# StarFish Medical: StarFish Medical provides medical device development services ranging from strategic planning and technology development through to engineering, manufacturing and regulatory support\.

> StarFish Medical \- Empowering MedTech innovation to create breakthrough products that improve health and save lives\.

Generated by Yoast SEO v28.7, this is an llms.txt file, meant for consumption by LLMs.

## Pages
- [Medical Device Development, Manufacturing \& QA/RA](https://starfishmedical.com/services/)
- [Careers](https://starfishmedical.com/careers/)
- [Medical Device Manufacturing Scale\-Up](https://starfishmedical.com/services/manufacturing/medical-device-manufacturing-scale-up/)
- [Medical Device Design Transfer \& Manufacturing Readiness](https://starfishmedical.com/services/manufacturing/medical-device-design-transfer-manufacturing-readiness/)
- [Medical Device Clinical Manufacturing Services](https://starfishmedical.com/services/manufacturing/medical-device-clinical-manufacturing-services/)
- [Medical Device Manufacturing](https://starfishmedical.com/services/manufacturing/)
- [Startups \& Founders](https://starfishmedical.com/working-with-starfish/startups-founders/)
- [Enterprise Partnerships](https://starfishmedical.com/working-with-starfish/enterprise-partnerships/)
- [Working with StarFish Overview](https://starfishmedical.com/working-with-starfish/working-with-starfish-overview/)
- [Therapy Devices](https://starfishmedical.com/sectors/therapy-devices/)
- [Drug Delivery](https://starfishmedical.com/sectors/drug-delivery/)
- [Diagnostics](https://starfishmedical.com/sectors/diagnostics/)
- [Quality Assurance and Regulatory Affairs](https://starfishmedical.com/services/quality-assurance-regulatory-affairs/)
- [Medical Device Design \& Development](https://starfishmedical.com/services/medical-device-design-and-development/)
- [Case Studies](https://starfishmedical.com/case-studies/)
- [About StarFish Medical](https://www.starfishmedical.com/about-starfish-medical/)
- [Leadership](https://www.starfishmedical.com/leadership/)
- [Meet ELLA](https://www.starfishmedical.com/meet-ella/)
- [Drug Delivery Strategy Guide](https://www.starfishmedical.com/drug-delivery-strategy-guide/)

## Case Studies
- [Winnipeg Ventilator 2\.0](https://www.starfishmedical.com/case-study/winnipeg-ventilator-2/)
- [Canary Medical: From Concept to Smart Implant Prototype](https://starfishmedical.com/case-study/smart-implantable-screw-fracture-monitoring/): StarFish Medical helped Canary Medical develop a smart implantable screw using EIS to monitor fracture healing without repeated imaging\.
- [LumiThera: From Prototype to Commercial Medical Device](https://starfishmedical.com/case-study/lumithera/): LumiThera chose StarFish Medical for their expertise in navigating the path from late\-stage prototype to commercial launch\. 
- [Transforming Cancer Treatment through Innovative Technology \& Design](https://starfishmedical.com/case-study/transforming-cancer-treatment-through-innovative-technology-design/): Theranostics represent a promising new frontier in cancer treatment, offering hope alongside a unique set of challenges for healthcare providers\.
- [Enabling Safe, Targeted Delivery of ALS Cell Therapy](https://starfishmedical.com/case-study/cns-cell-therapy-delivery/): A leading research institution tackling the challenge of motor neuron degeneration in ALS developed a novel approach to treatment: deliver GDNF\-secreting neural progenitor cells directly into the spinal cord to provide sustained neurotrophic support\.

## Events
- [Grand Challenges in Neuroscience](https://starfishmedical.com/event/grand-challenges-in-neuroscience/): In this on\-demand recording of "Grand Challenges in Neuroscience" from January 21, 2025, Dr\. Jacob Hooker, Lurie Family Professor of Radiology and Scientific Director at the Lurie Center for Autism at Massachusetts General Hospital, joins Nick Allan, Bio Services Manager at StarFish Medical, to discuss some of the biggest hurdles in neuroscience today\. The conversation explores the complex interplay between chemistry, biology, and medical device engineering, offering insights into the latest innovations in neurotherapeutics, molecular imaging, and non\-invasive drug delivery technologies\.
- [Hardware to Intelligence: Building a Reimbursement Strategy for Intelligent Medical Devices](https://starfishmedical.com/event/medtech-reimbursement-strategy-webinar/): In this MedTech Unscripted, Hardware to Intelligence: Building a Reimbursement Strategy for Intelligent Medical Devices, Scott Phillips sits down with Dr\. Bill Hunter\.
- [Built for Exit: What Drives MedTech Success](https://www.starfishmedical.com/event/medtech-exit-strategy-webinar/)
- [From Founder  to Builder CEO \- Clarius](https://www.starfishmedical.com/event/from-founder-ceo-to-builder-ceo/): From Founder CEO to Builder CEO, Laurent Pelissier and Ohad Arazi share the swashbuckling tale of Clarius\.
- [Medical Device Playbook Newport Beach 2026](https://www.starfishmedical.com/event/medical-device-playbook-newport-beach-2026/): Medical Device Playbook returns to Newport Beach on May 21, 2026, bringing together MedTech founders, CEOs, investors, and senior industry leaders\.

## News
- [StarFish Medical Announces Medical Device Playbook Newport Beach 2025](https://www.starfishmedical.com/news/starfish-medical-announces-medical-device-playbook-newport-beach-2025/): Victoria, BC, and Newport Beach, CA — April 7, 2025 — StarFish Medical is bringing its flagship executive forum, Medical Device Playbook, back to Newport Beach, California, on May 22, 2025\. This invitation\-only event arrives at a pivotal moment for MedTech leaders, as regulatory frameworks shift and markets remain unpredictable\.
- [2015 Medical Device Commercialization Playbook in Vancouver BC on April 1](https://starfishmedical.com/news/2015-medical-device-commercialization-playbook-april-1-2015/)
- [StarFish Medical Hosts MedTech Unscripted on Building a Reimbursement Strategy for Intelligent Medical Devices](https://starfishmedical.com/news/reimbursement-strategy-intelligent-medical-devices/): StarFish Medical today announced an upcoming MedTech Unscripted, Hardware to Intelligence: Building a Reimbursement Strategy for Intelligent Medical Devices\.
- [StarFish Medical Receives $620,000 in Federal Funding to Advance AI Integration in Medical Device Development](https://www.starfishmedical.com/news/starfish-medical-federal-ai-funding-medical-device-development/): StarFish Medical has received a repayable contribution of $620,000 from Pacific Economic Development Canada \(PacifiCan\) under the Regional Artificial Intelligence Initiative to accelerate the integration of artificial intelligence into its medical device design and development programs\.
- [StarFish Medical Hosts MedTech Unscripted on Building MedTech Companies for Exit](https://www.starfishmedical.com/news/medtech-exit-strategy-event/): Built for Exit brings together StarFish Medical CEO Scott Phillips and diagnostics pioneer Mickey Urdea for a candid discussion on value creation and commercial outcomes

## Resources
- [When do Startups Need a Quality Management System \(QMS\)?](https://starfishmedical.com/resource/when-do-you-need-a-quality-management-system-qms/): Advice to help companies determine when to start thinking about setting up a Startup Quality Management System\. 
- [Strategies to Maximize Outcomes During Pre\-Submission Meetings](https://starfishmedical.com/resource/strategies-to-maximize-outcomes-during-pre-submission-meetings/): Strategies to maximize outcomes for interactions during regulatory pre\-submission meetings using 4 simple, but effective steps\.
- [ALARP to AFAP, the MDR and ISO 14971:2019\+A11:2021](https://starfishmedical.com/resource/medical-device-risk-management-and-the-change-from-alarp-to-afap/): When it comes to risk, the first thing to consider is the ISO 14971 standard\. MDR and IVDR changes bring a new alignment in terms of risk\.
- [Similarities and Differences between Medical Device 510\(k\) and CE Marking](https://starfishmedical.com/resource/medical-device-510k-ce-marking/): Understanding similarities and differences between Medical Device 510\(k\) and CE Marking regulatory pathways helps harmonize overall regulatory strategy\.
- [RoHS 2 vs RoHS 3 Impact on Medical Devices](https://starfishmedical.com/resource/rohs-3-impact-on-medical-devices/): RoHS 3 \(EU 2015/863\) expands the list of prohibited substances from 6 to 10 adding 4 phthalates\. Learn if your device is RoHS 3 compliant\.

## Optional
- [Sitemap index](https://starfishmedical.com/sitemap_index.xml)