StarFish Medical
StarFish Medical is a leading medical device design and development firm. They offer comprehensive services from concept to commercialization, focusing on user-centered design and regulatory compliance to bring innovative MedTech products to market.
StarFish Medical empowers MedTech innovation by blending deep technical expertise, regulatory insight, and user-centered design to bring breakthrough products to life. They specialize in guiding medical device companies through every stage of the development process, from initial concept to high-volume production, ensuring safety, efficacy, and compliance. Their multidisciplinary teams provide comprehensive support for medical device design and development, new product introduction, and quality assurance and regulatory affairs. StarFish Medical helps startups and established companies navigate complex regulatory landscapes, transform visionary ideas into market-ready products, and achieve commercial success. They emphasize a user- and patient-centric approach, ensuring designs are grounded in real-world needs and clinical workflows. With a focus on commercial launch and value creation, StarFish Medical aligns market validation and financial opportunity. They help clients identify optimal commercialization paths, de-risk technical challenges, and build scalable businesses around innovative devices. Their services are designed to accelerate product development, ensuring impactful, scalable products that meet real market needs and investor expectations.
About
**Who they are**
StarFish Medical is a medical device design and development firm that guides innovators through the complex journey from initial concept to commercial launch. They focus on user-centered design and regulatory compliance to bring MedTech products to market.
**Expertise & scope**
* Comprehensive medical device design and development services, from concept to final product.
* Expertise in user- and patient-centric design, ensuring products meet user needs and market demands.
* Services include rapid prototyping, verification, validation, and clinical prototypes.
* Specialized support for new product introduction, focusing on market validation and value creation.
* Guidance on regulatory strategy, gap analysis, and engagement with regulatory bodies.
* Quality assurance and regulatory affairs support to navigate global requirements and build robust quality systems.
* Technology transfer and manufacturing scale-up assistance.
* Program management throughout the development lifecycle.
**Reputation / proof points**
* Over 25 years of experience partnering with MedTech innovators.
* Offices located in Victoria, Toronto, and Irvine, United States.
StarFish Medical is a medical device design and development firm that guides innovators through the complex journey from initial concept to commercial launch. They focus on user-centered design and regulatory compliance to bring MedTech products to market.
**Expertise & scope**
* Comprehensive medical device design and development services, from concept to final product.
* Expertise in user- and patient-centric design, ensuring products meet user needs and market demands.
* Services include rapid prototyping, verification, validation, and clinical prototypes.
* Specialized support for new product introduction, focusing on market validation and value creation.
* Guidance on regulatory strategy, gap analysis, and engagement with regulatory bodies.
* Quality assurance and regulatory affairs support to navigate global requirements and build robust quality systems.
* Technology transfer and manufacturing scale-up assistance.
* Program management throughout the development lifecycle.
**Reputation / proof points**
* Over 25 years of experience partnering with MedTech innovators.
* Offices located in Victoria, Toronto, and Irvine, United States.
Additional information
StarFish Medical emphasizes a holistic approach, integrating design, development, regulatory affairs, and quality assurance from the outset. Their Pathfinder process is designed to align commercialization, development, manufacturing, and regulatory teams, ensuring products are impactful, scalable, and meet real market needs. This integrated strategy aims to guide clients toward peak valuation by aligning market traction and operational excellence, creating options for growth, acquisition, or strategic partnership. They work closely with client teams to define products from every angle, ensuring feasibility, fundability, and commercial success.
Key Highlights
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Offers comprehensive medical device design and development from concept to commercialization.
Source
“Custom medical device design and development from concept to final product”
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Provides specialized support for New Product Introduction, focusing on market validation and value creation.
Source
“At StarFish, we help innovators move from product validation to value creation.”
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Expertise in Quality Assurance and Regulatory Affairs to navigate global requirements and accelerate approvals.
Source
“Navigate complexity. Accelerate approvals. Build lasting value.”
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Has over 25 years of experience partnering with MedTech innovators.
Source
“For more than 25 years, StarFish Medical has partnered with MedTech innovators”
Certifications & Trust Signals
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Operates with offices in Victoria, Toronto, and Irvine, United States.
Source
“455 Boleskine RoadVictoria, BC V8Z 1E7, Canada 139 Mulock AveToronto, ON M6N 3C5, Canada 15560-D Rockfield Blvd.Irvine, CA 92618, United States”
Buyer Snapshot
Best for
- Companies seeking end-to-end medical device design and development.
- Innovators needing regulatory strategy and quality assurance support.
- Startups focused on value creation and market validation.
How engagement typically works
- Collaborative partnership, working closely with client teams.
- Integrated support across the entire product lifecycle.
- Guidance from concept to commercial launch.
Typical deliverables
- Market-ready medical device designs.
- Prototypes for verification and validation.
- Regulatory submission strategies and support.
- Quality management systems.
- Commercialization roadmaps.
Good to know
- Best when seeking a partner with deep expertise in medical device regulations and user-centered design.
- Ideal for projects requiring a comprehensive approach from ideation through to market entry.
Pricing
Model:
Custom pricing
HQ:
Victoria, Canada
Languages:
English
Timezones:
PST, MST, CST, EST, GMT, UTC
Claim status:
Listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Canada, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Usability Study Types Offered:
Both
Services Offered:
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing
User Types Supported:
Lay user, Professional healthcare
Use Environments Supported:
Home healthcare, Professional healthcare
Standards Supported:
IEC 62366-1, FDA Human Factors Guidance, ISO 14971
Has Participant Recruitment:
Yes
Has Usability Lab:
Yes
Has Remote Testing:
Yes
Rush Available:
Yes
Nda Support:
Yes
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Minimum Project Size:
$50k+
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Summative study
Services Offered
User interface evaluation, Instructions evaluation, Validation testing
Standards Supported
IEC 62366-1, FDA Human Factors Guidance
User Types Supported
Both
Use Environments Supported
Both
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Minimum Project Size
$50k+
Pricing Model
Custom
