StarFish Medical
StarFish Medical is a Canadian medical device design, development, and manufacturing services firm serving medtech startups and global enterprises across Diagnostics, Drug Delivery, Surgical, and Therapy Devices with offices in Victoria, Toronto, and Newport Beach.
- Company typePrivate
- Founded1999
- HeadquartersVictoria, Canada
- Headcount101–250
- GTM typeB2B
- OfferingServices
What StarFish Medical does
StarFish Medical (legal entity Starfish Product Engineering Inc.) is a privately held Canadian medical device design, development, and manufacturing services firm headquartered in Victoria, British Columbia, with additional offices in Toronto, Ontario and Newport Beach, California. The firm provides end-to-end support across four primary service lines — Medical Device Design & Development, New Product Introduction, and Quality Assurance and Regulatory Affairs — serving medtech startups, founders, and global enterprises in the Diagnostics, Drug Delivery, Surgical, and Therapy Devices sectors. StarFish reports 200+ multidisciplinary professionals, 25+ years of operating history, and 1,000+ completed programs, with named engagements spanning smart orthopedic implants (Canary Medical), ingestible diagnostics (Progenity), tinnitus therapy (Otoharmonics/Levo), photobiomodulation (LumiThera), portable oxygen systems (Inogen, Mallinckrodt/HELiOS), ultrasonic surgery (Misonix), insulin delivery (MiniMed/Medtronic), and prosthetics (Freedom Innovations).
The firm monetizes through project-based professional services engagements delivered under multi-year enterprise partnerships and structured startup programs (including its Pathfinder commercialization methodology), with revenue tied to the volume and duration of design, regulatory, and manufacturing transfer contracts. Differentiators include ISO 13485- and ISO 27001-certified facilities for prototyping, V&V testing, and pilot-scale manufacturing, deep expertise across FDA, EU MDR/IVDR, Health Canada, MDSAP, and QMSR regulatory frameworks, and an AI-powered regulatory research tool (ELLA) introduced in 2024. The 2023 acquisition of California-based Omnica opened the firm's first U.S. office and marked the start of a cross-border North American footprint.
StarFish Medical firmographics
Firmographics- Name
- StarFish Medical
- Legal name
- Starfish Product Engineering Inc.
- Website
- https://starfishmedical.com
- Company type
- Private
- Founded year
- 1999
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- StarFish Medical is a Canadian medical device design, development, and manufacturing services firm serving medtech startups and global enterprises across Diagnostics, Drug Delivery, Surgical, and Therapy Devices with offices in Victoria, Toronto, and Newport Beach.
- Ownership category
- akta.pro rank
StarFish Medical industry classification
Industry- Product category
- Medical Device Design & Development Services
- NAICS
- Medical Equipment and Supplies Manufacturing (3391)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Medical Device Regulators (HLAJADAC)
- akta.pro secondary industries
- Proteomics & Mass Spectrometry Services (HLAGANAB), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)
Keywords
Where StarFish Medical is headquartered
LocationHeadquarters
- HQ city
- Victoria
- HQ country
- Canada
- HQ region
- North America
Offices3 records
Markets served
StarFish Medical business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Medical Device Development Services: Full-service medical device design and development including product design, regulatory strategy, quality assurance, and new product introduction. Revenue is generated through project-based consulting and development contracts with medtech companies.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Enterprise Partnerships |
| Other | Multi-year contract | Startups & Founders |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels7 records
StarFish Medical product offering
Product offeringCore offering
StarFish Medical provides full-service medical device design, development, and manufacturing support services, taking products from concept through regulatory clearance, clinical validation, and manufacturing transfer. Core engagements include Product Design & Development, New Product Introduction with a commercial launch focus, and Quality Assurance & Regulatory Affairs across FDA, EU MDR/IVDR, Health Canada, and MDSAP pathways. The firm also offers the ELLA AI-powered regulatory research tool and tailored services across Diagnostics, Drug Delivery, Surgical, and Therapy Devices sectors.
Product overview
StarFish Medical offers a comprehensive portfolio of medical device design and development services organized around core offerings including Medical Device Design & Development, New Product Introduction (NPI), and Quality Assurance and Regulatory Affairs. Their service structure spans multiple healthcare sectors: Diagnostics (ultrasound, implantable diagnostics, ingestibles, wearable sensors), Drug Delivery (precision dosing systems, combination products), Therapy Devices (ventilators, dialysis, critical care), and Surgical (surgical platforms, instruments). ELLA is their AI-powered regulatory compliance tool that uses natural language processing for FDA regulatory research. The company operates across Canada and the U.S. with ISO-certified facilities supporting prototyping, verification testing, and pilot-scale manufacturing.
Differentiator
Problem solved
Functional benefit
Products and services
- Medical Device Design & Development Full-service medical device design and development service that brings multidisciplinary engineering, scientific expertise, and user-centered design to transform a medical device from concept to final product. Aimed at medtech innovators from startups to global enterprises.
- New Product Introduction (NPI) Medical device design and development service with a commercial launch focus, aligning commercialization, development, manufacturing, and regulatory teams around market and clinical signals to help medtech companies reach optimal valuation windows for growth, acquisition, or strategic partnership. Supports clinical trials and tech transfers to manufacturing.
- Quality Assurance and Regulatory Affairs Regulatory and quality service helping clients navigate complex regulatory landscapes including FDA, EU MDR/IVDR, Health Canada, MDSAP, QMSR, and UK pathways. Includes QMS architecture, documentation, validation, auditing, and integrated approach to quality and regulatory affairs.
- ELLA AI-powered regulatory compliance tool that uses advanced natural language processing to extract key insights from FDA databases, guidance documents, and adverse event reports. Aimed at medical device companies navigating regulatory compliance.
- Diagnostics Sector Services Design and development services for diagnostic devices including ultrasound systems, implantable diagnostics, ingestibles, wearable sensors, and AI-driven analysis platforms for modern healthcare. Targeted at companies developing diagnostic equipment, instruments, and remote diagnostic devices.
- Drug Delivery Sector Services Custom design and development services for drug delivery devices and combination products, including precision dosing, user safety, and containment integrity through validated, quality-managed systems. Targeted at companies creating drug delivery devices and combination products.
- Therapy Devices Sector Services Design and development services for therapy devices for critical care including ventilators, dialysis machines, surgical equipment, and home-based therapies, with user-centered design and reliability focus. Targeted at companies developing therapeutic devices for clinical and home-based settings.
- Surgical Sector Services Surgical device development services including next-generation integrated surgical platforms, ultrasonic surgical systems, and precision surgical instruments. Targeted at companies developing surgical instruments and platforms.
Quantifiable outcome
- 1000+ programs completed across medical device sectors
- +3 more outcomes
Companies that use StarFish Medical
Customer profileNamed customers13 records
Segments6 records
Ideal customer profiles2 records
StarFish Medical technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature3 records
StarFish Medical partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- OmnicacoreStarFish Medical acquired California-based Omnica in 2023, marking the company's first expansion into the U.S. market. This acquisition enables StarFish to serve North American clients more effectively and expand its footprint in the U.S. medtech ecosystem. The acquisition is described as a first anniversary milestone in November 2024.
Scale indicators3 records
Recent moves6 records
Expansion highlights6 records
StarFish Medical competitors and assessment
Company assessmentDirect peers
- Cambridge Consultants: Product development and engineering consultancy with a dedicated medtech practice covering diagnostics, drug delivery, and surgical devices. Comparable in delivering multidisciplinary design, regulatory, and prototyping services to medtech innovators.
- Product Creation Studio: Boutique medical device design and development consultancy focused on bringing user-centered, FDA-cleared products to market. Closely comparable to StarFish in serving startups and mid-market medtech firms with full lifecycle design services.
- Battelle Memorial Institute: Large nonprofit R&D organization with a medical device practice offering design, testing, and regulatory services. Comparable to StarFish in providing scientific, engineering, and regulatory expertise for medtech development programs.
- NAMSA: Medical-focused contract research organization providing testing, regulatory, and quality services for medical devices. Comparable to StarFish in the regulatory affairs and quality systems segments, though NAMSA leans more toward testing and clinical CRO work.
- Meddux Development Corporation: Boutique medical device design, development, and manufacturing firm serving startups and mid-sized OEMs with embedded systems and mechanical engineering. Direct comparability with StarFish in cross-functional medtech design services and pilot manufacturing.
- Velentium: U.S.-based medical device design and manufacturing firm offering embedded systems, mechanical, and regulatory services. Highly comparable to StarFish's full-stack medtech design + manufacturing + RA offering for similar startup and enterprise client profiles.
Broad incumbents
- Jabil Healthcare: Global manufacturing services giant with a sizable healthcare and medtech business spanning design services, tooling, and high-volume production. Comparable to StarFish in offering design-to-manufacturing support for medtech OEMs at much larger scale.
- Phillips-Medisize: A large medical device contract design, development, and manufacturing organization owned by Molex. Overlaps with StarFish across drug delivery, diagnostics, and combination products but operates at far greater global scale and manufacturing depth.
- Flex (Flex Medical Solutions): Global EMS provider with a dedicated medical segment offering design, engineering, regulatory, and manufacturing services. Competes with StarFish in mid-to-large enterprise medical device programs, particularly in drug delivery and diagnostics.
- Confluent Medical Technologies: Nitinol and medical device contract manufacturer with design, prototyping, and finished-device capabilities. Comparable to StarFish in offering specialized design and manufacturing for implants and combination products across cardiovascular, neurovascular, and structural heart segments.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
StarFish Medical social profiles
Digital presenceStarFish Medical compliance and trust
Trust signalCompliance6 records
StarFish Medical financial estimates
Financial estimateRevenue estimate
Valuation estimate
StarFish Medical leadership team
Management profileNumber of profiles
Profiles4 records
StarFish Medical subsidiaries and ownership
Company hierarchySubsidiaries1 record
StarFish Medical funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
StarFish Medical M&A and investment
M&A and investmentM&A2 records
Investments2 records
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about StarFish Medical
What does StarFish Medical do?
StarFish Medical provides full-service medical device design, development, and manufacturing support services, taking products from concept through regulatory clearance, clinical validation, and manufacturing transfer. Core engagements include Product Design & Development, New Product Introduction with a commercial launch focus, and Quality Assurance & Regulatory Affairs across FDA, EU MDR/IVDR, Health Canada, and MDSAP pathways. The firm also offers the ELLA AI-powered regulatory research tool and tailored services across Diagnostics, Drug Delivery, Surgical, and Therapy Devices sectors.
Is StarFish Medical a public or private company?
StarFish Medical is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was StarFish Medical founded?
StarFish Medical was founded in 1999. It employs 101 to 250 people.
Where is StarFish Medical based?
StarFish Medical is headquartered in Victoria, Canada, in the North America region.
How does StarFish Medical make money?
One revenue line is on record: medical Device Development Services.
Who are StarFish Medical's main competitors?
Direct peers on record are Cambridge Consultants, Product Creation Studio, Battelle Memorial Institute, NAMSA, Meddux Development Corporation and Velentium. Broad incumbents are Jabil Healthcare, Phillips-Medisize, Flex (Flex Medical Solutions) and Confluent Medical Technologies.
Does StarFish Medical have an API?
No public API is recorded for StarFish Medical.
What industry is StarFish Medical in?
StarFish Medical's product category is Medical Device Design & Development Services. Its primary akta.pro industry code is HLAJADAC, Medical Device Regulators, with a secondary code of HLAGANAB, Proteomics & Mass Spectrometry Services. Its NAICS code is 3391 and its SIC code is 3841.