While every inventor wants his/her product to reach the market first, it is not often an easy task. The technical capabilities required are many in number and the unknowns are greater.
This is even truer for medical device first-time entrepreneurs who have a prototype and are maneuvering through processes, FDA requirements, certifications and mass manufacturing know-hows. A medical device almost always is a combination of hardware, firmware and software, forming the essential components of the product.
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In 2016, I had the exciting opportunity to join StarFish Medical’s electrical engineering department for an eight-month co-op. I ended up enjoying the fast paced, exciting, hands on work so much that I returned during my fourth year of studies and have since continued into a full-time job since graduating this past spring.
Electromagnetic Compatibility (EMC) testing is a key part of device development for medical or other devices. It consists of two different sets of tests: Emissions testing, and immunity testing. As you might guess from the name, emissions testing looks at the electromagnetic emissions from the device under test (DUT), while immunity testing looks at what happens to the DUT when it’s subjected to electromagnetic emissions from an outside source.
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.
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.
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’.
“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 
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.
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.