This week, we got to participate in an industry course on medical device implementation taught by Dr. Richardson. This course was hosted at Establishment Labs in Coyol, and our fellow students were employees at various medical device companies here in Costa Rica. As Dr. Richardson explained, the Research and Development (R&D) phase of medtech innovation only counts for about 10-20% of the time and work that goes into the creation of a new device. The other 80-90% is implementation, and this is composed of intellectual property, manufacturing, quality, regulatory, clinical, reimbursement, sale, and marketing. Learning more about these processes and strategies are critical for any engineer because all of these processes are very interconnected, and have a huge effect on the success of a device.
This course followed a case-study structure, and each group was encouraged to select a recently released medical device so that we could apply the concepts learned in class to this device. We would present on these findings in a showcase at the end of the week. My group, composed of Valeria, Carlos, and Jose, selected an ablation catheter released by Boston Scientific – the IntellaTip MiFi XP. This catheter utilizes mini-electrodes at its tip in order to help cardiologists localize the device with increased efficiency. With this device in mind, we conducted patent searches, identified ways to improve its design and assembly for manufacturing, developed a regulatory assessment and clinical strategy, and so much more. It was really interesting to see how these concepts we were learning about in the classroom were applied to a real device that is now in use, and I found this final short course to be very valuable at increasing my knowledge of the medtech industry.
This course was our final short course for the summer, and really brought our learning full circle. Our first course with Paul Fearis focused on needs-finding – the crucial formative stages of device design. Our next course with Dr. Wettergreen and Dr. Richardson focused on the design process, and this course was great for getting some hands-on experience. Our final course dealt with everything that happens after design, and was a great course to have right before our internship.
At the end of the week, Establishment Labs graciously allowed us to tour their manufacturing line. Establishment Labs is a Costa Rican-founded company that produces breast implants, and the factory was incredible! It was awesome to see the level of detail that goes into each and every product, and how intricately the line is designed. It got me thinking more deeply about how much planning and thought goes into something as seemingly simple as a breast implant, and got me really excited for my internship!
Speaking of, our internship starts tomorrow morning. I’m so excited and feeling blessed to take on the challenges of the next 6 weeks at Boston Scientific!