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 from 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 initial 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.
* Human factors engineering support throughout the design process, including analysis, workflow assessments, and use case development.
* Services span across Diagnostics, Drug Delivery, Surgical, and Therapy Devices sectors.
**Reputation / proof points**
* Over 25 years of experience partnering with MedTech innovators.
* Multiple office locations in Canada and the United States.
StarFish Medical is a medical device design and development firm that guides innovators from 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 initial 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.
* Human factors engineering support throughout the design process, including analysis, workflow assessments, and use case development.
* Services span across Diagnostics, Drug Delivery, Surgical, and Therapy Devices sectors.
**Reputation / proof points**
* Over 25 years of experience partnering with MedTech innovators.
* Multiple office locations in Canada and the United States.
Additional information
StarFish Medical emphasizes a user-centered approach, integrating human factors engineering throughout the product development lifecycle. Their Pathfinder process aims to align commercialization, development, manufacturing, and regulatory teams, ensuring products are impactful, scalable, and meet market needs. This approach helps clients achieve peak valuation by demonstrating market traction and operational excellence. They offer support from initial ideation through to market entry and commercial readiness, focusing on de-risking the development path and building enterprise value for MedTech startups.
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 dedicated Quality Assurance and Regulatory Affairs support to navigate global requirements.
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“Navigate complexity. Accelerate approvals. Build lasting value.”
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Specializes in New Product Introduction, focusing on value creation and market validation.
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“From Innovation to Value Creation”
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Employs human factors engineering expertise for user-friendly medical device interfaces.
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“Follow these principles in UI design to develop a friendly, effective user interface.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device companies seeking end-to-end product development support.
- Innovators needing to navigate complex regulatory landscapes.
- Startups focused on value creation and market validation.
How engagement typically works
- Collaborative partnership with client teams.
- User-centered design integration.
- Strategic guidance from concept to commercialization.
Typical deliverables
- Medical device design and development plans.
- Prototypes and validation reports.
- Regulatory submission strategies and support.
- Human factors engineering analyses and reports.
Good to know
- Best when seeking a partner with deep expertise in medical device regulations and user experience.
HQ:
Victoria, Canada
Languages:
English
Timezones:
PST, MST, CST, EST, GMT, UTC
Status:
listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Canada, Asia
Industries:
Medical Devices
Usability Study Types Offered:
Formative study, Summative study
Services Offered:
Task analysis, User interface evaluation
User Types Supported:
Lay user, Professional healthcare
Use Environments Supported:
Home healthcare, Professional healthcare
Standards Supported:
IEC 62366-1, FDA Human Factors Guidance
Has Participant Recruitment:
Yes
Has Usability Lab:
No
Has Remote Testing:
No
Rush Available:
No
Nda Support:
Yes
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Summative study
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing, Regulatory strategy, Quality assurance, New product introduction, Product design and development
Standards Supported
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance, ISO 14971
User Types Supported
Lay user, Professional healthcare
Use Environments Supported
Home healthcare, Professional healthcare
Lead Time Band
Start in 0-2 weeks
Quote SLA
3-5 business days
Minimum Project Size
$50k+
Pricing Model
Custom
