What Omnica does

Omnica Corporation was a medical device design and engineering firm headquartered in Irvine, California, founded in 1984 by Rex Bare and Earl Robinson. The firm provided full-service medical product development spanning industrial design, hardware, firmware, software, optical systems, and human factors engineering, operating from a 25,000-square-foot facility in Orange County's MedTech corridor. Its core service offering encompassed multidisciplinary device development from early concept and product definition (via its proprietary Pathfinder Process) through prototyping, regulatory strategy (FDA 510(k), De Novo, PMA, and ISO 13485-aligned QMS), design for manufacturing, pilot builds, and transfer to contract manufacturing organizations. Named engagements included Izotropic's breast CT system, Zephyr Sleep Technologies' MATRx plus at-home sleep apnea diagnostic, LumiThera's Valeda light delivery system, SpinaFX Medical's minimally invasive treatment platform, and Biolux Research's OrthoPulse bone regeneration device.

Omnica monetized through professional services on a quote-based, project-by-project model, targeting two primary segments: venture-backed medtech startups needing concept-to-prototype execution aligned with fundraising milestones, and enterprise medical device companies seeking external regulatory and engineering capacity. Distribution was primarily direct enterprise field sales supported by thought-leadership channels including industry publications (MPO, MDDI, ODT), the Medical Device Playbook executive forum, the MedTech Insights newsletter, and ecosystem partnerships with Octane and DeviceAlliance in Southern California.

In November 2024, Omnica was acquired by StarFish Medical, a Canadian medical device development firm, and rebranded as StarFish Medical West. The acquisition integrated Omnica's 40-year design legacy and Irvine facility into StarFish's North American platform of 100+ engineers, regulatory experts, and commercialization strategists, positioning California as a key U.S. market for the combined entity. Following the acquisition, Omnica ceased operating as an independent entity and now functions as the U.S. development hub within StarFish Medical's broader portfolio.

Name

Omnica

Legal name

Omnica Corporation

Website

https://omnica.com

Company type

Private

Founded year

1984

Operating status

Acquired

Headcount range

11–50 employees

Short description

Omnica Corporation, founded in 1984 in Irvine, CA, was a medical device design and engineering firm providing full-service product development from concept through manufacturing for medtech startups and enterprises. Acquired by StarFish Medical in November 2024 and now operates as StarFish Medical West.

Ownership category

akta.pro rank

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Medical Device Design & Development Services: Full-service medical device design and development from early concept through to manufacturing handoff, including multidisciplinary integration of hardware, firmware, software, and optical systems.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Omnica was a medical device design and engineering firm providing multidisciplinary integration of hardware, firmware, software, and optical systems from early concept through manufacturing transfer. Services spanned human factors engineering, design for manufacturing, regulatory strategy aligned with FDA and ISO 13485, pilot builds and CMO transfer, and commercialization alignment for venture-backed startups and large medical device companies.

Product overview

Omnica (now operating as StarFish Medical Irvine) offers comprehensive medical device design and development services rather than a discrete software product. Following its acquisition by StarFish Medical in November 2024, Omnica's service offering integrates with StarFish Medical's broader portfolio including Medical Device Design & Systems Engineering, Human Factors Engineering & Usability Testing, Design for Manufacturing, Medical Device Manufacturing Support, Regulatory Strategy & Quality Systems, and Commercialization & Business Alignment. The company supports medical devices across a wide spectrum including surgical tools, diagnostics, wearables, imaging platforms, and energy-based therapeutics.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Design & Systems Engineering Multidisciplinary integration of hardware, firmware, software, and optical systems developed to meet regulatory, clinical, and business requirements for medical device clients.
• Human Factors Engineering & Usability Testing Embedded human factors support ensuring user-centered design and compliance with FDA and international usability standards for medical device clients.
• Design for Manufacturing (DFM) Engineering for manufacturability from the start, supporting component selection, cost analysis, and vendor alignment for scalable medical device production.
• Medical Device Manufacturing Support Pilot builds, comprehensive documentation generation, and device preparation for seamless transfer to contract manufacturing organizations (CMOs).
• Regulatory Strategy & Quality Systems FDA and ISO 13485-aligned development, design controls, and submission support integrated throughout the medical device product lifecycle, including 510(k), De Novo, and PMA submissions.
• Commercialization & Business Alignment Support for venture-backed startups and growth-stage companies in aligning technical execution with investment, market entry, and partnership strategies.

Named customers5 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Two partnerships are on record, tiered minor.

• OctaneminorGTM or Marketing PartnerPartnership with Octane for accelerating growth and investment in high-impact medtech ventures. Octane connects medtech innovators in Orange County's MedTech corridor with resources and support.
• DeviceAllianceminorGTM or Marketing PartnerPartnership with DeviceAlliance connecting Orange County's medical device professionals and fostering leadership and professional development in the local medtech ecosystem.

Scale indicators2 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• RBC Medical Innovations: RBC Medical Innovations is a medical device design and development firm offering product engineering, prototyping, and manufacturing support to OEMs and startups, comparable in scope and customer mix to Omnica.
• Sagentia Innovation: Sagentia Innovation is a science and engineering consultancy providing medical device design, development, and regulatory support across diagnostics, surgical, and therapeutic devices, with comparable multidisciplinary capabilities.
• MindFlow Design: MindFlow Design is an industrial design and engineering firm specializing in medical device, diagnostic, and consumer health product development, with an industrial design emphasis similar to Omnica's heritage.
• Sunrise Labs: Sunrise Labs is a medical device engineering services firm offering embedded systems, software, hardware, and full product development support, directly comparable to Omnica's hardware/firmware/software integration practice.
• Invetech: Invetech provides product design, engineering, and manufacturing services for medical devices, diagnostics, and IVD products. Its integrated design-to-manufacturing model and medtech focus make it a close functional peer to Omnica.
• Veranex (formerly Ximedica): Veranex is a full-service medical device design, development, and commercialization services firm with multidisciplinary engineering, human factors, regulatory, and manufacturing transfer capabilities that closely mirror Omnica's end-to-end service offering.
• MEDIcept (formerly Sterling Medical Devices): MEDIcept provides medical device software, hardware, regulatory, and quality systems services to medtech companies, closely aligning with Omnica's integrated engineering and regulatory offerings.

Broad incumbents

• Cambridge Consultants: Cambridge Consultants is a large technology and engineering consultancy with a dedicated medical device division offering product innovation, regulatory strategy, and design services that overlap materially with Omnica's offering, though it spans multiple industries.
• StarFish Medical: StarFish Medical is a Canadian medical device design, development, and manufacturing services firm that acquired Omnica in November 2024. It is now Omnica's parent and operates the same Irvine site, making it the most direct operational comparable.

Emerging players

• Aran Biomedical: Aran Biomedical is a medical device design, development, and biomaterial components firm offering device engineering and pilot manufacturing for implantables and minimally invasive devices, with overlapping but narrower capabilities than Omnica.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

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 Omnica