Best Medical Device Development Companies

StarFish Medical

Editor's pick #1

Canadian medtech design firm with its own ISO 13485 manufacturing floor and clean room

Founded 1999 | Victoria, BC, Canada | 201–250 employees
industrial-designmechanicalelectronicsfirmwareregulatorymanufacturing

What is StarFish Medical?

StarFish Medical was founded in Victoria, British Columbia, by Scott Phillips (the company gives 1999; some directories list 1998). It works only on medical devices, covering design, development and low-volume manufacturing in ISO 13485 certified facilities, and reports around 230 staff across Victoria, Toronto and Irvine (per company website; independently unverifiable). In November 2024 it acquired Omnica Corporation, a California medical device design firm, which added a larger US West Coast presence. Victoria remains the headquarters and its largest site.

StarFish Medical works primarily with clients in Diagnostics & lab devices, Surgical & therapeutic devices, Wearables & remote monitoring, Drug delivery sectors. Its primary differentiator is: Medtech-only practice that can build clinical and early commercial units in its own certified clean room.

StarFish Medical tech stack and services

ISO 13485 QMSIEC 62304ISO 14971Embedded C/C++SolidWorksOptics & photonics
Service area
Industrial Design & Human Factors
Mechanical Engineering
Electronics & PCB Design
Firmware & Embedded Software
Regulatory & QMS Support
Manufacturing & Scale-up

StarFish Medical pricing

Short answer: StarFish Medical uses a phased fixed project, time and materials pricing approach. Minimum engagement is not publicly disclosed; a discovery call is required.

Engagement model Typical range Best for
Fixed project From not disclosed Well-defined scope
Manufacturing contract Variable; depends on team size Large programmes or team augmentation
Time & materials Variable; depends on team size Large programmes or team augmentation
StarFish Medical does not publish a public rate card. Contact them directly via their website to get project-specific pricing.

StarFish Medical pros and cons

Advantages Things to consider
+Every project is a medical device, so design reviews, risk files and documentation follow medtech practice by default -Volume manufacturing beyond pilot quantities still needs a larger contract manufacturer
+Prototype and pilot production happen in its own ISO 13485 facility, avoiding an early transfer to a contract manufacturer -North American cost base makes it more expensive than Eastern European or Asian engineering teams
+The Omnica acquisition adds Southern California capacity for US clients -The Omnica integration is recent, so cross-site processes are still settling
+Multidisciplinary teams cover industrial design, mechanics, electronics, software and human factors

StarFish Medical vs alternatives

How StarFish Medical compares to the other top Medical Device Development companies.

Company Best for Key difference Rating Compare
Lemberg Solutions Connected and smart medical devices, one engineering team. Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together 4.8 Full comparison
Sunrise Labs Electromechanical devices, fluidics and infusion. Three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled 4.5 Full comparison
Velentium Implantables and FDA cybersecurity submissions. Combines active-implantable engineering with a dedicated device cybersecurity team that prepares FDA premarket security documentation 4.5 Full comparison
Cambridge Consultants Novel technology with high technical risk. Physicists, chemists and engineers working in one building on problems no off-the-shelf design can solve 4.4 Full comparison
TTP Pharma device programs, inhalers and injectors. Employee ownership plus long-running drug delivery and surgical device work for large pharma and medtech clients 4.4 Full comparison
Zühlke European medtech firms modernizing device software. A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program 4.4 Full comparison
MedAcuity Device makers with hardware but no software team. US-based, ISO 13485 certified team that does nothing but regulated device software 4.3 Full comparison
Key Tech IVD instruments with consumables. Designs the diagnostic instrument and its cartridge together, with human factors in the same studio 4.3 Full comparison
Team Consulting Inhalers, injectors and human-factors-heavy devices. Three decades of medical-only industrial design and human factors, especially for drug delivery 4.3 Full comparison
Minnetronix Medical Electronic devices from design into US production. Develops and then manufactures electronic medical devices in the same Minnesota medtech cluster 4.3 Full comparison
Planet Innovation Diagnostics companies in Asia-Pacific and the US. Diagnostics roots plus product and commercialization experience in Australia and the US 4.2 Full comparison
Orthogonal SaMD and device companion apps. Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices 4.2 Full comparison
S3 Connected Health Pharma companies adding connectivity to drug delivery. Combines embedded wireless engineering with patient-facing apps and data platforms for pharma programs 4.2 Full comparison
Veranex Device design plus clinical trials and reimbursement. One contract can cover engineering, clinical studies, regulatory strategy and reimbursement 4.2 Full comparison
Sagentia Innovation Surgical robotics and combination products. Medical development backed by a listed science group that also runs a regulatory consultancy 4.1 Full comparison
Bluefruit Software UK device makers outsourcing firmware and testing. Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture 4.1 Full comparison
Promenade Software Small device makers needing software and security. Pairs contract device software with its own medical cybersecurity tooling and information-sharing service 4.1 Full comparison
Integrated Computer Solutions (ICS) Touchscreen user interfaces on medical devices. Qt and embedded UI depth applied to regulated device software, including on QNX 4.0 Full comparison
Delve User research and industrial design for medtech. Design research and industrial design depth from two long-established US studios 4.0 Full comparison
Kaleidoscope Innovation Enterprises already working with Infosys. US medical design studio with access to Infosys engineering and digital capacity 4.0 Full comparison
Product Creation Studio Pacific Northwest startups and lab instruments. Small ISO 13485 studio that can follow its own quality system or the client's 4.0 Full comparison
Simbex Sensor wearables and biomechanics research. Biomechanics and sensor research background applied to wearable health devices 3.9 Full comparison
Softeq Connected devices needing hardware plus apps. Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place 3.9 Full comparison
ScienceSoft SaMD and device software on a budget. Large, ISO 13485 certified software team with healthcare analytics and testing services 3.9 Full comparison
Tata Elxsi Large medtech firms offshoring sustaining engineering. Offshore scale for verification, documentation and sustaining work on existing device portfolios 3.9 Full comparison
Phillips-Medisize Drug delivery devices needing high-volume production. Design, molding and assembly of drug delivery devices under one global quality system 3.9 Full comparison
Jabil Healthcare Global production capacity for cleared devices. Global scale, supply chain and FDA-registered production for established medical device brands 3.8 Full comparison
Flex Health Solutions Design transfer into global contract manufacturing. Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network 3.8 Full comparison
Plexus Complex capital equipment needing build and sustaining. Engineering, NPI and sustaining services for low-to-mid volume, high-complexity medical equipment 3.8 Full comparison

StarFish Medical FAQ

What is StarFish Medical?

Canadian medtech design firm with its own ISO 13485 manufacturing floor and clean room

How much does StarFish Medical charge?

StarFish Medical uses phased fixed project, time and materials pricing. Minimum engagement is not publicly disclosed. A discovery call is required to get project-specific quotes.

What tech stack does StarFish Medical use?

StarFish Medical works with ISO 13485 QMS, IEC 62304, ISO 14971, Embedded C/C++, SolidWorks, Optics & photonics. Primary industries served include Diagnostics & lab devices, Surgical & therapeutic devices, Wearables & remote monitoring, Drug delivery.

Is StarFish Medical right for enterprise?

Startups needing design plus pilot manufacturing. 201–250 team size. Key consideration: Volume manufacturing beyond pilot quantities still needs a larger contract manufacturer.

What are the best StarFish Medical alternatives?

The best alternatives to StarFish Medical depend on your use case. Top options are:

  • Lemberg Solutions: owns pcb design, firmware, embedded linux, iot backend and edge ai under one roof, so device and cloud are designed together
  • Sunrise Labs: three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled
  • Velentium: combines active-implantable engineering with a dedicated device cybersecurity team that prepares fda premarket security documentation
See full alternatives list

Compare StarFish Medical with other Medical Device Development companies

Verify all details directly with StarFish Medical before making a decision.