StarFish Medical
StarFish Medical is a leading provider of medical device design, development, and manufacturing solutions with over 25 years of experience. They blend deep technical expertise, regulatory insight, and user-centered design to bring MedTech innovation to life, transforming visionary ideas into breakthrough products that improve health and save lives. They serve startups to global enterprises, offering full-service design, low-volume manufacturing, and proprietary processes like Pathfinder™ to ensure precise product definition. Their facilities are ISO 13485 certified with class 10,000 clean rooms, supporting rapid prototyping, V&V testing, and pilot-scale manufacturing.
Industries
Nr. of Employees
medium (51-250)
StarFish Medical
Victoria, British Columbia, Canada, North America
Products
Aurora DNA sample preparation device
Case-study device implementing electrophoretic DNA concentration for sample preparation workflows.
Axolotl BrainPrint microsphere generator (case study)
Case study describing a microsphere generator used in 3D bioprinting applications.
Winnipeg Ventilator 2.0 (case study)
Case-study ventilator device developed for emergency and critical care applications.
Progenity ingestible capsule (case study)
Case study of an ingestible capsule platform for diagnostic or monitoring applications.
Aurora DNA sample preparation device
Case-study device implementing electrophoretic DNA concentration for sample preparation workflows.
Axolotl BrainPrint microsphere generator (case study)
Case study describing a microsphere generator used in 3D bioprinting applications.
Winnipeg Ventilator 2.0 (case study)
Case-study ventilator device developed for emergency and critical care applications.
Progenity ingestible capsule (case study)
Case study of an ingestible capsule platform for diagnostic or monitoring applications.
Services
Multidisciplinary medical device engineering from concept through prototype and design verification to support regulatory and commercial objectives.
Services to prepare devices for manufacturing and commercial launch including DFM, supply chain development, vendor qualification, and manufacturing transfer.
Regulatory strategy, submission preparation, QMS design and implementation, mock audits, and regulatory readiness support for US, EU, and Canadian markets.
AI/NLP-based tool to search and rank FDA guidance, advisory materials, and adverse event reports to accelerate regulatory research and pathway selection (510(k), De Novo, PMA).
In-house prototyping, custom test rigs (e.g., drop testers), verification & validation testing, and pilot-scale production in ISO 13485 environments.
Analytical chemistry, microbiology, and human compatibility testing to support materials selection, sterilization decisions, and regulatory submissions.
Multidisciplinary medical device engineering from concept through prototype and design verification to support regulatory and commercial objectives.
Services to prepare devices for manufacturing and commercial launch including DFM, supply chain development, vendor qualification, and manufacturing transfer.
Regulatory strategy, submission preparation, QMS design and implementation, mock audits, and regulatory readiness support for US, EU, and Canadian markets.
AI/NLP-based tool to search and rank FDA guidance, advisory materials, and adverse event reports to accelerate regulatory research and pathway selection (510(k), De Novo, PMA).
In-house prototyping, custom test rigs (e.g., drop testers), verification & validation testing, and pilot-scale production in ISO 13485 environments.
Analytical chemistry, microbiology, and human compatibility testing to support materials selection, sterilization decisions, and regulatory submissions.
Expertise Areas
- Medical device design and development
- New product introduction (NPI) and manufacturing transfer
- Regulatory strategy and submissions (US, EU, Canada)
- Quality management systems (QMS) implementation
Key Technologies
- AI/NLP for regulatory research and adverse event mining
- Embedded microcontroller firmware (Cortex-M)
- PCB design including flexi-rigid and multilayer boards
- Microfluidic cartridges and lab-on-chip platforms
News & Updates
Olfactory drug delivery offers a promising route for direct access to the central nervous system.
Medical Device Playbook Newport Beach 2025 set a new benchmark, bringing together the most senior and engaged group of leaders in the event’s history.
A new study co-authored by Nick Allan, StarFish Medical Bio Services Manager, and published in Scientific Reports highlights how device design can make or break intranasal RNA delivery.
Human compatibility testing can feel like navigating a maze. One small design change can lead to unexpected testing requirements in completely different areas.
StarFish Medical is bringing its flagship executive forum, Medical Device Playbook, back to Newport Beach, California, on May 22, 2025.
Drug delivery implants are changing how medication is administered by enabling site-specific, long-term therapeutic release.
Olfactory drug delivery offers a promising route for direct access to the central nervous system.
Medical Device Playbook Newport Beach 2025 set a new benchmark, bringing together the most senior and engaged group of leaders in the event’s history.
A new study co-authored by Nick Allan, StarFish Medical Bio Services Manager, and published in Scientific Reports highlights how device design can make or break intranasal RNA delivery.
Human compatibility testing can feel like navigating a maze. One small design change can lead to unexpected testing requirements in completely different areas.
StarFish Medical is bringing its flagship executive forum, Medical Device Playbook, back to Newport Beach, California, on May 22, 2025.
Drug delivery implants are changing how medication is administered by enabling site-specific, long-term therapeutic release.