Cardiovascular Systems Inc. is a medical device company based out of Minnesota that specializes in developing and commercializing medical solutions to treat peripheral and coronary artery disease (also referred to as PAD and CAD). To help fight against these diseases, CSI has adopted 3D printing across all facets of their business with growing success with patient treatments.
The Research & Development team use 3D printing to not only prototype but also simulate clinical environments. Will Besser, Senior Product Development Engineer at CSI says “with 3D printing, we can be very quick in our process by developing a prototype component one week and then gather feedback from physicians the next week”. He carries on by adding, “the earlier in the development process you find and fix issues, the less expensive it is. That’s where rapid prototyping really shines, it helps get actual physical objects in your hand, saving us time and money”. With 3D printed models in hand, CSI evaluates performances based on the imaging data taken from patients as 3D recreations of the patient’s anatomy allow for more efficient clinical feedback.
“We take angiographic images and use 3D modeling to recreate the complex anatomy of different coronary vessels, 3D print a realistic model and stress test different situations to see where we can improve our device,” said Nick Ellering, a product development engineering manager.
CSI’s Reliability Engineering team also benefits from in-house 3D printing during failure analysis process on complaint devices, in addition to standard failure analysis procedures. “We’re able to quickly model clinically relevant anatomical pathways to recreate field failures on the bench in an effort to understand the mechanism by which they occurred,” said Henisha Dhandhusaria, a reliability engineer. “We experiment with different vessel path models and print materials while making iterative design modifications to the models during failure analysis investigations. This helps find the root cause of failure more efficiently and in a controlled manner.”
Printing with Stratasys PolyJet technology allows the models to incorporate both soft tissue vessels and hard calcification analogs within the same model to replicate atherosclerosis. Once the device has been deployed in a 3D printed model, CSI splits the model in two so engineers can measure how effectively the device removed calcifications from different types of vessels. “It’s a great way to get instantaneous feedback,” said Jake Draxler, a product development engineer. “We’ve also experimented with multi-colored, multi-layered materials. As our device removes simulated lesion material, we can easily see and measure how far into the multicolored layers it’s orbiting.”