FDA Guidance on Non-Clinical Bench Performance Testing Information
Your Roadmap for Premarket Submissions Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your...
View ArticleAdjusting Human Factors Processes for COVID-19: Remote Creativity
New COVID-19 measures to protect our safety limit some human factors usability studies from being executed through traditional in-person facilitation. This blog identifies creative ‘COVID-19 friendly’...
View ArticleHow Regulators are addressing COVID-19 related Medical Device approvals
This blog gives a snapshot of what the FDA, Health Canada and the European Commission have put in place to fast-track COVID-19 related Medical Device approvals and provide quicker access to medical...
View ArticleHealth Canada improvements: Getting new devices to market
It’s always great to spend time with regulators to understand their point of view on the regulations and guidances they provide to us. It is also helpful to hear about the changes going on at Health...
View ArticleDIY COVID-19 Medical Devices
One response to possible COVID-19 medical device shortages is to try to hack DIY COVID-19 medical devices together. It’s very empowering to see open-source communities come together to try to turn out...
View ArticleWhy a CoVID-19 Point of Care Diagnostic will help insure our future
What is a coronavirus and why a CoVID-19 Point of Care Diagnostic is so important The virus that causes CoViD19 is a coronavirus. The viruses are so called because the virus physically looks like a...
View ArticleFive Supply Chain Tips for COVID-19
The world of Supply Chain management changed in the first quarter of 2020. As the coronavirus spreads, and more and more people are affected by COVID-19, supply chains around the world continue to be...
View ArticleLaser Speckle Contrast Imaging: Visualize Invisible Fluid Flows
How to build a breadboard proof-of-concept system It’s advantageous, when possible, for medical techniques to be non-invasive and inexpensive. One method of imaging flow (of blood and other optically...
View ArticleOptics handling during manufacturing
Our Optics experts and manufacturing leaders met to identify lessons learned and tips from recent projects involving optics handling during manufacturing, prototyping and transfer to manufacturing....
View ArticleIn-Person vs. Virtual Training: Comparing Results
Hidden In-Person vs. Virtual Training Benefits and Tips for COVID-19 and Beyond In this COVID-19 time, while many of our clients were canceling training programs, StarFish Medical continues investing...
View Article8 Tips to implement POC diagnostic platform optical detection
This blog offers eight tips to help successfully implement a POC diagnostic platform optical detection with a disposable microfluidic cartridge. With the changing healthcare ecosystem, demand for...
View ArticleFive recommendations for approaching medical device optics projects
Five powerful perspectives for the Optics Laboratory Implementing medical device optics projects like a novel measurement scheme, or bringing up a breadboard prototype for the first time, is a dynamic...
View ArticleScience Fiction Medical Devices
Real medical devices from the imagination of science fiction Many shows, movies, books and videogames feature science fiction medical devices and technologies that seem otherworldly and far beyond our...
View ArticleWhere do you find inspiration for work?
Many have paused work for a COVID-19 required break. As an essential business, our work did not pause. We asked our content team of engineers, regulatory, quality, design, and program management...
View ArticleUsing Smartphones as a Medical Device for Point-of-Care Applications
What makes smartphones as a medical device exciting as potential point of care platform? Smartphones are the most widely used portable devices in the world today. According to Statita, the number of...
View ArticleSpectrometer from home materials
Make a real-time, wavelength-calibrated spectrometer using common household items. Like many others, I’m currently working from home due to the ongoing COVID-19 crisis. Fortunately, a significant...
View ArticleBetter brainstorming for medical device product development
This blog is about better brainstorming for medical device product development and includes using a systematic method of brainstorming that may help highlight higher quality concepts before detailed...
View ArticleWhich standards apply to your medical device?
This blog shares how to identify which medical device standards apply to the device you’re bringing to market and provides an overview of major standards at various regulatory levels for novices. The...
View ArticleMitigating the parasitic properties of capacitors
This article is about the parasitic properties of capacitors. It discusses the issues they cause, mitigating the parasitic properties, and even how to turn them into something useful. Note: This...
View ArticleReference designs for medical device development
Reference designs for medical device development are a great way to ramp up a project faster and more cost effectively. At work, we’ve adopted a strategy of developing our own reference designs of...
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