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Tag: StarFish Medical

33 Solid Medical Device Manufacturing Tips

This blog covers 33 tips and examples from sixteen StarFish Medical experts for Phase Three Manufacturing of medical device commercialization.Tips for all four phases...

Using The FDA’s Best Practices for Selecting a Predicate Device

One of the more common pathways to commercialize a medical device into the United States is through the 510(k) marketing submission, also known as...

Pro Tips for Medical Device Transfer to Manufacturing

Medical device commercialization is typically broken into Four Phases: Phase Zero Product Definition, Phase One Engineering Design and Development, Phase Two Transfer, and Phase Three...

Comparing HP 8753 and NanoVNA For Medical Device Design

This blog compares a traditional Vector Network Analyzer (VNA), the HP 8753, with a NanoVNA for use by the budget constrained engineer developing a...

What To Look For When Choosing a Medical Device Contractor

Choosing a medical device contractor is one of the most important decisions a medical device start-up can make.In today’s distributed workforce environment, finding a...

How to Improve Emotional Interaction With a Medical Device

Visual rhetoric and emotional interaction in Medical DevicesFrequently in the medical device industry, the tangible importance of the aesthetic design of an object can...

Creating a Custom-Built Reflow Oven

A fun side-project that I worked on during my co-op term here at StarFish Medical was a custom-built reflow oven to solder surface mount...

Variations Between FDA and EU MDR Requirements for Clinical Investigations

Clinical investigations are defined within both FDA and EU MDR as the systematic investigation involving one or more human subjects, undertaken to collect data...

Medical Device Phase One Product Development Pro Tips

Our employee experts share their best tips and examples for each phase of the commercialization process in a four-part series on Medical Device Commercialization....

Look Before you Lead: Planning for Summative / Human Factors Validation Testing

Human factors validation testing is the final usability testing to be completed prior to regulatory submission. A mistake or an omission may result in...

Patient-Centered Design

Patient-centered design is designing healthcare with the patient in mind, a methodology that prioritizes the patient’s desires and requirements. This encompasses constructing medical facilities,...

How to Leverage PCB Mounted Microfluidic Cartridge Components  

Microfluidic point-of-care assays are a hot topic nowadays and there’s lots of buzz surrounding how to make inexpensive, quick and reliable cartridges. One area that...

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