Five Medical Device Commercialization Tips to Enable Success
Commercialization of a medical device is the process of transitioning from design and development to a realized, manufacturable, and sellable product. This blog describes how our commercialization team...
View Article2022 Top 10 Medical Device Commercialization Videos
StarFish Medical YouTube subscribers grew 50% in 2022. What medical device commercialization videos were they watching? Our 2022 top 10 medical device commercialization videos include six new videos...
View Article2022 Top Medical Device Blogs
Two new articles made the list of our most-read blogs for 2022. They join eight from last year’s top 10 covering a variety of topics including perspectives on equipment sterilization, firmware...
View ArticleMost Read 2022 Medical Device Articles
We share our newest and most interesting blog posts in a monthly newsletter. Inevitably some articles prove more popular than others, so we have consolidated a list of the most read 2022 Medical Device...
View ArticleOur Favorite Books in 2022
With holiday breaks looming, our bloggers and avid readers contributed a list of books they enjoyed most in 2022. It’s an eclectic mix – different, yet familiar to our list from 2021. The topics and...
View ArticleSimilarities and Differences between Medical Device 510(k) and CE Marking
This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects of an overall regulatory strategy....
View ArticleHow Post-Market Surveillance Enhances Medical Device Safety
Understanding Post-Market Surveillance: In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the post-market phase,...
View ArticleDesign for Testability
Many different aspects must be considered when designing a medical device. This is particularly true with more complex devices that rely on internal computers to support their function. Every device...
View ArticleUsing Language Models (AI) Responsibly In Medical Devices
Generative language models, colloquially known as “AI”, have been making waves across many different sectors in a wide range of roles, ranging from customer support chatbots to programming assistants,...
View ArticleDeveloping Class C Firmware for Medical Devices
You have done your Software Risk Analysis and have identified your Firmware to be of Software Safety Class C. What next? There are 3 points of the IEC 62304 Standard specific to the design of Class C...
View ArticleOverview of the New FDA Guidance on Cybersecurity
“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides guidance on integrating cybersecurity...
View ArticleCreating a Medical Device Bootscreen for QNX
Most if not all major devices (including medical devices) throughout the world have some form of a bootscreen. This often flashy but sometimes simple animation performs two purposes. One is simply that...
View ArticleThe Value of SBOMs and SBOM Analysis
The FDA recently published a new guidance on Cybersecurity and software in medical devices: “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. The...
View ArticleA Comparison of Detection and Imaging Methods Used in Optical Coherence...
Optical coherence tomography (OCT) is an imaging technique with many current and potential applications in medical devices. The most common medical uses of OCT are in ophthalmology and optometry, in...
View ArticleCommercializing Medical Devices with Optics
Commercializing a medical device with optical components brings a unique set of challenges. We asked our multi-disciplinary team of engineers, regulatory, manufacturing and optics experts to share...
View Article14 Ways to Increase Medical Device Speed to Market
Without sacrificing safety or quality Speed to market is a crucial part of medical device success. Our employee experts drew upon their experience with hundreds of medical device products for proven...
View Article10 Tips for Medical Device Optical-Breadboard Prototypes
When designing a medical device made of complex, multi-functional mutually interacting subsystems it’s best to de-risk those subsystems instead of coming up with a paper design, assembling it, and...
View Article12 Steps to Set up a Biomed Lab
Some lab managers get to manage a running lab, but others get a whole new challenge of being a lab manager where there is no lab yet. Each phase from having nothing to having everything in operational...
View ArticleFDA Guidance on Computational Modeling and Simulation in Medical Device...
The FDA’s Modeling & Simulation (M&S) Working Group of the Senior Science Council has noted that the use of Computational Modeling and Simulation (CM&S) is expected to increase in the...
View ArticleStarting Medical Device Projects on the Right Foot
New medical device projects are full of ups and downs with lots of surprises and twists along the way. We asked our employee experts to identify actions and advice that help ensure new medical device...
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