“We create and share medical device commercialization tools and content to help others in the medtech industry benefit from our experience and expertise,” – Scott Phillips, StarFish Medical President and Founder.
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Current StarFish Medical device commercialization tools:
Medical Device Playbook Events are now virtual. Canada’s premiere event for medical device professionals since 2015 has shifted to monthly webinars for the duration of COVID-19. Industry speakers and panels from across North America will converge online to discuss 2020 trends, opportunities, and strategies with other industry entrepreneurs and veterans.
Insights, examples and tips to improve NPI manufacturing performance for low volume, high compleity medical devices.
Tactics and examples of adapting KOL, formative, and summative research for COVID-19 guidelines. StarFish Medical’s ID / HF / UX team describe experiences from the Canadian Emergency Ventilators project and other devices.
StarFish Medical team members to share the experience, process, quality and innovation they bring to Medical Device entrepreneurs and organizations requiring QA/RA and QMS-in-a-Box assistance. This update focuses on 2020 QA/RA issues and opportunities.
Nick Allan, StarFish Medical Bio Services Manager, provides an overview of Point of Care (POC) infectious disease diagnostics and the role of medical device human factors.
View more videos on the StarFish Medical YouTube Channel.
Medical Device Product Definition Sanity Check
Easy to use Sanity Check for: Technology, User requirements, Workflow / Industrial Design / Human Factors, Reimbursement, Design for Manufacturability and Test. 50 Questions evaluate how your product definition plans stack up. Compare your plan with our Pathfinder™ Product Definition Process.
Medical Device Guide & Usability Framework
Framework to aid in informing the Usability Engineering component of your medical device development process. Use the questions to assess how well you have considered the usability needs for your Medical Device. Eliminate Usage Errors and Device Failures. Compare current efforts with our Proven Engineering Usability Framework.
Medical Device Regulatory Checklist
Self-assess your current regulatory commercialization plan. Inventory and analyse your medical device efforts by comparing your answers to understand your ability to meet applicable regulatory requirements.
The question of how much time and money it will cost to develop a medical device is a challenging one to address. This white paper examines the costs associated with a ‘No Design’ Product, the differential between the cost to develop a device versus the total fundraised amounts, a review of an industry staple survey for the total raised funds for medical devices, and an article focused on Point of Care Diagnostic Devices.
Designed for readers considering, choosing, or implementing a laser-based technology in the device they are developing; this whitepaper discusses the principles of operation of lasers, their useful properties, and their interactions with biological tissues, along with a non-exhaustive overview of the myriad ways in which they have been applied in medicine.
Pathfinder medical device product definition whitepaper
This whitepaper details areas to explore during product definition. It examines actual experiences and successful strategies. 90% of Medical Device success is created during product definition. Learn how to interpret your market and product requirements.
FDA Medical Device Classification Quiz
Test your knowledge of the FDA medical device classification system with our FDA Medical Device Classification Quiz. The FDA divides medical devices into Class I, II, and III according to the risk posed by the device. Regulatory controls increase from Class I to Class III. Our quiz includes a wide variety of devices. You try to choose the correct classification and learn while having fun.
Electrical Safety & Quality Testing eGuide
This eGuide is based on a BIOMEDBoston Learning Lab and includes suggestions to make the testing process easier. Topics include: Important Standards for Medical Device Development, the Application of Risk Management to Medical Devices, Use Error Examples, and Reliability Testing required for Compliance. Includes resources and examples.
Empowering Medtech Innovation®
StarFish Medical is a full service Medical Device Design company offering design, development, and manufacturing services based in Toronto and Victoria. We use our Pathfinder™ process to reduce wasted effort and increase success for medical device product definition, technical engineering, and product development. Prototype and volume production are delivered within an ISO 13485 certified Quality Management System. manufacturing and clean room facilities. www.starfishmedical.com