StarFish Medical

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.

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

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

• Medical device design
• Regulatory affairs consulting
• Product development services
• Quality management systems
• Drug delivery devices

Headquarters

HQ city

Victoria

HQ country

Canada

HQ region

North America

Offices3 records

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 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

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core 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

Named customers13 records

Segments6 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Partnerships

One partnership is on record.

• OmnicacoreOthers · 1 January 2023StarFish 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

Direct 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

• YouTubeyoutube.com/starfishmedical
• LinkedInlinkedin.com/company/starfish-medical
• Xx.com/starfishmedical
• Facebookfacebook.com/StarFishMedical

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments2 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about StarFish Medical