dreamstime_xs_27707049From 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 be transferred and quoted by a 3D printing company almost instantly. Many 3D printing companies return parts to the designer within 24 hours. This decreases timelines for the overall design iteration process, as verification of components is performed promptly upon receipt of parts.
What processes are available and what are their relative merits? Several techniques are employed at commercial scale.  In this blog I outline and compare three of the most commonly used in medtech product development.

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Medical device comfort on a cold winter’s day

medical device comfort
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 you’re trying to get some sleep… probably not so comfortable anymore!
Comfort is subjective. There are thousands and thousands of permeations in nearly any situation that can cause comfort or discomfort and any rating in between. These include mental, physical and temporal demands multiplied by your own performance, frustration and the amount of effort required.

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StarFish bloggers in meeting for their “day job”.

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 colleagues (current and future) learn about us and our work.
Every month we get together over a lunch to see what got read, clicked, liked and shared.  This article is a summary of the most clicked newsletter items during 2016.  Now’s your chance to see what everyone else was checking out.

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off the shelf components dreamstime_xs_4320532When 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 needs, and usually these deficiencies are obvious. The problem arises when we unconsciously ask for more than the original widget design requires.

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Prototype 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 questions: “What quality do you really need?”, and “How many are you making?”

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Supplier Quality AgreementIn 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 certificate of conformance —what other paperwork is needed? Why clutter up a simple, well defined process with other documents and paperwork?

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<!-- HTML Credit Code for Can Stock Photo --> <a href="http://www.canstockphoto.com">(c) Can Stock Photo / bloopiers</a>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 portion thereof – need to consider biocompatibility requirements. But not to worry, the rigors of compliance vary depending on the nature and duration of contact: requirements for skin contact electrodes and pacemakers are not equal. This blog is filled with wisdom I’ve gained while developing a spinal surgery instrument.

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silicone moudling strategiesTwo 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 identified the most critical specifications to focus on when choosing an RTV (room temperature vulcanization) silicone to be used in moulded parts. In this blog I will cover how to mould silicone parts.

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