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 commercialization. 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.
* Rapid prototyping and verification/validation for clinical prototypes.
* Regulatory strategy development, gap analysis, and engagement with regulatory bodies.
* New product introduction, focusing on market validation, value creation, and smooth transitions to manufacturing.
* Quality assurance and regulatory affairs support to navigate global requirements and build robust quality systems.
* Technology transfer and manufacturing scale-up guidance.
* Program management throughout the product lifecycle.
**Reputation / proof points**
* Over 25 years of experience partnering with MedTech innovators.
* Offices located in Victoria, Toronto, and Irvine.
StarFish Medical is a medical device design and development firm that guides innovators through the complex journey from initial concept to commercialization. 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.
* Rapid prototyping and verification/validation for clinical prototypes.
* Regulatory strategy development, gap analysis, and engagement with regulatory bodies.
* New product introduction, focusing on market validation, value creation, and smooth transitions to manufacturing.
* Quality assurance and regulatory affairs support to navigate global requirements and build robust quality systems.
* Technology transfer and manufacturing scale-up guidance.
* Program management throughout the product lifecycle.
**Reputation / proof points**
* Over 25 years of experience partnering with MedTech innovators.
* Offices located in Victoria, Toronto, and Irvine.
Additional information
StarFish Medical emphasizes a user-centered approach, integrating design and development with a strong focus on regulatory compliance and market readiness. Their Pathfinder process aims to align commercialization, development, manufacturing, and regulatory teams, ensuring products are impactful, scalable, and meet real market needs. This integrated strategy helps clients navigate the complexities of bringing medical devices to market, from initial ideation through to commercial launch and value creation. They work closely with clients 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 commercial launch.
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“Custom medical device design and development from concept to final product”
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Provides extensive Quality Assurance and Regulatory Affairs support, including strategy, gap analysis, and regulatory engagement.
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“Navigate complexity. Accelerate approvals. Build lasting value.”
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Focuses on user- and patient-centric design to ensure products meet user needs and market expectations.
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“User- and Patient-Centric Medical Device Design”
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Has over 25 years of experience partnering with MedTech innovators.
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“For more than 25 years, StarFish Medical has partnered with MedTech innovators”
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Supports New Product Introduction with a focus on market validation and value creation.
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“From Innovation to Value Creation”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking end-to-end medical device design and development.
- Innovators needing guidance through regulatory pathways and market entry.
- Startups and established firms requiring robust quality assurance and regulatory affairs support.
How engagement typically works
- Collaborative partnership, working closely with client teams.
- Integrated support across all development stages.
- Guidance from concept to commercialization.
Typical deliverables
- Medical device design and development plans.
- Prototypes and validation documentation.
- Regulatory strategies and submission support.
- Market validation and commercialization plans.
Good to know
- Best when a comprehensive, user-centered approach to medical device development is required.
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:
Formative study, Summative study, Both
Services Offered:
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing
User Types Supported:
Lay user, Professional healthcare, Both
Use Environments Supported:
Home healthcare, Professional healthcare, Both
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
