VICTORIA, B.C., December 1, 2015— StarFish Medical announces all of its medical device content– including checklists, whitepapers, and videos– are now downloadable without requiring email address or personal information.
“We create and share content to help others in the medtech industry benefit from our experience and expertise,” explains Scott Phillips, StarFish Medial President and Founder.
“After a two year trial, we decided we would rather reach everyone who is interested in the tools we create rather than just those who provide their personal data. We’ve switched to immediate access for all our new and existing content. Of course, we’d like to continue automatically updating those who like that service, so an optional sign-up form now appears with each content description and link.”
Current StarFish medical device development tools:
Clinical Input Increases Medical Device Success-Medical Device Basics
Part 1 of a series of videos on Medical Device Basics with three tips for Clinical Input. Scott illustrates the impact Clinical Input can make on Medical Device usability, functionality and market acceptance.
Value Chain and Margins Making Your Financial Costing Model Work– Medical Device Basics
Part 2 of a series of videos on Medical Device Basics. Learn how Cost of Goods Sold, Cost of Sales, and Gross Margins can make or break your Medical Device success.
Understanding the Root Problem– Medical Device Basics
Part 3 of a series of videos on Medical Device Basics. Scott includes examples from clients and colleagues to illustrate how Understanding the Root Problem can improve the design, cost, usability, and acceptance of your innovation.
Complying with Standards – Medical Device Basics
Part 4 of a series of videos on Medical Device Basics. Three key concepts will help you understand why Complying with Standards can improve your medical device’s design, cost, and time to market.
How to Identify Your Technology is Ready– Medical Device Basics
Part 5 of a series of videos on Medical Device Basics. Scott describes 3 time-tested methods to help determine if your technology is ready for manufacturing. You will learn the dangers of trying to commercialize too quickly, how to reduce your overall cost, and how to improve time to market for your Medical Device.
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. Determine and Interpret Your Results for:
- Intended Use
- Target Markets
- Device Risk Class & Product Code
- Regulatory Pathway
- Quality Management System
- Consensus standards
- Essential Performance
Other tools and guides
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.
Android™ vs. Apple Guide for Digital Health Medical Devices
Identify and compare your requirements on Android and Apple. Evaluate 21 areas with Digital Health device impact. Checklist identifies your medical device priorities. Confirm them with the Quick Check summary, then calculate how each platform stacks up for you. Comparison ratings include:
- Integrated Design tools
- Support for custom hardware solutions
- Fast, Friendly, and effective IDE
- Device Customization
- Device simulator and profiling tools
Pathfinder medical device product definition white paper
This product definition white paper 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.
- Value Chain and Margin
- Human Factors
- Consumable Strategy
Free One Hour No-obligation Commercialization Consultation
Expert advice from concept to Market-Ready. Medical device design and development professionals review your current medical device concept and activities, then provide recommendations drawing upon 16 years of experience and 100+ medical devices. Consult with subject experts, not sales staff. Gather personalized ideas and insights including:
- IP Opportunities and Issues
- Reimbursement Strategies
- User Factors
- Regulatory Requirements
Free Regulatory Consultation for Your Medical Device
Our team of medical device regulatory professionals will review your medical device and activities, then provide you recommendations drawing upon 16 years of experience with over 100 medical devices. Gather specific feedback on:
- US, EU, and Canadian requirements for your medical device
- Expected timelines and costs
- Potential hurdles or issues specific to your device
- Implementation Options and Resources
About StarFish Medical
StarFish Medical provides award-winning design, development, and flexible manufacturing outsourcing services —100% dedicated to the medical device and life science marketplace. StarFish partners with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including: Cardiovascular, Digital Health, IVD, Ophthalmology, Optics, and Ultrasound. StarFish expertise includes electronics, mechanical, human factors and software systems engineering.
Our proprietary Pathfinder™ process for medical device product definition saves clients time and resources throughout the technology and product development phases to commercialization. Prototype and low volume complex electro-mechanical production are delivered in an ISO 13485 certified facility with FDA registration, including cleanroom capabilities.
Regulatory and quality system (QMS) consultants at StarFish provide technical regulatory assistance for FDA and Health Canada submissions, including IEC 60601 and ISO13485.