedic