Medical Device Commercialization Tools

Medical Device Manufacturing SOP

 

“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:

Webinars

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.

View full list of upcoming and recorded Virtual Medical device Playbook webinars.

Videos

Biomanufacturing, Dx Assay Technologies and Advanced Cellular Therapies

Learn about Biomanufacturing, Dx Assay Technologies and Advanced Cellular Therapies from the Bio Services team at StarFish Medical. It’s a really interesting area.

Industrial Design/Human Factors/User Experience for Medical Devices

Often commercializing medical devices will require Industrial Design, Human Factors and User Experience expertise. In this video, hear insights on design strategy, the impact of Algorithm Aided design, formative studies, and human factor strategy.

Medical Device QA / RA Insights and Tips

Medical Device QA / RA experts from StarFish Medical share tips and insights on topics including medical device labelling, regulatory strategies auditing, and reimbursement.

Microfluidics Medical Device Expertise

StarFish Medical experts share insights and examples of how to integrate microfluidics into a Point of Care (POC) diagnostic medical device.

Medical Device Optics Expertise

Optics play an important part of many medical devices in diagnostic therapeutic, and biotech imaging applications. Engineering experts in Optics, Electronics, and Mechanics share medical device examples, tips and insights in this overview of StarFish Medical Device Optics Expertise.

Optics Tips for Medical Devices

Optics Tips for Medical Devices are shared by StarFish Medical Optics, Electrical and Mechanical Engineers. StarFish Medical is a full service medical device design, development, and manufacturing service provider.

Microfluidics, Cell Therapy, and Infectious Disease Medical Device Expertise

StarFish Medical Bio Services and business development team members share insights and expertise on medical device projects involving microfluidics, cell therapy, and infectious disease in our latest Bio Services video. 

View more videos on the StarFish Medical YouTube Channel.

Checklists

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 UPDATED MARCH 2022

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.

Whitepapers and other tools

Writing an Effective Medical Device Manufacturing SOP

This StarFish eGuide covers 7 steps to write an effective medical device manufacturing SOP. Writing and implementing Medical Device Manufacturing SOPs (standard operating procedures) is required by ISO 13485, FDA, and other regulatory bodies.

FDA Cybersecurity Draft Guidance

StarFish Analysis of the FDA Cybersecurity draft guidance released on April 2022, intended to align medical device development with current best practices from other industries. This whitepaper reviews new requirements and considers their impact on medical device developments.

Premarket Submissions of Device Software Functions

StarFish Analysis of November 4th, 2021, FDA draft guidance: Content of Premarket
Submissions for Device Software Functions examines how the new guidance changes current medical device requirements.

US Reimbursement Codes 101

This primer provides an overview of US reimbursement codes and when they are used to help determine coverage and payment for medical devices.

How Much Does it Cost to Develop a Medical Device?

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.

Lasers in Medical 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.

About StarFish Medical

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

Media Contact:

Mike Camplin | mcamplin@starfishmedical.com | 250.388.3537 ext. 210 | www.StarFishMedical.com

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