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I suggest that Regenerative Medicine will be associated with a parallel revolution in medicine- much like introduction of the world wide web and the internet in the ’90s caused a revolution in global communications and information technologies. As with all revolutions, history records that there are those that can thrive, adapt and ride the tides of change, and those that do not. I prefer to ride the wave.continue reading »
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Chimeric antigen receptor T-cell (CAR-T) therapy is a rising shining star in Regenerative Medicine. Medical devices will be involved in many of the processes involved with CAR-T therapies. From blood collection, to T-cell isolation and activation, modification, expansion and product formulation, preconditioning and finally T-Cell infusion and delivery, there will be an evolution in the associated medical devices to support a treatment worthy of a ‘miracle cure moniker’.continue reading »
“When do I need a Quality Management System (QMS)?” is the most common question that we get asked by new clients who are just entering into the medical device field. The answer depends on your target market and your exit strategy. To be frank, it is somewhat a chicken and egg thing.continue reading »
StarFish Medical videos are created to help viewers learn about medical device design, development and manufacture. They are also a great way to get a better sense of the people you will be partnering with at StarFish.continue reading »
Using Matched Filters
Anyone who has taken a signals and communications course has likely heard of matched filters. Intuitively these filters use knowledge of the form of a transmitted signal to pull it out of the noise. Matched filter theory or related concepts are commonly used in RF communication but I often apply it to other signals, such as sensor measurements in medical devices.continue reading »
When choosing a manufacturer to launch your medical device, there are a lot of things to consider and options to compare. Cost, quality and lead time usually lead the list. Which ones are most important for your device? In this blog I’m going to focus on an often overlooked attribute that should be a high priority in any launch plan.continue reading »
Many entrepreneurs underestimate the importance of ramping up medical device manufacturing in a small and controlled way – sort of a slow ramp. They often overestimate how quickly they’re going to require high volume and underestimate the value of post-release design changes and the effort that will be required in early launch.continue reading »
Looking for a good resolution to improve your medical device commercialization in 2019? Here are 9 great resolutions recommended by our team of engineers, designers, QA/RA, and manufacturing professionals.
Four new medtech blogs and three new authors joined our 2018 “most read” list. Regulatory was the most popular topic, followed by electrical engineering, software, and supply chain.
The most common question supply chain professionals get from clients is “How can we reduce the cost of this project?” Cost reduction is always a challenge – especially in a low volume, complex manufacturing environment.