7 Benefits of Using Adaptive Design for Clinical Studies
What is adaptive design for clinical study and why is the Medical Device community so excited about it? An adaptive design for a medical device clinical study is defined as a clinical trial design that...
View Article4 ways to make your jig design process more effective
Jigs are used quite heavily in research and development. They make our lives easier and help us conduct tests and collect data when needed. Here are 4 ways to make your jig design process more...
View ArticleMedical applications and early stage design- silicone material selection
We often design elastomeric components that will be used in contact with the human body, and silicone is usually our “go-to” material. Attractive for many reasons, silicone can be used from early stage...
View ArticleFDA inspection results from 3 different preparation strategies
This is the second blog in series of three that cover our recent experience with FDA inspections of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical...
View Article17 Lessons learned from 3 FDA inspection strategies and results
This is the third blog in series of three that cover our recent experience with FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical...
View ArticleThe race to value-based care: a medtech perspective
Medtech companies that innovate with value-based care in mind will be well positioned In a video interview published by MDDI, Omar Ishrak, the CEO of Medtronic, describes the biggest threat to the...
View ArticleIs your digital health strategy “bubble-proof”?
The digital health market is starting to remind me of the dot-com bubble, when anything internet went from boom to bust. Back in 1998 I was with a start-up company that monitored equipment health,...
View ArticleSilicone moulding strategies for medical applications
Two key variables in rapid silicone prototyping are material selection and silicone moulding strategy. In my “Medical applications and early stage design – silicone material selection” blog, I...
View ArticleA design engineer’s perspective of medical device biocompatibility
Designing a medical device, but not sure whether it needs to be biocompatible? Will the device have direct or indirect human contact? If the answer is yes, read on! Most devices – or human contacting...
View ArticleSupplier Quality Agreement or Supply Agreement?
In the early stages of medical device development, it is usually sufficient to secure pre- production quantities through a simplified procurement cycle. A specification, a quote, a purchase order and a...
View ArticlePrototype vs Production tooling
“What’s the difference between production vs prototype tooling?” and “What quality can I expect?” are often questions that I get asked from development or clients. The best answer begins with other...
View ArticleOff the shelf components in medical devices
When developing a medical device, it’s easier both in time and effort not to reinvent the wheel. Sometimes, off-the-shelf (OTS, or COTS – commercial off the shelf) components don’t meet the device...
View ArticleNew US clinical trial information reporting rule starts January 2017
Are you ready? The final rule for clinical trial information reporting was published by the United States National Institutes of Health, Department of Health and Human Services in September 2016 and...
View ArticleStarFish year in review: Most clicked newsletter items of 2016
Our content reflects topics that interest and engage StarFish employees. We encourage everyone to write, participate in videos, make public presentations and help our clients (current and future) and...
View ArticleOur 10 most read medical device blogs of 2016
Our annual summary of most read medical device blogs is always popular. This year it may also feel familiar. The top four blogs were previously on last year’s list. What makes them stand the test of...
View Article10 most viewed 2016 StarFish Medical videos
Think you’ve seen it all? Then check out our most viewed 2016 StarFish Medical videos. Five new entries join this year’s list. Perfect for viewing during breaks in your holiday schedule. The most...
View ArticleHow do you address the subjectivity of medical device comfort?
Medical device comfort on a cold winter’s day When you climb into bed at night and wrap yourself up in a nice warm blanket, you’re comfortable, right? What happens if it’s really hot and humid out and...
View ArticleMedical device miniaturization options and trade-offs
Smart watches, near field tags, fitness trackers – everywhere you look, electronics are getting smaller. Medical devices are no exception, with many medical device manufacturers targeting very small...
View ArticleCompare 3D printing prototyping merits for three common processes
From form studies to functional components at the early stages of prototyping to full production, the applications for 3D printed parts are growing rapidly. Parts designed in 3D modeling software can...
View Article6 Tips for designing a medical device PCB prototype
Designing a printed circuit board (PCB)? Is it for a prototype? I’m a Junior Electrical Engineer at StarFish Medical. This article summarizes some of the things that I’ve learned since I’ve been here....
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