As a Master of Mechanical Engineering student at the University of Massachusetts Amherst, I had the incredible opportunity to dive into a practical medical device design class this past semester. This hands-on course focused on the practical side of medical device designing, not necessarily reinventing the wheel but refining and adjusting existing products to make them more effective and compliant with industry standards.
In this blog, I’m excited to share some of the CAD models and designs I created during the course. From brainstorming innovative concepts to incorporating ISO standards and FDA requirements into the design process, the class offered a deep understanding of how real-world constraints shape product development. Whether you’re a fellow engineering enthusiast or just curious about the process behind medical device design, I hope you’ll enjoy this glimpse into my work!
Balloon Catheter Design
The first major project was designing a balloon catheter intended to navigate through pulmonary veins. This project provided invaluable insights into the importance of material selection and the tradeoffs involved in optimizing material properties and product dimensions. For this prototype, Pebax was chosen as the primary material due to its availability and favorable performance under buckling forces compared to alternatives like Nylon 6. The design required careful adjustments to meet dual-lumen functionality and adhere to ISO 594 standards, ensuring compatibility with other medical devices. While Nylon would be the ideal material for its balance of torqueability and bending moment, Pebax met the performance requirements within the scope of this project. Below is a glimpse of the design and key details about the material selection, dimensions, and balloon placement!
Bipolar Ablation Probe
One of my favorite projects was designing a bipolar ablation probe for liver cancer treatment using Irreversible Electroporation (IRE) therapy. This project combined mechanical and biological engineering, as we optimized electrode geometry and simulated electric fields to maximize tumor ablation while minimizing patient trauma. Through CAD modeling and finite element analysis, we developed a detailed design that balanced clinical requirements with engineering constraints
Hemostatic Valve Connector
For this project, we designed a hemostatic valve connector to minimize blood loss and secure guidewires during vascular catheter procedures. Using SOLIDWORKS, we developed a single-part Y-connector design that incorporates a hemostatic seal, guidewire clamp, and ISO-compliant Luer connections. The prototype was manufactured through rapid 3D printing and tested for leakage, durability, and functionality, ensuring compliance with FDA and ISO standards.
Pill Case
This was just a fun little exercise we did to get back in the swing of SOLIDWORKS. This project taught me about the flex feature in SOLIDWORKS that I was unfamiliar with before!