New ways of thinking encourage new ideas and ultimately new products!
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New ways of thinking encourage new ideas and ultimately new products!
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The following is a transcript of a presentation to the
Vascular Sciences mission is simple: to bring the human body to the bench-top. What do we mean by bringing the human body to the bench-top? Well, Vascular Sciences makes physical models that simulate the functions of the human body. We call these functional models biosimulationsTM. What do we mean by functional biosimulationTM? Well consider this anatomical model of the heart. This model is static, it doesn’t do anything. In other words, it’s not functional. If I was designing a medical device, a catheter, for example, I couldn’t introduce this catheter into this heart. Its solid. There’s no movement. No blood flow. It doesn’t do anything. Vascular Sciences models or biosimulationsTM are functional. That is, they function like the body does. There’s movement. There’s blood flow. Well, simulated blood. It’s warm. It looks, it feels, it responds like the body does. A very powerful feature of Vascular Sciences biosimulationTM tools is their adaptability. We’ve developed a proprietary technology which we call plug-n-play pathologies which allows a user to plug in a stenosis, and aneurysm, an obstruction, virtually any type of pathology any where in the biosimulationTM to be able to recreate almost any clinical condition imaginable. And best of all, these plug-n-play pathologies can be ordered right out of a catalog we’re developing even as we speak. Simply open the catalog to the aneurysm section, choose the shape and size of aneurysm you need, plug it into the model and that’s it! You’re ready use your device just like if your were the physician in the cath lab. Why are these functional models or biosimulationsTM important? Well, for one, can you say FDA??? This past summer, the FDA adopted its newest round of GMP regulations which, among other things, now require simulation testing of all non-exempt Class II and Class III medical devices. Let me read a short section of the new GMP code to you.
So the key phrase here is testing of production units under actual or simulated use conditions. So what FDA is saying is that each manufacturer must conduct simulation testing but they’re not specific on how to do it. Since this code is new, there’s not a lot of precedent yet. So, Vascular Sciences has been working directly with the folks at FDA who wrote this section of the GMP to help clarify what is actually required. To that end, Vascular Sciences will be publishing an article in the MDDI magazine in March 98 detailing simulation-testing options. So one application for Vascular Sciences functional biosimulationTM tools is to help medical device manufacturers meet this new GMP requirement. Where else can this functional models or biosimulationsTM be used? Well, consider this scenario. One of your R&D engineers builds a prototype of a device that you think might make your product superior to that of your competitors. But how can you know for sure? You need a fast, convenient way to test your prototype without the time and expense of an animal study. Your engineer simply walks over the your biosimulationTM sitting in the corner of your lab, and in a short period of time, you know whether or not this new design is worth pursuing. What about other uses of Vascular Sciences biosimulationTM technology? Well, think about the last time you attended a clinical trade-show. Where were the people gathered? You may have noticed that people tend to gather where there is some activity, some interaction taking place. Imagine you have one of Vascular Sciences biosimulationsTM at your booth not just sitting there, but with tissues moving, blood pumping, looking, acting, responding like a real patient. You have your new product available for physicians to try out in vivo. Well, OK, in vitro but with Vascular Sciences biosimulationTM technology, its hard to tell the difference. And if you’re a bit daring, you might have your competitors product available to try as well. That’s pretty powerful marketing. Another interesting application of Vascular Sciences biosimulationTM is in physician training. I’ve talked to many cardiologists, for example, who are really not comfortable with the idea of doing their first angioplasty on a living patient. Imagine being able to offer your customers the ability to practice using your products before it really counts. So remember, Vascular Sciences biosimulationTM tools provide a convenient, cost-effective and reproducible method of creating the look, feel and responsiveness of the human body to a variety of medical device products and procedures. In other words, bringing the human body to the bench-top. |
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